58 results on '"Burnett AL"'
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2. (176) Prior Intracavernosal Injection Therapy and Prostate Cancer Treatment are Both Independently Associated with Increased Risks of Complications in Men Undergoing Inflatable Penile Prosthesis Placement.
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Jones, JM, Barham, DW, Gross, MS, Chang, C, Hammad, MAM, Swerdloff, D, Miller, J, Andrianne, R, Burnett, AL, Gross, K, Hatzichristodoulou, G, Hotaling, JM, Hsieh, TC, Jones, A, Lentz, A, Modgil, V, Osmonov, D, Park, SH, Pearce, I, and Perito, P
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PENILE prostheses , *PROSTATE cancer , *CANCER treatment , *EMPLOYEE ownership , *RADICAL prostatectomy , *SURGICAL complications - Abstract
Introduction: Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective: To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods: A retrospective cohort study of primary IPP cases from 2016-2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results: A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p<0.001) and/or radiation (5.51% vs 10.9%, p<0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions: In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure: Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts. [ABSTRACT FROM AUTHOR]
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- 2024
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3. New findings regarding predictors of Poor Corporal Integrity in Penile Implant Recipients: A Multicenter International Invesigation.
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Chang C, Barham DW, Dalimov Z, Swerdloff D, Sadeghi-Nejad H, Andrianne R, Sempels M, Hsieh TC, Hatzichristodoulou G, Hammad M, Miller J, Osmonov D, Lentz A, Perito P, Suarez-Sarmiento A, Hotaling J, Gross K, Jones JM, van Renterghem K, Park SH, Warner JN, Ziegelmann M, Modgil V, Jones A, Pearce I, Burnett AL, Gross MS, Yafi FA, and Simhan J
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Objectives: To evaluate the pre- and intraoperative variables that impact the integrity of the corporal bodies over time after inflatable penile prosthesis (IPP) placement, as predictors of intraoperative corporal perforation and delayed cylinder complications have not been well characterized., Patients and Methods: We retrospectively reviewed a 16-centre multi-institutional database of IPP surgeries performed by experienced implanters from 2016 to 2021. Poor corporal integrity (PCI) was defined as intraoperative (iPCI) corporal complications or postoperative (pPCI) corporal complications. Multivariable analysis was performed to identify independent predictors of PCI, iPCI, and pPCI. Primary outcomes included intra- and postoperative corporal complications., Results: We identified 5153 patients for analysis from 5406 IPP cases, finding 152 (2.95%) cases of PCI. On multivariable analysis, predictors of PCI included revision IPP surgery (odds ratio [OR] 8.16, 95% confidence interval [CI] 5.15-12.92; P < 0.001), sequential dilatation (OR 2.12, 95% CI 1.32-3.39; P = 0.002), coronary artery disease (CAD)/peripheral vascular disease (PVD) (OR 1.81, 95% CI 1.18-2.77; P = 0.006), older age (OR 1.02, 95% CI 1.01-1.04; P = 0.013), and corporal scarring (OR 1.58, 95% CI 1.0-2.5; P = 0.049). Predictors of iPCI included revision IPP surgery (OR 7.34, 95% CI 4.18-12.88; P < 0.001), corporal scarring (OR 2.77, 95% CI 1.64-4.69; P < 0.001), radiation therapy (OR 2.25, 95% CI 1.0-5.04; P = 0.049), and older age (OR 1.03, 95% CI 1.0-1.05; P = 0.025). Revision IPP surgery (OR 7.92, 95% CI 3.69-17.01; P < 0.001), sequential dilatation (OR 3.4, 95% CI 1.61-7.19; P = 0.001), CAD/PVD (OR 2.98, 95% CI 1.56-5.72; P = 0.001), and history of priapism (OR 3.59, 95% CI 1.08-11.99; P = 0.038) were predictive of pPCI., Conclusion: Coronary artery disease/PVD, being of older age, having corporal scarring, undergoing IPP revision surgery and sequential dilatation were predictive risk factors for complications associated with PCI. Identifying patients who are at risk of having PCI may improve patient-specific counselling, consideration of referral to more experienced implanters, and surgical planning to potentially promote longer-term device viability., (© 2024 BJU International.)
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- 2024
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4. Mapping of functional erectogenic nerves on the rat prostate.
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Unal S, Mi R, Musicki B, Hoke A, and Burnett AL
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Background: Preservation of erectogenic nerves during radical prostatectomy (RP) is hampered by limited understanding of their precise localization, due to their complex, intertwined paths, and the inherent individual variations across patients. Because erection utilizes a subset of cavernous nerves (CNs) that in response to sexual stimuli reveal phosphorylation of neuronal nitric oxide synthase (nNOS) on its stimulatory site Ser-1412, we hypothesized that delineation of nerves containing phosphorylated (P)-nNOS on Ser-1412 would establish the location of functional erectogenic nerves within the periprostatic region., Aim: To identify the distribution and quantity of functional erection-relevant ([P-nNOS]-containing) nerves in the periprostatic area and discriminate them among the CNs distribution. We further evaluated whether functional communication exists between contralateral CNs., Methods: Young adult male Sprague-Dawley rats underwent electrical stimulation of the CNs to induce penile erection via phosphorylation of nNOS on Ser-1412 (6 V for 2 min, n = 6). No stimulation group served as control (n = 6). The prostate and adjacent structures were collected and processed for whole-mount double-staining with TuJ1 antibody (a pan-axonal marker) and P-nNOS (n = 3 for stimulation, n = 3 for no stimulation), or total nNOS and P-nNOS (n = 3 for stimulation, n = 3 for no stimulation), followed by modified optical clearing and microscopic examination. Nerve quantification was done by systematic counting., Outcomes: Location and quantification of functional erectogenic nerves., Results: In the male rat, we obtained a map of P-nNOS-containing nerves in the periprostatic area, which are relevant for penile erection. Only 17.5% of all nerves, and only 28.4% of the total nNOS-containing nerves in the periprostatic region are functionally erectogenic nerves. Furthermore, there is no functional innervation between contralateral (stimulated and non-stimulated) CNs., Clinical Implications: This basic science study is expected to provide a foundation for subsequent studies at the human level. Understanding the erection-relevant nerve distribution in the periprostatic area is expected to advance nerve-sparing RP at the human level to improve sexual function outcomes., Strengths and Limitations: This is the first study to describe and quantitate a subset of functional erection-relevant (P-nNOS-containing) nerves in the periprostatic area. Our study differs from previous studies where nerves containing total nNOS were localized without specifying which nerves produce erection. However, because this study comprised a relatively small number of rats, further studies with a bigger sample size or other model animals are warranted., Conclusion: Only a subset of nerve fibers in the periprostatic region represent functional erectogenic nerves, characterized by the expression of P-nNOS (Ser-1412)., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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5. Niclosamide attenuates erectile dysfunction and corporal fibrosis via reversal of Smad signaling in diabetic rat model.
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Engin S, Barut EN, Kaya Yaşar Y, Işık S, Kerimoğlu G, Burnett AL, and Sezen SF
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- Animals, Male, Rats, Penis drug effects, Penis pathology, Smad3 Protein metabolism, Smad2 Protein metabolism, Disease Models, Animal, Rats, Sprague-Dawley, Erectile Dysfunction drug therapy, Erectile Dysfunction etiology, Diabetes Mellitus, Experimental complications, Diabetes Mellitus, Experimental drug therapy, Fibrosis, Niclosamide pharmacology, Niclosamide therapeutic use, Signal Transduction drug effects
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Background: Diabetes mellitus-induced erectile dysfunction (DMED) is a common urological complication of diabetes, and current drugs often fail to provide an effective treatment. Smad2/3 signaling-mediated corporal fibrosis has a critical role in the molecular basis of DMED., Aim: We investigated the effect of Niclosamide (Nic), an antihelmintic drug with antifibrotic effects, on erectile function in a rat DMED model., Methods: Male Sprague Dawley rats were injected intraperitoneally (i.p) with streptozotocin (75 mg/kg) to induce diabetes. At week 8, both diabetic and nondiabetic rats were treated with Nic (10 mg·kg-1/day; i.p) or vehicle for 4 weeks. At week 12, erectile function was evaluated as intracavernous pressure (ICP) response to the electrical stimulation of the cavernous nerve (CN). Penile tissues were harvested for Masson's trichrome staining or western blotting to determine corporal fibrosis and Smad2/3 pathway-related protein expression, respectively., Outcomes: At the end of the experimental protocol, in vivo erectile function was assessed by measuring the ratio of ICP/ mean arterial pressure (MAP) and total ICP following CN stimulation. Smooth muscle content and collagen fibers were evaluated by Masson's trichrome staining of the penile tissues. The expressions of fibrosis-related proteins (Smad2, Smad3, fibronectin) were determined using western blotting in the penile tissues., Results: Erectile function, as determined by the maximum ICP/MAP and total ICP/MAP ratios, was drastically decreased in diabetic rats. Corporal tissues of diabetic rats were severely fibrotic with a significant increase in collagen fibers and a marked reduction in smooth muscle content. Also, the protein expressions of phosphorylated (p-)Smad2, p-Smad3 and fibronectin were significantly increased in the penis of diabetic rats. Both functional and molecular alterations in DMED were effectively reversed by Nic-treated diabetic rats without a glycemic alteration., Clinical Implications: Nic could be a promising candidate for the treatment of DMED due to its antifibrotic effects., Strengths and Limitations: The present study provides the first evidence that Nic has beneficial effect on erectile dysfunction by attenuating corporal fibrosis in a rat model of DMED. The effect of Nic on penile endothelial function and the other potential underlying mechanisms needs to be further elucidated., Conclusions: Nic improved erectile function in DMED rats possibly suppressing penile fibrosis by inhibiting Smad2/3 signaling. These results suggest a potential therapeutic repurposing of Nic as an adjuvant treatment in DMED., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2024
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6. Sympathetic hypoactivity leads to hypocontractility of the corpus cavernosum in sickle cell mice: a mechanism contributing to priapism.
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Silveira THR, Pereira DA, Calmasini FB, Costa FF, Burnett AL, and Silva FH
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Priapism, a prevalent complication in sickle cell disease (SCD) patients, manifests as prolonged and painful erections unrelated to sexual arousal. The detailed mechanisms contributing to this condition, especially regarding sympathetic function in the corpus cavernosum that maintains penile flaccidity, remain to be elucidated. In this study, it was hypothesized that the pathways of the sympathetic nervous system would be down-regulated, thereby contributing to the development of ischemic priapism in sickle cell disease. This study aimed to investigate the contractions induced by stimulation of sympathetic terminals and the expression of tyrosine hydroxylase in the corpora cavernosa of Berkeley SCD mice. C57BL/6 mice (wild-type, WT) and Berkeley SCD mice were used. A total of 22 mice were used in this study, with 11 allocated to the WT group and 11 to the SCD group. Mice corpus cavernosum was dissected free and mounted in 7-mL organ baths containing Krebs solution. Noradrenergic contractions were obtained using electrical-field stimulation (4-32 Hz) in corpus cavernosum strips from WT and SCD mice. Measurements of tyrosine hydroxylase phosphorylated at Ser-31 and total tyrosine hydroxylase protein expressions in cavernosal tissues were also measured by western blot. The neurogenic contractions were significantly lower (P < 0.05) in the SCD group compared to WT group at all tested frequencies. The protein expression of both total tyrosine hydroxylase and tyrosine hydroxylase phosphorylated at Ser-31 was significantly decreased by approximately 46.28% (P = 0.01) and 55.32% (P = 0.03) in cavernosal tissues from the SCD group compared to the control group, respectively. In conclusion, sympathetic hypoactivity characterized by the downregulation of tyrosine hydroxylase contributes to the hypocontractility of the corpus cavernosum in Berkeley SCD mice. This suggests an impairment in the mechanism responsible for maintaining penile flaccidity, potentially predisposing to erections without sexual stimulation, similar to those observed in ischemic priapism. Pharmacological treatments aiming to restore sympathetic tone in the penis might hold promise for addressing ischemic priapism in SCD., Competing Interests: Competing interests: The authors declare no competing interests. Ethics approval and consent to participate: All experimental procedures were performed in accordance with the relevant guidelines and regulations. The study was approved by the Ethics Committee on Animal Use of the University of Campinas (CEUA/UNICAMP), under permit number 4754-1/2017. Consent to participate is not applicable., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2024
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7. What is Needed to Support Non-Urban Urology in the United States? Perspectives from Urologists in Rural and Underresourced Areas.
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Kieran K, Granberg C, Deibert C, Burnett AL, and Chung PH
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Introduction: Twenty percent of Americans live in non-urban areas, and the challenges in providing high-quality health care in rural areas are well described. These challenges are further exacerbated by the fact that rural citizens are often older and sicker than their urban colleagues, as well as by the ongoing workforce shortage in urology. This study aims to describe the current practice experiences of non-metropolitan urologists (NMUs) in the United States., Methods: Based on the results of the 2022 American Urological Association Census, a secondary questionnaire was developed and distributed electronically to urologists who self-identified in the Census as practicing in non-metropolitan areas. Multiple choice answers were summarized as proportions and free-text answers were collected and grouped by theme., Results: One hundred and thirteen of 552 (20.5%) urologists responded. Most respondents were male (92.9%), aged >55 years (76.1%), in practice >25 years, and in solo practice (25.5%) or a subspecialty group (20.8%). Stressors for NMUs included recruitment (61.3%), call concerns (59.3%), workforce issues (59.3%), difficulty interacting with tertiary medical centers (45.1%), and lack of resources (40.7%). Nearly half of respondents (48.5%) experience burnout more than once monthly, and 31.9% anticipate continuing their current practice and pace for the next five years. Call burden is the most likely reason to leave practice (40%)., Conclusions: Most urologists practicing in non-metropolitan areas are older, endorse high rates of burnout, and have active plans to leave or decrease practice within five years. Understanding contemporary stressors can inform policies to support current and future NMUs.
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- 2024
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8. Factors Affecting Implant Length in Primary Inflatable Penile Prosthesis Placement.
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Miller JA, Hammad M, Amini E, Andrianne R, Burnett AL, Gross K, Gross MS, Hatzichristodoulou G, Hotaling J, Hsieh TC, Jenkins LC, Jones JM, Lentz A, Levy J, Modgil V, Osmonov D, Park SH, Pearce I, Perito P, Sadeghi-Nejad H, Sempels M, Simhan J, Suarez-Sarmiento A Jr, van Renterghem K, Warner JN, Yafi FA, Ziegelmann M, and Barham DW
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- Humans, Male, Retrospective Studies, Middle Aged, Aged, Erectile Dysfunction surgery, Prostatectomy methods, Penile Prosthesis, Penile Implantation methods, Prosthesis Design
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Objective: To evaluate predictors of implant length for men undergoing primary IPP placement., Methods: A multicenter, retrospective cohort study was performed for men undergoing primary IPP placement at 16 high-volume surgical centers. Patient demographics, comorbidities, operative approach, and implanted cylinder and rear-tip extender length were recorded. Associations between potential preoperative and intraoperative predictors of total device length were tested using non-parametric correlation and Kruskal-Wallis tests, followed by multiple regression., Results: Of 3951 men undergoing primary IPP placement from July 2016 to July 2021, the median implant length was 20 cm (IQR: 19-22). Shorter implant length was associated with increasing age in years (β = -0.01, P = .009), Asian ethnicity (β = -2.34, P = .008), history of radical prostatectomy (β = -0.35, P = .001), and use of an infrapubic surgical approach (β = -1.02, P <.001). Black or African American ethnicity was associated with the implantation of longer devices (β = 0.35, P <.001). No significant associations were recorded with BMI, history of intracavernosal injections, diabetes mellitus, tobacco use, radiation therapy, Peyronie's disease, priapism, or cavernosal dilation technique., Conclusion: The length of an implanted penile prosthesis was found to be associated with preoperative and intraoperative factors including history of radical prostatectomy and operative approach. The knowledge of these associations may assist in the preoperative counseling of patients receiving IPP and help create accurate postoperative expectations., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JAM, MH, EA, KG, GH, JMH, TH, JMJ, VM, SHP, IP, HSN, AS, MS, KVR, NW, DWB - no disclosures; MSG-consultant Coloplast; AL-speaker, consultant, preceptor for Boston Scientific and Coloplast; DO-consultant Coloplast, Intuitive Surgical, Fidelis; PP-consultant Coloplast. Boston Scientific, Urofill; JS-consultant Boston Scientific and Coloplast; FAY- consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma; MZ- consultant Endo Pharma., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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9. Heme-induced corpus cavernosum relaxation and its implications for priapism in sickle cell disease: a mechanistic insight.
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Pereira DA, Pereira DA, Silveira THR, Calmasini FB, Burnett AL, Costa FF, and Silva FH
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- Male, Animals, Mice, Muscle, Smooth metabolism, Muscle, Smooth physiopathology, Soluble Guanylyl Cyclase metabolism, Carbon Monoxide metabolism, Heme Oxygenase (Decyclizing) metabolism, Anemia, Sickle Cell complications, Anemia, Sickle Cell physiopathology, Anemia, Sickle Cell metabolism, Priapism etiology, Priapism physiopathology, Priapism metabolism, Muscle Relaxation drug effects, Penis blood supply, Penis metabolism, Heme metabolism, Cyclic GMP metabolism, Mice, Inbred C57BL
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Background: Patients with sickle cell disease (SCD) experience intravascular hemolysis, leading to elevated plasma heme levels. This phenomenon has been associated with increased priapism in men with SCD. The heme group can be metabolized by heme oxygenase (HO), generating carbon monoxide (CO), which is known to promote smooth muscle relaxation via soluble guanylyl cyclase (sGC)-cyclic guanosine monophosphate (cGMP). However, the effects of heme on the relaxation responses of corpus cavernosum (CC) have not been investigated., Objectives: To evaluate the functional and biochemical effects of the heme group on mouse CC smooth muscle in vitro., Materials and Methods: Male C57BL/6 mice were used. CC tissues were mounted in organ baths. Measurement of cGMP in mice CC was evaluated., Results: The cumulative addition of heme concentrations promoted the relaxation of CC. HO inhibitor (1J, 100 μM) or sGC inhibitor (ODQ, 10 μM) blocked the relaxing effect of the heme group. Pre-incubation of CC with heme (100 μM) enhanced relaxation induced by acetylcholine, sodium nitroprusside, and nitrergic relaxation (electrical field stimulation), which was abolished by 1J or ODQ. The heme group increased the cGMP production in CC, which was abolished by 1J or ODQ. cGMP levels were significantly higher in CC treated with heme, and pre-incubation with compound 1J or ODQ abolished the effect of heme in raising cGMP levels., Discussion and Conclusion: The HO-CO-sGC-cGMP pathway appears to play a crucial role in promoting CC relaxation. Our study provides novel insight into the role of group heme in CC relaxation and its potential contribution to priapism in SCD. Heme may serve as a pharmacological target for new therapies to prevent priapism., (© 2024 American Society of Andrology and European Academy of Andrology.)
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- 2024
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10. Characterizing patient experiences with repeat artificial urinary sphincter revisions through quantitative surveys and qualitative patient interviews.
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Huffman PJ, Ewachiw G, Johnson R, Huang MM, Dani H, Knijnik PG, da Silva AF, Burnett AL, Mostwin JL, Wright EJ, and Cohen AJ
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Background: Artificial urinary sphincter (AUS) placement remains the gold-standard treatment for post-prostatectomy urinary incontinence (PPUI), despite their need for periodic surgical revision., Objective: To understand the experiences of patients who undergo repeat AUS revisions., Design: Mixed design including quantitative surveys and qualitative interviews for thematic analysis., Methods: Men with ⩾2 revisions were collected from a single-institution, retrospective database of AUS patients. Participants were interviewed about their prostatectomy, incontinence, AUS placement, and revisions. A survey was administered utilizing validated tools (e.g., Decision Regret Scale (DRS), Incontinence Impact Questionnaire-7) for quantitative analysis. Interview transcripts were used for qualitative thematic analysis., Results: Of 26 respondents, 20 completed the interview. Twenty-three men completed the survey. The mean DRS score for prostatectomy was 24 (standard deviation (SD) = 27), indicating low regret. Median Incontinence Impact Questionnaire score was 54 (SD = 27), with 70% of participants describing their PPUI as "severe." Participants experienced a significant decrease in daily pad usage with AUS placement (5.5 pre-AUS vs 1.4 post-AUS, p < 0.0001). Qualitative analysis revealed themes involving prostatectomy urgency, physician-patient relationships, expectation setting, and quality of follow-up. Most participants (96%) were satisfied with their initial AUS placement and endorsed a positive relationship with their urologist. However, 22% of participants were unaware of device limitations, including the need for revision. Some participants (26%) were uncertain of the status of their AUS, while some participants (35%) desired improved follow-up., Conclusions: Initial improvement and positive experiences with urologists motivate patients to undergo AUS repeat revision. Urologists should emphasize the limitations of the AUS before placement and follow up with patients to evaluate their needs for future care., Competing Interests: The authors declare that there is no conflict of interest., (© The Author(s), 2024.)
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- 2024
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11. Proceedings of PRINCETON IV: PDE5 inhibitors and cardiac health symposium.
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Rosen RC, Miner M, Burnett AL, Blaha MJ, Ganz P, Goldstein I, Kim N, Kohler T, Lue T, McVary K, Mulhall J, Parish SJ, Sadeghi-Nejad H, Sadovsky R, Sharlip I, and Kloner RA
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- Humans, Male, Cardiovascular Diseases, Erectile Dysfunction drug therapy, Phosphodiesterase 5 Inhibitors adverse effects, Phosphodiesterase 5 Inhibitors therapeutic use
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Introduction: Prior consensus meetings have addressed the relationship between phosphodiesterase type 5 (PDE5) inhibition and cardiac health. Given significant accumulation of new data in the past decade, a fourth consensus conference on this topic was convened in Pasadena, California, on March 10 and 11, 2023., Objectives: Our meeting aimed to update existing knowledge, assess current guidelines, and make recommendations for future research and practice in this area., Methods: An expert panel reviewed existing research and clinical practice guidelines., Results: Key findings and clinical recommendations are the following: First, erectile dysfunction (ED) is a risk marker and enhancer for cardiovascular (CV) disease. For men with ED and intermediate levels of CV risk, coronary artery calcium (CAC) computed tomography should be considered in addition to previous management algorithms. Second, sexual activity is generally safe for men with ED, although stress testing should still be considered for men with reduced exercise tolerance or ischemia. Third, the safety of PDE5 inhibitor use with concomitant medications was reviewed in depth, particularly concomitant use with nitrates or alpha-blockers. With rare exceptions, PDE5 inhibitors can be safely used in men being treated for hypertension, lower urinary tract symptoms and other common male disorders. Fourth, for men unresponsive to oral therapy or with absolute contraindications for PDE5 inhibitor administration, multiple treatment options can be selected. These were reviewed in depth with clinical recommendations. Fifth, evidence from retrospective studies points strongly toward cardioprotective effects of chronic PDE5-inhibitor use in men. Decreased rates of adverse cardiac outcomes in men taking PDE-5 inhibitors has been consistently reported from multiple studies. Sixth, recommendations were made regarding over-the-counter access and potential risks of dietary supplement adulteration. Seventh, although limited data exist in women, PDE5 inhibitors are generally safe and are being tested for use in multiple new indications., Conclusion: Studies support the overall cardiovascular safety of the PDE5 inhibitors. New indications and applications were reviewed in depth., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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12. The Princeton IV Consensus Recommendations for the Management of Erectile Dysfunction and Cardiovascular Disease.
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Köhler TS, Kloner RA, Rosen RC, Burnett AL, Blaha MJ, Ganz P, Goldstein I, Kim NN, Lue T, McVary KT, Mulhall JP, Parish SJ, Sadeghi-Nejad H, Sadovsky R, Sharlip ID, and Miner M
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- Humans, Male, Consensus, Erectile Dysfunction drug therapy, Erectile Dysfunction therapy, Erectile Dysfunction etiology, Erectile Dysfunction diagnosis, Cardiovascular Diseases, Phosphodiesterase 5 Inhibitors therapeutic use
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The Princeton Consensus (Expert Panel) Conference is a multispecialty collaborative symposium dedicated to optimizing sexual function and preserving cardiovascular health. The Fourth Princeton Consensus Conference was convened on March 10-11, 2023, at the Huntington Medical Research Institutes in Pasadena, California. Princeton panels I to III addressed the clinical management of men with erectile dysfunction (ED) who also had cardiovascular disease. Thirteen years since Princeton III, Princeton IV builds on previous foundations in several key areas. Mounting evidence supports the need for providers to treat men with ED as being at risk for cardiac events until proven otherwise. Algorithms for the diagnosis and treatment of ED are updated with new recommendations for coronary artery calcium scoring for advanced cardiovascular risk stratification. Optimization of oral phosphodiesterase type 5 inhibitors in the treatment of men with ED and cardiovascular disease is thoroughly explored, including recent evidence of potential cardioprotective effects of these drugs., (Copyright © 2024 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)
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- 2024
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13. Quest for a genetic biomarker for sickle cell disease priapism: rationale, progress and implications.
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Adesanya O and Burnett AL
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- 2024
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14. Early-onset and uncontrolled diabetes mellitus factors correlate with complications of Peyronie's disease.
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Karakus S, Unal S, Dai D, Joseph C, Du Comb W, Levy JA, Hawksworth D, and Burnett AL
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- Humans, Male, Middle Aged, Retrospective Studies, Aged, Age of Onset, Adult, Disease Progression, Penis diagnostic imaging, Risk Factors, Penile Induration complications, Diabetes Mellitus, Type 2 complications, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism
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Background: Peyronie's disease (PD) is a connective tissue disorder that affects the penis and is characterized by abnormal collagen structure in the penile tunica albuginea, resulting in plaque formation and penile deformity. PD's overall prevalence is estimated at 3.2% to 8.9%, with rates as high as 20.3% among men with type 2 diabetes mellitus (DM). However, the characteristics of DM associated with PD complications remain unclear., Aim: To explore clinical associations between DM characteristics and PD complications., Methods: We conducted a retrospective analysis of patients with DM and PD who presented at our institution between 2007 and 2022. We examined patients' clinical histories, DM- and PD-related clinical parameters, and complications. Penile deformities were assessed through physical examination, photographs, and penile Doppler ultrasound. Patients were categorized into subgroups based on age of DM onset: early (<45 years), average (45-65 years), and late (>65 years)., Outcomes: Outcomes included effects of DM characteristics on PD development, progression, and severity., Results: In total, 197 patients were included in the evaluation. Early-onset diabetes and elevated hemoglobin A1c (HbA1c) levels exhibited significant correlations with the early development of PD (ρ = 0.66, P < .001, and ρ = -0.24, P < .001, respectively). Furthermore, having DM at an early age was associated with the occurrence of penile plaque (ρ = -0.18, P = .03), and there were no significant differences in plaque dimensions (ρ = -0.29, P = .053). A rise in HbA1c levels after the initial PD diagnosis displayed positive correlations with the formation of penile plaque (ρ = 0.22, P < .006)., Clinical Implications: These findings emphasize the need for comprehensive assessments and personalized treatment strategies for individuals with DM and PD. Enhanced management approaches can improve outcomes for those facing both challenges., Strengths and Limitations: Limitations include the single-site retrospective design with potential selection bias, inaccuracies in medical record data, and challenges in controlling confounding variables., Conclusions: This study highlights that early-onset diabetes and poor diabetes control, as indicated by a subsequent rise in HbA1c levels following PD diagnosis, are significantly correlated with the onset and severity of PD. Revealing the mechanisms behind these findings will help us develop better management strategies for individuals with DM and PD., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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15. Clinical outcomes of the Burnett "snake" maneuver shunt modification for ischemic priapism.
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Unal S, Karakus S, Du Comb W, and Burnett AL
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- Humans, Male, Retrospective Studies, Adult, Middle Aged, Treatment Outcome, Penile Erection physiology, Priapism surgery, Priapism etiology, Penis blood supply, Penis surgery, Ischemia surgery
- Abstract
Background: Major ischemic priapism (IP) is defined as a persistent penile erection for >4 hours. IP may cause serious complications, especially if prompt resolution is not achieved. Therefore, selecting the most effective and usable shunt technique is crucial in IP cases that are refractory to medical therapy., Aim: To compare the effectiveness and complication risks of distal corporoglanular shunt procedures with and without the Burnett "snake" maneuver., Methods: We conducted a retrospective study of patients who presented with IP and underwent surgical treatment at our institution between 2005 and 2021. The patients were categorized into 2 groups: group 1 (n = 26) underwent distal shunt + Burnett snake maneuver, and group 2 (n = 56) underwent distal shunt-only. Clinical history, parameters of IP, details of medical and surgical treatments, and follow-up information were evaluated., Outcomes: Outcomes included differences in IP resolution and recurrence, functional erections, and complications between corporoglanular shunt procedures with and without the Burnett snake maneuver., Results: In group 1, 24 of 26 patients (92.3%) experienced priapism resolution with a single surgical intervention, while this outcome was observed in 30 of 56 patients (53.6%) in group 2 (P < .001). Notably, priapism recurrence was significantly lower in group 1, occurring in 1 of 24 patients (4.2%), as opposed to 8 of 30 patients (26.6%) in group 2 (P < .001). Of the patients with documented sexual function status at follow-up, functional erections (capable of penetration with or without phosphodiesterase 5 inhibitors) were noted in 6 of 14 patients (42.8%) in group 1 and 13 of 26 patients (50%) in group 2 (P = .66)., Clinical Implications: This study provides valuable insights regarding technical aspects of distal shunt procedures with and without the Burnett snake maneuver for treating major IP episodes. These results can help surgeons with clinical decision making for patients who present with IP., Strength and Limitations: Limitations include the single-site retrospective design with potential selection bias, inaccuracies in medical record data, challenges in controlling confounding variables, and the lack of validated questionnaire scores for erectile function evaluation., Conclusion: Our study demonstrates that modifying distal shunt procedures using the Burnett snake maneuver significantly improves priapism resolution and effectively prevents further priapism episodes without introducing additional complications or erectile function loss, thereby distinguishing it from distal shunt-only procedures., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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16. Impact of intravascular hemolysis on functional and molecular alterations in the urinary bladder: implications for an overactive bladder in sickle cell disease.
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Silveira THRE, Pereira DA, Pereira DA, Calmasini FB, Burnett AL, Costa FF, and Silva FH
- Abstract
Patients with sickle cell disease (SCD) display an overactive bladder (OAB). Intravascular hemolysis in SCD is associated with various severe SCD complications. However, no experimental studies have evaluated the effect of intravascular hemolysis on bladder function. This study aimed to assess the effects of intravascular hemolysis on the micturition process and the contractile mechanisms of the detrusor smooth muscle (DSM) in a mouse model with phenylhydrazine (PHZ)-induced hemolysis; furthermore, it aimed to investigate the role of intravascular hemolysis in the dysfunction of nitric oxide (NO) signaling and in increasing oxidative stress in the bladder. Mice underwent a void spot assay, and DSM contractions were evaluated in organ baths. The PHZ group exhibited increased urinary frequency and increased void volumes. DSM contractile responses to carbachol, KCl, α-β-methylene-ATP, and EFS were increased in the PHZ group. Protein expression of phosphorylated endothelial NO synthase (eNOS) (Ser-1177), phosphorylated neuronal NO synthase (nNOS) (Ser-1417), and phosphorylated vasodilator-stimulated phosphoprotein (VASP) (Ser-239) decreased in the bladder of the PHZ group. Protein expression of oxidative stress markers, NOX-2, 3-NT, and 4-HNE, increased in the bladder of the PHZ group. Our study shows that intravascular hemolysis promotes voiding dysfunction correlated with alterations in the NO signaling pathway in the bladder, as evidenced by reduced levels of p-eNOS (Ser-1177), nNOS (Ser-1417), and p-VASP (Ser-239). The study also showed that intravascular hemolysis increases oxidative stress in the bladder. Our study indicates that intravascular hemolysis promotes an OAB phenotype similar to those observed in patients and mice with SCD., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Silveira, Pereira, Pereira, Calmasini, Burnett, Costa and Silva.)
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- 2024
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17. Nitric Oxide Resistance in Priapism Associated with Sickle Cell Disease: Mechanisms, Therapeutic Challenges, and Future Directions.
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Pereira DA, Calmasini FB, Costa FF, Burnett AL, and Silva FH
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- Humans, Male, Animals, Cyclic GMP metabolism, Phosphodiesterase 5 Inhibitors therapeutic use, Phosphodiesterase 5 Inhibitors pharmacology, Priapism etiology, Priapism drug therapy, Priapism metabolism, Anemia, Sickle Cell drug therapy, Anemia, Sickle Cell complications, Anemia, Sickle Cell metabolism, Nitric Oxide metabolism, Cyclic Nucleotide Phosphodiesterases, Type 5 metabolism
- Abstract
Patients with sickle cell disease (SCD) display priapism, a prolonged penile erection in the absence of sexual arousal. The current pharmacological treatments for SCD-associated priapism are limited and focused on acute interventions rather than prevention. Thus, there is an urgent need for new drug targets and preventive pharmacological therapies for this condition. This review focuses on the molecular mechanisms linked to the dysfunction of the NO-cyclic guanosine monophosphate (cGMP)-phosphodiesterase type 5 (PDE5) pathway implicated in SCD-associated priapism. In murine models of SCD, reduced nitric oxide (NO)-cGMP bioavailability in the corpus cavernosum is associated with elevated plasma hemoglobin levels, increased reactive oxygen species levels that inactive NO, and testosterone deficiency that leads to endothelial nitric oxide synthase downregulation. We discuss the consequences of the reduced cGMP-dependent PDE5 activity in response to these molecular changes, highlighting it as the primary pathophysiological mechanism leading to excessive corpus cavernosum relaxation, culminating in priapism. We also further discuss the impact of intravascular hemolysis on therapeutic approaches, present current pharmacological strategies targeting the NO-cGMP-PDE5 pathway in the penis, and identify potential pharmacological targets for future priapism therapies. In men with SCD and priapism, PDE5 inhibitor therapy and testosterone replacement have shown promising results. Recent preclinical research reported the beneficial effect of treatment with haptoglobin and NO donors. SIGNIFICANCE STATEMENT: This review discusses the molecular changes that reduce NO-cGMP bioavailability in the penis in SCD and highlights pharmacological targets and therapeutic strategies for the treatment of priapism, including PDE5 inhibitors, hormonal modulators, NO donors, hydroxyurea, soluble guanylate cyclase stimulators, haptoglobin, hemopexin, and antioxidants., (Copyright © 2024 by The American Society for Pharmacology and Experimental Therapeutics.)
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- 2024
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18. Nitric oxide in the penis: still the key erection player?
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Burnett AL
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- Humans, Male, Erectile Dysfunction drug therapy, Erectile Dysfunction physiopathology, Nitric Oxide metabolism, Nitric Oxide physiology, Penis, Penile Erection physiology
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- 2024
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19. Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.
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Barham DW, Pyrgidis N, Amini E, Hammad M, Miller J, Andrianne R, Burnett AL, Gross K, Hatzichristodoulou G, Hotaling J, Hsieh TC, Jenkins LC, Jones JM, Lentz A, Modgil V, Osmonov D, Park SH, Pearce I, Perito P, Sadeghi-Nejad H, Sempels M, Suarez-Sarmiento A, Simhan J, van Renterghem K, Warner JN, Ziegelmann M, Yafi FA, and Gross MS
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- Humans, Male, Middle Aged, Retrospective Studies, Aged, Seasons, Temperature, Penile Implantation adverse effects, Climate, Risk Factors, Penile Prosthesis adverse effects, Prosthesis-Related Infections epidemiology, Prosthesis-Related Infections etiology
- Abstract
Background: Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections., Aim: We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort., Methods: We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken., Outcomes: Our primary outcome was implant infection., Results: A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection., Clinical Implications: These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate., Strengths and Limitations: Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed., Conclusion: The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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20. Erectile dysfunction and Peyronie's disease diagnosis rates after penile fracture-a retrospective claims database cohort analysis.
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Maremanda AP, Du Comb W, Able C, Kohn TP, Unal S, and Burnett AL
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- Male, Humans, Middle Aged, Retrospective Studies, Cyclic Nucleotide Phosphodiesterases, Type 5, Penile Erection, Phosphodiesterase 5 Inhibitors therapeutic use, Erectile Dysfunction diagnosis, Erectile Dysfunction epidemiology, Erectile Dysfunction complications, Penile Induration complications, Penile Induration diagnosis, Penile Induration epidemiology
- Abstract
Our objective was to analyze the rates of erectile dysfunction and Peyronie's disease following a penile fracture using a large, multi-institutional claims database. Inclusion criteria included men ages 15 or older with a diagnosis of penile fracture and any office visit within 5 years of the penile fracture. Exclusion criteria included prior erectile dysfunction, prescription of erectile aids, or penile prosthesis placement. Our primary outcome was the diagnosis of erectile dysfunction or prescription of phosphodiesterase-5 inhibitors within 5 years. A secondary analysis assessed rates of Peyronie's disease following penile fracture. 1242 men were identified with penile fracture and subsequently matched to men without penile fracture, resulting in equal cohorts of 1227 men. Men with a history of penile fracture were more likely to receive a diagnosis of erectile dysfunction or require phosphodiesterase-5 inhibitors (RR 3.18, 95% CI: 2.30-4.40). Men who did not undergo immediate repair had higher rates of erectile dysfunction or treatment (RR: 1.84, 95% CI: 1.22-2.78). Men over the age of 45 years who had a penile fracture were more likely to develop erectile dysfunction or treatment compared to men under 45 years (RR: 1.65, 95% CI: 1.14-2.39). Rates of Peyronie's disease were higher in men with a history of penile fracture (5.8% vs 0%, p < 0.0001). Rates of Peyronie's disease were lower if immediate repair of the fracture was performed (RR: 0.20, 95% CI: 0.10-0.41). Men over the age of 45 years with penile fracture were more likely to develop Peyronie's Disease within 5 years compared to men under the age of 45 years penile fracture (RR: 3.72, 95% CI: 1.94-7.16). Penile fracture increases the risk of both erectile dysfunction and Peyronie's disease, especially those treated with conservative measures or over the age of 45 years compared to patients under 45 years with a penile fracture., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2024
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21. Racial and socioeconomic disparities in surgical care for post-prostate cancer treatment complications: A nationwide Medicare-based analysis.
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Adesanya O, Rojanasarot S, McGovern AM, and Burnett AL
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Objectives: To investigate the racial and socioeconomic (income) differences in receipt of and time to surgical care for urinary incontinence (UI) and erectile dysfunction (ED) occurring post-radical prostatectomy (RP) and/or radiation therapy (RT)., Materials and Methods: Utilizing the Medicare Standard Analytical Files (SAF), a retrospective cohort study was performed on data of patients diagnosed with prostate cancer (PCa) from 2015 to 2021. Patients who underwent RP and/or RT and who subsequently developed UI and/or ED were grouped into four cohorts: RP-ED, RP-UI, RT-ED and RT-UI. County-level median household income was cross-referenced with SAF county codes, classified into income quartiles, and used as a proxy for patient income status. The rate of surgical care was compared between groups using two-sample t-test and log-rank test. Cox proportional hazards modelling was used to determine covariate-adjusted impact of race on time to surgical care., Results: The rate of surgical care was 6.8, 3.61 3.07, and 1.54 per 100 person-years for the RP-UI, RT-UI, RP-ED, and RT-ED cohorts, respectively. Cox proportional 'time-to-surgical care' regression analysis revealed that Black men were statistically more likely to receive ED surgical care (RP-ED AHR:1.79, 95% CI:1.49-2.17; RT-ED AHR:1.50, 95% CI:1.11-2.01), but less likely to receive UI surgical care (RP-UI AHR:0.80, 95% CI:0.67-0.96) than White men, in all cohorts except RT-UI. Surgical care was highest among Q1 (lowest income quartile) patients in all cohorts except RT-UI., Conclusions: Surgical care for post-PCa treatment complications is low, and significantly impacted by racial and socioeconomic (income) differences. Prospective studies investigating the basis of these results would be insightful., Competing Interests: Support for this research was provided by Boston Scientific, Marlborough, MA. Sirikan Rojanasarot and Alysha McGovern are full‐time employees of Boston Scientific. Oluwafolajimi Adesanya has no conflicts of interest to disclose. Arthur Burnett is a research award recipient from Boston Scientific. Oluwafolajimi Adesanya and Arthur Burnett were not compensated for their participation in this study., (© 2024 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)
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- 2024
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22. Priapism: a new era.
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Burnett AL
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- Humans, Male, Penis, Priapism etiology, Priapism therapy
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- 2024
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23. Princeton IV consensus guidelines: PDE5 inhibitors and cardiac health.
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Kloner RA, Burnett AL, Miner M, Blaha MJ, Ganz P, Goldstein I, Kim NN, Kohler T, Lue T, McVary KT, Mulhall JP, Parish SJ, Sadeghi-Nejad H, Sadovsky R, Sharlip ID, and Rosen RC
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- Male, Humans, Female, Phosphodiesterase 5 Inhibitors adverse effects, Erectile Dysfunction, Cardiovascular Diseases drug therapy
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Background: In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug-drug interactions, but also a potential cardioprotective effect of these drugs., Aim: In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease., Method: A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus., Outcomes: Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors., Results: An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug-drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non-PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non-PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed., Clinical Implications: Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease., Strengths and Limitations: Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting., Conclusion: The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine.)
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- 2024
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24. Arthur L. "Bud" Burnett, MD, MBA.
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Bud Burnett AL
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- 2023
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25. Cavernous nerve mapping methods for radical prostatectomy.
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Unal S, Musicki B, and Burnett AL
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- Male, Humans, Quality of Life, Penile Erection physiology, Prostatectomy adverse effects, Prostate surgery, Erectile Dysfunction etiology
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Introduction: Preserving the cavernous nerves, the main autonomic nerve supply of the penis, is a major challenge of radical prostatectomy. Cavernous nerve injury during radical prostatectomy predominantly accounts for post-radical prostatectomy erectile dysfunction. The cavernous nerve is a bilateral structure that branches in a weblike distribution over the prostate surface and varies anatomically in individuals, such that standard nerve-sparing methods do not sufficiently sustain penile erection ability. As a consequence, researchers have focused on developing personalized cavernous nerve mapping methods applied to the surgical procedure aiming to improve postoperative sexual function outcomes., Objectives: We provide an updated overview of preclinical and clinical data of cavernous nerve mapping methods, emphasizing their strengths, limitations, and future directions., Methods: A literature review was performed via Scopus, PubMed, and Google Scholar for studies that describe cavernous nerve mapping/localization., Results: Several cavernous nerve mapping methods have been investigated based on various properties of the nerve structures including stimulation techniques, spectroscopy/imaging techniques, and assorted combinations of these methods. More recent methods have portrayed the course of the main cavernous nerve as well as its branches based on real-time mapping, high-resolution imaging, and functional imaging. However, each of these methods has distinctive limitations, including low spatial accuracy, lack of standardization for stimulation and response measurement, superficial imaging depth, toxicity risk, and lack of suitability for intraoperative use., Conclusion: While various cavernous nerve mapping methods have provided improvements in identification and preservation of the cavernous nerve during radical prostatectomy, no method has been implemented in clinical practice due to their distinctive limitations. To overcome the limitations of existing cavernous nerve mapping methods, the development of new imaging techniques and mapping methods is in progress. There is a need for further research in this area to improve sexual function outcomes and quality of life after radical prostatectomy., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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26. Lessons learned from the first 15 years of penile transplantation and updates to the Baltimore Criteria.
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Lopez CD, Girard AO, Lake IV, Oh BC, Brandacher G, Cooney DS, Burnett AL, and Redett RJ
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- Male, Humans, Baltimore, Tissue Donors, Penis surgery, Penile Transplantation, Tacrolimus
- Abstract
Since 2006, five penis transplants have been performed worldwide. Mixed outcomes have been reported, and two of the five penile transplants have required explantation. However, the long-term outcomes have been encouraging when compliance is implemented, whether standard induction and triple therapy maintenance, or single therapy maintenance. Follow-up monitoring of transplant recipients has enabled a synthesis of technical considerations for surgical success and has shown stable leukocyte counts and renal function after a donor bone-marrow-based immunomodulatory regimen followed by tacrolimus monotherapy as long as 3 years post-transplant, as well as continuous nerve regeneration of penile allografts 3 years post-transplant. Areas of uncertainty include the ethics of donor-recipient colour mismatch, surveillance for sexually transmitted infections and how to optimize patient compliance. Questions also remain with respect to the long-term immunological sequelae of penile tissue, functional outcomes, psychosocial implications and patient selection. Patient counselling should be modified to mention the possibility of long-term improvement in nerve regeneration and sufficient renal function with single-therapy maintenance, and to build a longitudinal dialogue and partnership between the patient and the multidisciplinary care team regarding the risks of sexually transmitted infection instead of surveillance., (© 2023. Springer Nature Limited.)
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- 2023
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27. Disparities in prostate cancer.
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Burnett AL, Nyame YA, and Mitchell E
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- Humans, Male, Delivery of Health Care, Educational Status, Health Status Disparities, Healthcare Disparities, Black or African American, Prostatic Neoplasms diagnosis, Prostatic Neoplasms therapy
- Abstract
Despite substantial advances in early detection/prevention and treatments, and improved outcomes in recent decades, prostate cancer continues to disproportionately affect Black men and is the secondleading cause of cancer death in this subgroup. Black men are substantially more likely to develop prostate cancer and are twice as likely to die from the disease compared with White men. In addition, Black men are younger at diagnosis and face a higher risk of aggressive disease relative to White men. Striking racial disparities endure along the continuum of prostate cancer care, including screening, genomic testing, diagnostic procedures, and treatment modalities. The underlying causes of these inequalities are complex and multifactorial and involve biological factors, structural determinants of equity (i.e., public policy, structural and systemic racism, economic policy), social determinants of health (including income, education, and insurance status, neighborhood/physical environment, community/social context, and geography), and health care factors. The objective of this article is to review the sources of racial disparities in prostate cancer and to propose actionable recommendations to help address these inequities and narrow the racial gap., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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28. Urethral bulking with native tissue during artificial urinary sphincter surgery.
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Rabinowitz MJ, Liu JL, Levy JA, DuComb W, and Burnett AL
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- Humans, Urethra surgery, Retrospective Studies, Urinary Sphincter, Artificial adverse effects, Urinary Incontinence, Stress surgery, Urinary Incontinence, Stress etiology
- Abstract
The artificial urinary sphincter (AUS) is the "gold standard" surgical treatment for severe stress urinary incontinence. However, a subset of patients with frail urethras may require technical adjuncts to ensure optimal cuff function. Our objective is to provide a detailed tutorial of our institution's method for performing urethral bulking with native tissue in patients with frail urethras during AUS surgery. We have found that urethral bulking with native tissue provides a cost-efficient and durable technique for improved AUS cuff coaptation. Our experience demonstrates adequate short and intermediate term efficacy with limited complications. These techniques equip surgeons with an alternative surgical approach for appropriate patients receiving AUS surgery who have been previously exposed to pelvic radiation and/or significant surgical morbidity resulting in frail urethral tissue.
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- 2023
29. AUA-recommended Antibiotic Prophylaxis for Primary Penile Implantation Results in a Higher, Not Lower, Risk for Postoperative Infection: A Multicenter Analysis.
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Barham DW, Pyrgidis N, Gross MS, Hammad M, Swerdloff D, Miller J, Alkhayal A, Alrabeeah KA, Andrianne R, Burnett AL, Gross K, Hatzichristodoulou G, Hotaling JM, Hsieh TC, Jones A, Jones JM, Lentz A, Levy J, Modgil V, Osmonov D, Park SH, Pearce I, Perito P, Sadeghi-Nejad H, Sempels M, Suarez-Sarmiento A Jr, Simhan J, van Renterghem K, Warner JN, Ziegelmann M, and Yafi FA
- Subjects
- Male, Humans, Antibiotic Prophylaxis, Vancomycin therapeutic use, Retrospective Studies, Prospective Studies, Postoperative Complications surgery, Gentamicins therapeutic use, Multicenter Studies as Topic, Penile Implantation, Penile Prosthesis adverse effects, Erectile Dysfunction surgery
- Abstract
Purpose: Our aim was to determine if the AUA-recommended prophylaxis (vancomycin + gentamicin alone) for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard regimens., Materials and Methods: We performed a multicenter, retrospective study of patients undergoing primary inflatable penile prosthesis surgery. Patients were divided into those receiving vancomycin + gentamicin alone and those receiving any other regimen. A Cox proportional-hazards model was constructed adjusted for major predictors. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed., Results: A total of 4,161 patients underwent primary inflatable penile prosthesis placement (2,411 received vancomycin + gentamicin alone and 1,750 received other regimens). The infection rate was similar between groups, 1% vs 1.2% for standard vs nonstandard prophylaxis. In the multivariable analysis, vancomycin + gentamicin (HR: 2.7, 95% CI: 1.4 to 5.4, P = .004) and diabetes (HR: 1.9, 95% CI: 1.03 to 3.4, P = .04) were significantly associated with a higher risk of infection. Antifungals (HR: 0.08, 95% CI: 0.03 to 0.19, P < .001) were associated with lower risk of infection. There was no statistically significant difference in infection rate between weight-based gentamicin compared to 80 mg gentamicin (HR: 2.9, 95% CI: 0.83 to 10, P = .1)., Conclusions: Vancomycin + gentamicin alone for antibiotic prophylaxis for primary inflatable penile prosthesis surgery is associated with a higher infection risk than nonstandard antibiotic regimens while antifungal use is associated with lower infection risk. A critical review of the recommended antimicrobial prophylactic regimens is needed. Prospective research is needed to further elucidate best practices in inflatable penile prosthesis antimicrobial prophylaxis.
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- 2023
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30. Testosterone replacement in prostate cancer survivors with testosterone deficiency: Study protocol of a randomized controlled trial.
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Valderrábano RJ, Pencina K, Storer TW, Reid KF, Kibel AS, Burnett AL, Huang G, Dorff T, Privat F, Ghattas-Puylara C, Wilson L, Latham NK, Holmberg M, and Bhasin S
- Subjects
- Male, Humans, Quality of Life, Prostate-Specific Antigen, Testosterone therapeutic use, Treatment Outcome, Randomized Controlled Trials as Topic, Cancer Survivors, COVID-19, Prostatic Neoplasms drug therapy, Prostatic Neoplasms surgery, Prostatic Neoplasms pathology
- Abstract
Background: Most men diagnosed with prostate cancer today have organ-confined disease and low risk of disease recurrence after radical prostatectomy. Testosterone deficiency in prostate cancer survivors contributes to impaired health-related quality of life but testosterone treatment is viewed as a contraindication in this population., Objectives: We describe the design of the first randomized trial to determine the safety and efficacy of testosterone treatment in men who have undergone prostatectomy for non-aggressive prostate cancer and have symptomatic testosterone deficiency., Methods: Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial is a randomized, placebo-controlled, double-blind, parallel group trial in 142 men, ≥ 40 years, who have undergone radical prostatectomy for organ-confined prostate cancer, Gleason score ≤ 7 (3+4), Stage pT2, N0, M0 lesions and have symptomatic testosterone deficiency and undetectable prostate specific antigen for > 2 years after surgery. Eligible participants are randomized to weekly intramuscular injections of 100-mg testosterone cypionate or placebo for 12 weeks and followed for another 12 weeks. Primary endpoint is change from baseline in sexual activity. Secondary outcomes include change in sexual desire, erectile function, energy, lean and fat mass, physical and cognitive performance. Safety is assessed by monitoring prostate-specific antigen, lower urinary tract symptoms, hemoglobin, and adverse events., Results: The trial is being conducted at two trial sites in Boston, MA and Baltimore, MD. As of July 30, 2022, 42 participants have been randomized. No prostate-specific antigen or clinical recurrence has been noted to-date., Discussion: Recruitment was slowed by coronavirus disease 2019-related closures, slow subsequent ramp-up of research activities, and patient concerns about safety of testosterone treatment. Despite these challenges, participant retention has been high., Conclusion: The Surviving Prostate cancer while Improving quality of life through Rehabilitation with Testosterone Trial, a placebo-controlled, randomized trial, will determine whether testosterone replacement therapy is safe and efficacious in correcting symptoms of testosterone deficiency in prostate cancer survivors, and potentially inform clinical practice., (© 2022 American Society of Andrology and European Academy of Andrology.)
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- 2023
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31. Epidemiology and treatment of priapism in sickle cell disease.
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Idris IM, Burnett AL, and DeBaun MR
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- Adult, Male, Humans, Sildenafil Citrate therapeutic use, Hemolysis, Clinical Trials, Phase II as Topic, Randomized Controlled Trials as Topic, Priapism epidemiology, Priapism etiology, Priapism therapy, Anemia, Sickle Cell complications, Anemia, Sickle Cell epidemiology, Anemia, Sickle Cell therapy, Etilefrine therapeutic use
- Abstract
Ischemic priapism is a common but underrecognized morbidity affecting about 33% of adult men with sickle cell disease (SCD). The onset of priapism occurs in the prepubertal period and tends to be recurrent with increasing age. Significantly, priapism is associated with an unrecognized high burden of mental duress and sexual dysfunctions. The diagnosis of priapism is clinical. Many episodes of priapism will resolve spontaneously, but when an episode lasts longer than 4 hours, the episode is considered a urologic emergency requiring quick intervention with either corporal aspiration or shunt surgery. Only 3 randomized clinical trials (stilbesterol, ephedrine or etilefrine, and sildenafil) have been conducted for secondary priapism prevention in SCD. All 3 trials were limited with small sample sizes, selection biases, and inconclusive results after completion. The current molecular understanding of the pathobiology of priapism suggests a relative nitric oxide (NO) deficiency secondary to chronic hemolysis in SCD and associated phosphodiesterase type 5 dysregulation. We posit an increase in NO levels will restore the normal homeostatic relationship between voluntary erection and detumescence. Currently, 2 randomized phase 2 trials (1 double-blind, placebo-controlled trial and 1 open-label, single-arm intervention) are being conducted for secondary priapism prevention in men at high risk for recurrent priapism (NCT03938454 and NCT05142254). We review the epidemiology and pathobiology of priapism, along with mechanistic therapeutic approaches for secondary prevention of priapism in SCD., (Copyright © 2022 by The American Society of Hematology.)
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- 2022
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32. Characterization of CPH:SA microparticle-based delivery of interleukin-1 alpha for cancer immunotherapy.
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Hasibuzzaman MM, He R, Khan IN, Sabharwal R, Salem AK, and Simons-Burnett AL
- Abstract
Background: Interleukin-1 alpha (IL-1α) is a pro-inflammatory cytokine that can activate immune effector cells and trigger anti-tumor immune responses. However, dose-limiting toxicities including cytokine storm and hypotension has limited its use in the clinic as a cancer therapy. We propose that polymeric microparticle (MP)-based delivery of IL-1α will suppress the acute pro-inflammatory side effects by allowing for slow and controlled release of IL-1α systemically, while simultaneously triggering an anti-tumor immune response., Methods: Polyanhydride copolymers composed of 1,6-bis-(p-carboxyphenoxy)-hexane:sebacic 20:80 (CPH:SA 20:80) was utilized to fabricate MPs. Recombinant IL-1α (rIL-1α) was encapsulated into CPH:SA 20:80 MPs (IL-1α-MPs) and the MPs were characterized by size, charge, loading efficiency, and in-vitro release and activity of IL-1α. IL-1α-MPs were injected intraperitonially into head and neck squamous cell carcinoma (HNSCC)-bearing C57Bl/6 mice and monitored for changes in weight, tumor growth, circulating cytokines/chemokines, hepatic and kidney enzymes, blood pressure, heart rate, and tumor-infiltrating immune cells., Results: CPH:SA IL-1α-MPs demonstrated sustained release kinetics of IL-1α (100% protein released over 8-10 days) accompanied by minimal weight loss and systemic inflammation compared to rIL-1α-treated mice. Blood pressure measured by radiotelemetry in conscious mice demonstrates that rIL-1α-induced hypotension was prevented in IL-1α-MP-treated mice. Liver and kidney enzymes were within normal range for all control and cytokine-treated mice. Both rIL-1α and IL-1α-MP-treated mice showed similar delays in tumor growth and similar increases in tumor-infiltrating CD3+ T cells, macrophages, and dendritic cells., Conclusions: CPH:SA-based IL-1α-MPs generated a slow and sustained systemic release of IL-1α resulting in reduced weight loss, systemic inflammation, and hypotension accompanied by an adequate anti-tumor immune response in HNSCC-tumor bearing mice. Therefore, MPs based on CPH:SA formulations may be promising as delivery vehicles for IL-1α to achieve safe, effective, and durable antitumor responses for HNSCC patients., Competing Interests: No conflicts of interest to disclose., (© 2022 The Authors. Bioengineering & Translational Medicine published by Wiley Periodicals LLC on behalf of American Institute of Chemical Engineers.)
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- 2022
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33. Clinical Vignettes Part I.
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Levy JA, Burnett AL, Minniti CP, Ennis W, Vittal A, Heller T, Kleiner D, and Thein SL
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- Humans, Male, Adult, Quality of Life, Priapism epidemiology, Priapism etiology, Priapism therapy, Liver Diseases complications, Anemia, Sickle Cell complications, Anemia, Sickle Cell diagnosis, Anemia, Sickle Cell therapy, Leg Ulcer complications
- Abstract
Patients with sickle cell disease and/or (rarely) trait are at increased risk for developing recurrent episodes of priapism, also known as stuttering priapism, and major ischemic priapism. Treatment of acute ischemic priapism is reactive; whereas ideal management consists of preventative approaches to ultimately promote the best improvement in patient's quality of life. Leg ulcers in patients with sickle cell disease (SCD) are quite common, with ∼20 % of patients with HBSS reporting either having an active or a past ucler. They can be confused with venous ulcers, with lower extremity hyperpigmentation confounding further the diagnosis. Several factors believed to contribute to the development of leg ulcers in patients with SCD are discussed in this article. Sickle cell liver disease (SCLD) occurs because of a wide variety of insults to the liver that happen during the lifetime of these patients. SCLD includes a range of complications of the hepatobiliary system and is increasing in prevalence with the aging adult sickle population. Liver nodular regenerative hyperplasia (NRH) is more common than realized and underappreciated as a diagnosis and requires liver biopsy with reticulin staining. Undiagnosed, the insidious damage from liver NRH can lead to noncirrhotic portal hypertension or cirrhosis., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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34. Sexual health outcomes after penile reconstruction in the exstrophy-epispadias complex.
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Harris TGW, Khandge P, Wu WJ, Leto Barone AA, Manyevitch R, Sholklapper T, Bivalacqua TJ, Burnett AL, Redett RJ 3rd, and Gearhart JP
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- Male, Humans, Penis surgery, Outcome Assessment, Health Care, Epispadias surgery, Bladder Exstrophy surgery
- Abstract
Introduction: The penis in exstrophy-epispadias complex (EEC) males is diminutive and patients are often dissatisfied with appearance and length. Due to an increased risk of psychosexual dysfunction, patients desire penile reconstruction. Surgical options include penile lengthening with a full thickness skin graft (SG) or tissue expansion (TE) used for cutaneous coverage or neophalloplasty using a radial forearm free flap or pedicled antero-lateral thigh flap., Objective: The aim of this study was to assess sexual health outcomes before and after SG or TE assisted lengthening and neophalloplasty., Study Design: Patients aged 18 years or older, who underwent penile reconstruction were identified using an institutionally approved database of EEC patients. Patient perception of penile appearance, sexual function, their frequency of sexual intercourse and overall satisfaction with reconstruction were assessed using a survey consisting of validated and non-validated questions., Results: Eighty-three patients underwent penile reconstruction, 57 met the inclusion criteria and 28 responded to the survey (49.1%). Fourteen were reconstructed using a SG, 6 with TE and 8 underwent neophalloplasty. Median time from reconstruction to survey completion was 4.4 years (range 1.2-13.2) Four patients had a diagnosis of epispadias, 1 cloacal exstrophy, 23 classic bladder exstrophy (CBE). Before reconstruction patients were dissatisfied with their penile appearance with a median penile perception score of 4.5 compared to 7.5 after surgery (p = 0.0034, Fig. 1). Twenty-three patients were dissatisfied with penile length, with 18 reporting an improvement following reconstruction (p = 0.0002). There was no correlation in time after reconstruction with PPS or satisfaction with penile length (p = 0.86 and p = 0.55, respectively). Overall, the median Sexual Health Inventory for Men (SHIM) score was 19, with no difference between the surgical groups (p = 0.33). Nine patients engaged in sexual intercourse before reconstruction which increased to 17 afterwards., Conclusion: All three surgical methods improved patient perception of penile appearance and length. Patients who previously never engaged in intercourse were able to and those who had were doing so more frequently, of which a greater proportion were in a relationship. The results are encouraging though must be interpreted with caution due to the small number of responders and possible risk of bias. These findings provide vital information for future patients and routine psychological assessment will help manage patient expectations to improve satisfaction., Competing Interests: Conflict of interest None., (Copyright © 2022 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.)
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- 2022
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35. Postphalloplasty urinary function test: an observational study of novel outcome instrument to capture urinary dysfunction and quality of life after phalloplasty.
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Liu JL, Eisenbeis L, Preston S, Burnett AL, DiCarlo HN, and Coon D
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- Adult, Humans, Male, Cross-Sectional Studies, Pilot Projects, Urethra surgery, Quality of Life, Sex Reassignment Surgery
- Abstract
Due to growing social acceptance, there has been an increasing number of gender-affirmation surgeries performed in North America. Most research in this patient population focuses on surgical outcomes and advancing techniques. However, little work has been done to study functional outcomes. To better evaluate urinary dysfunction in the postphalloplasty trans men patient population, our group developed a novel patient-reported outcome instrument - the postphalloplasty urinary function test (PP UFT) and protocol to measure postvoid urethral volume (PVUR), and we present our preliminary results. We conducted a cross-sectional pilot study in a cohort of 15 adult trans men who had undergone phalloplasty with urethral lengthening surgery between 2018 and 2021. Patients had stable urinary function via the neophallus at the time of survey. Patients filled out the PP UFT and were asked to record their PVUR as per our protocol. The average PP UFT score was 8.9 out of 40 and the average quality-of-life (QOL) score was 2.6. Postvoid dribbling constituted the major complaint and on average comprised 63.2% of the reported PP UFT score. The average PVUR was 2.2 ml (range: 0.5-5.6 ml). There was a positive correlation between higher PP UFT and worse-reported quality of life (P < 0.01; R
2 = 0.4). Current questionnaires accepted in cis-male urology have limitations for accurately capturing urinary dysfunction in this specific patient group. The combination of PP UFT and PVUR measurement offers potential for quantifying urinary function and quality of life in patients who undergo phalloplasty. Future studies will validate these instruments., Competing Interests: None- Published
- 2022
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36. Testosterone and Male Sexual Function.
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Galansky LB, Levy JA, and Burnett AL
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- Male, Humans, Testosterone therapeutic use, Libido, Erectile Dysfunction, Sexual Dysfunction, Physiological etiology, Sexual Dysfunction, Physiological drug therapy
- Abstract
This article reviews the role of testosterone in normal male sexual anatomic development and function, the consequences of low testosterone on sexual function, and clinical standards for health care providers treating hypogonadal men with sexual dysfunction., Competing Interests: Disclosure The authors have nothing to disclose., (Published by Elsevier Inc.)
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- 2022
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37. Incidence and predictors of priapism events in sickle cell anemia: a diary-based analysis.
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Idris IM, Abba A, Galadanci JA, Aji SA, Jibrilla AU, Rodeghier M, Kassim A, Burnett AL, and DeBaun MR
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- Male, Humans, Infant, Female, Prospective Studies, Incidence, Pain epidemiology, Pain etiology, Priapism etiology, Priapism complications, Anemia, Sickle Cell complications
- Abstract
We conducted one of the first prospective studies to test the hypothesis that the clinical history of priapism underestimates priapism incidence compared with a priapism pain diary. Eligibility criteria were men with sickle cell anemia (SCA) between 18 and 40 years of age who have had at least 3 episodes of priapism in the past 12 months. Seventy-one men with SCA completed the diary for at least 3 months. The first 3 months of the priapism diary were included in the analysis. A total of 298 priapism episodes were recorded, and 80% (57 of 71) of the participants had at least 1 priapism event. Priapism severity was reported in the range of moderate to the worst imaginable pain in 81.5% (263 of 298), and a total 57 participants (80%) had a median pain rating of 6 (interquartile range: 5-8) on a scale from 1 to 10. The monthly incidence rate of priapism per participant based on history versus self-report pain diary was 2.0 (95% confidence interval, 1.9-2.1) and 1.4 (95% confidence interval, 1.2-1.6), respectively (P < .001). For participants that had a prior priapism episode, 80% had another episode during the 3-month interval follow-up. The median time to that second episode was 27.5 days. Major priapism occurred in 9.9% of episodes and was associated with the sum of all prospective priapism events. Men with SCA and at least 3 priapism episodes in the past 12 months are at significant risk for recurrent priapism in the following 3 months., (© 2022 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)
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- 2022
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38. Treatment patterns and burden of complications associated with sickle cell disease: A US retrospective claims analysis.
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Manwani D, Burnett AL, Paulose J, Yen GP, Burton T, Anderson A, Wang S, Lee S, and Saraf SL
- Abstract
Complications associated with sickle cell disease (SCD) that are highly impactful for patients but until recently have been less understood include priapism, nephropathy, and neurologic injury. We conducted a retrospective study using US administrative claims data from July 01, 2013 through March 31, 2020 to analyze incidence of these complications, SCD treatment patterns, and healthcare resource utilization (HCRU) and costs among 2524 pediatric and adult patients with SCD (mean [SD] age 43.4 [22.4] years). The most common treatments during follow-up were short-acting opioids (54.0% of patients), red blood cell transfusion (15.9%), and hydroxyurea (11.0%). SCD complications occurred frequently; in the overall population, the highest follow-up incidences per 1000 person-years were for acute kidney injury (53.1), chronic kidney disease (40.6), and stroke (39.0). Complications occurred across all age groups but increased in frequency with age; notably, acute kidney injury was 69.7 times more frequent among ages 65+ than ages 0-15 ( p < 0.001). Follow-up per-patient-per-month HCRU also increased with age; however, all-cause healthcare costs were similarly high for all age groups and were driven primarily by inpatient stays. Patients with SCD across the age spectrum have a high burden of complications with the use of current treatments, suggesting unmet needs for treatment management., Competing Interests: Deepa Manwani has served as a consultant for Novartis. Arthur Burnett has served as a consultant for Novartis; received grants from Boston Scientific, Futura Medical, Myriad Genetics, Comphya SA, National Institutes of Health, and Endo Pharmaceuticals; has participated in the PhenX Sickle Cell Disease Genitourinary Working Group; and has provided leadership to the Urology Care Foundation and Mentoring Male Teens in the Hood. Sara Wang is an employee of Optum, which was contracted by Novartis to conduct this study. Tanya Burton was an employee of Optum at the time this study was conducted. Amy Anderson owns stock in UnitedHealth Group and is an employee of Optum, which was contracted by Novartis to conduct the study and is a subsidiary of UnitedHealth Group. Jincy Paulose, Glorian Yen, and Soyon Lee are employees of and own stock in Novartis. Santosh Saraf has served as a consultant for Novartis, Global Blood Therapeutics, FORMA, and Agios and has served on a speakers bureau for Global Blood Therapeutics., (© 2022 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.)
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- 2022
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39. Intravascular hemolysis leads to exaggerated corpus cavernosum relaxation: Implication for priapism in sickle cell disease.
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Iacopucci APM, da Silva Pereira P, Pereira DA, Calmasini FB, Pittalà V, Reis LO, Burnett AL, Costa FF, and Silva FH
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- Acetylcholine pharmacology, Animals, Hemolysis, Humans, Male, Mice, Penis, Anemia, Sickle Cell complications, Anemia, Sickle Cell metabolism, Priapism complications
- Abstract
Patients with sickle cell disease (SCD) display priapism. Clinical studies have shown a strong positive correlation between priapism and high levels of intravascular hemolysis in men with SCD. However, there are no experimental studies that show that intravascular hemolysis promotes alterations in erectile function. Therefore, we aimed to evaluate the corpus cavernosum smooth muscle relaxant function in a murine model that displays intravascular hemolysis induced by phenylhydrazine (PHZ), as well as the role of intravascular hemolysis in increasing the stress oxidative in the penis. Corpus cavernosum strips were dissected free and placed in organ baths. Acetylcholine and electrical field stimulation (EFS)-induced corpus cavernosum relaxations in vitro were obtained. Increased corpus cavernosum relaxant responses to acetylcholine and EFS were observed in the PHZ group. Protein expression of heme oxygenase-1 increased in the corpus cavernosum of the PHZ group, but PDE5 protein expression was not modified. Preincubation with the heme oxygenase inhibitor 1 J completely reversed the increased relaxant responses to acetylcholine and EFS in PHZ mice. Protein expression of NADPH oxidase subunit gp91phox, 3-nitrotyrosine, and 4-hydroxynonenal increased in the corpus cavernosum of the PHZ group, suggesting a state of oxidative stress. Basal cGMP production was lower in the PHZ group. Our results show that intravascular hemolysis promotes increased corpus cavernosum smooth muscle relaxation associated with increased HO-1 expression, as well as increased oxidative stress associated with upregulation of gp91phox expression. Moreover, our study supports clinical studies that point to a strong positive correlation between priapism and high levels of intravascular hemolysis in men with SCD., (© 2022 Federation of American Societies for Experimental Biology.)
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- 2022
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40. Haptoglobin treatment contributes to regulating nitric oxide signal and reduces oxidative stress in the penis: A preventive treatment for priapism in sickle cell disease.
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Pereira PDS, Pereira DA, Calmasini FB, Reis LO, Brinkman N, Burnett AL, Costa FF, and Silva FH
- Abstract
Background: In sickle cell disease (SCD), reduced bioavailability of endothelial NO and cGMP results in reduced expression of phosphodiesterase type 5 (PDE5), thus impairing the penile erection control mechanism and resulting in prolonged penile erection (priapism). In SCD, reduced NO bioavailability is associated with excess plasma hemoglobin due to intravascular hemolysis and increased oxidative stress. Haptoglobin is the plasma protein responsible for reducing plasma hemoglobin levels, but in SCD, haptoglobin levels are reduced, which favors the accumulation of hemoglobin in plasma. Therefore, we aimed to evaluate the effects of haptoglobin treatment on functional and molecular alterations of erectile function, focusing on the contractile and relaxant mechanisms of corpus cavernosum (CC), as well as oxidative stress. Methods: SCD mice were treated with haptoglobin (400 mg/kg, subcutaneous) or vehicle of Monday, Wednesday and Friday for a period of 1 month. Corpus cavernosum strips were dissected free and placed in organ baths. Cumulative concentration-response curves to the acetylcholine, sodium nitroprusside, phenylephrine and KCL, as well as to electrical field stimulation (EFS), were obtained in CC. Protein expressions of eNOS, phosphorylation of eNOS at Ser-1177, nNOS, PDE5, ROCK1, ROCK2, gp91
phox , 3-nitrotyrosine, and 4-HNE were measured by western blot in CC. Results: Increased CC relaxant responses to acetylcholine, sodium nitroprusside and electrical-field stimulation were reduced by haptoglobin in SCD mice. Reduced CC contractile responses to phenylephrine and KCl were increased by haptoglobin in SCD mice. Haptoglobin prevented downregulated eNOS, p-eNOS (Ser-1177), PDE5, and ROCK2 protein expressions and reduced protein expressions of reactive oxygen species markers, NADPH oxidase subunit gp91phox, 3-nitrotyrosine and 4-HNE in penises from SCD mice. Haptoglobin treatment did not affect ROCK1 and nNOS protein expressions in penises from SCD mice. Basal cGMP production was lower in the SCD group, which was normalized by haptoglobin treatment. Conclusion: Treatment with haptoglobin improved erectile function due to up-regulation of eNOS-PDE5 expression and down-regulation of the gp91phox subunit of NADPH oxidase and oxidative/nitrosative stress in the penises of SCD mice. Treatment with haptoglobin also increased contractile activity due to up-regulation of ROCK2. Therefore, haptoglobin treatment may be an additional strategy to prevent priapism in SCD., Competing Interests: Author NB was employed by the company CSL Behring LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pereira, Pereira, Calmasini, Reis, Brinkman, Burnett, Costa and Silva.)- Published
- 2022
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41. AUA Diversity & Inclusion Task Force: Blueprint and Process for Justice, Equity, Diversity and Inclusion.
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Thavaseelan S, Burnett AL 2nd, Chang S, Davies B, Dy G, Greene K, Griebling TL, Santiago-Lastra Y, McIntire LL, McNeil B, Simons ECG, Vemulakonda V, Wood H, and Downs T
- Subjects
- Advisory Committees, Humans, Cultural Diversity, Social Justice
- Published
- 2022
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42. Demographic and Practice Trends of Rural Urologists in the U.S.: Implications for Workforce Policy.
- Author
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Garg T, Meeks WD, Coward RM, Merrill SB, Huang WC, and Burnett AL
- Abstract
Introduction: There is a shortage in the number of urologists needed to satisfy the needs of an aging U.S., Population: The urologist shortage may have a pronounced impact on aging rural communities. Our objective was to describe the demographic trends and scope of practice of rural urologists using data from the American Urological Association Census., Methods: We conducted a retrospective analysis of American Urological Association Census survey data over a 5-year period (2016-2020), including all U.S.-based practicing urologists. Metropolitan (urban) and nonmetropolitan (rural) practice classifications were based on rural-urban commuting area codes for the primary practice location zip code. We conducted descriptive statistics of demographics, practice characteristics and specific rural-focused survey items., Results: In 2020, rural urologists were older (60.9 years, 95% CI 58.5-63.3 vs 54.6 years, 95% CI 54.0-55.1) and were in practice longer (25.4 years, 95% CI 23.2-27.5 vs 21.2 years, 95% CI 20.8-21.5) than urban counterparts. Since 2016, mean age and years in practice increased for rural urologists but remained stable for urban urologists, suggesting an influx of younger urologists to urban areas. Compared with urban urologists, rural urologists had significantly less fellowship training and more frequently worked in solo practice, multispecialty groups and private hospitals., Conclusions: The urological workforce shortage will particularly impact rural communities and their access to urological care. We hope our findings will inform and empower policymakers to develop targeted interventions to expand the rural urologist workforce.
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- 2022
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43. Reply by Authors.
- Author
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Garg T, Meeks WD, Coward RM, Merrill SB, Huang WC, and Burnett AL
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- 2022
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44. Mirabegron improves erectile function in men with overactive bladder and erectile dysfunction: a 12-week pilot study.
- Author
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Karakus S, Musicki B, and Burnett AL
- Subjects
- Acetanilides, Adult, Aged, Double-Blind Method, Humans, Male, Middle Aged, Phosphodiesterase 5 Inhibitors therapeutic use, Pilot Projects, Quality of Life, Thiazoles, Treatment Outcome, Erectile Dysfunction drug therapy, Urinary Bladder, Overactive complications, Urinary Bladder, Overactive diagnosis, Urinary Bladder, Overactive drug therapy
- Abstract
Phosphodiesterase type 5 inhibitors (PDE5i) is the only approved oral treatment for erectile dysfunction (ED) in the US, and alternative management remains necessary when this treatment fails or is contraindicated. Targeting other pathways than the NO-cGMP pathway and/or combining this approach with PDE5i may introduce new treatments for men who are unresponsive to PDE5i. This study aims to evaluate whether Mirabegron improves erectile function in men with concurrent overactive bladder and mild to moderate ED. Twenty subjects, 40-70 years old, registering International Index of Erectile Function (IIEF) score 11-25 and International Prostate Symptom Score 8-20, were treated with Mirabegron therapy for 12 weeks. Study participants were re-administered IIEF and OAB-q questionnaires on weeks 2, 4, 8, and 12 and assessed for adverse events. The primary and secondary endpoints were an increase in the IIEF-5 score of 4 units and a decrease in the Overactive Bladder questionnaire (OAB-q) symptom severity score of 10 units between study time points. Thirteen men completed the 12-week study. Mirabegron treatment improved the IIEF-5 scores in five patients (38.4%) by 4 points or more, whereas IIEF-5 scores were not affected by Mirabegron treatment in eight patients (61.5%). There were no clinically relevant decreases in the IIEF-5 score. Significant improvements were observed in intercourse satisfaction at week eight compared to baseline (p = 0.01). Orgasmic function and sexual desire were not affected by Mirabegron treatment. As expected, Mirabegron treatment reduced OAB symptoms based on OAB-q short form (p = 0.006) and OAB-q total health-related quality of life (HRQL) scores compared to baseline (p = 0.03). Residual bladder volumes were not affected by treatment. No serious side effects were reported during the study period. This study suggests that Mirabegron may improve both EF and OAB-related symptoms in some individuals without causing serious adverse events., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2022
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45. Long-Term Survival Rates of Inflatable Penile Prostheses: Systematic Review and Meta-Analysis.
- Author
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Miller LE, Khera M, Bhattacharyya S, Patel M, Nitschelm K, and Burnett AL
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- Humans, Male, Middle Aged, Prosthesis Design, Prosthesis Failure, Survival Rate, Erectile Dysfunction surgery, Penile Implantation methods, Penile Prosthesis
- Abstract
The purpose of this study was to determine long-term survival of inflatable penile prosthesis (PP) and identify potential factors that may influence device survival. We performed a systematic review of Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies of men treated with inflatable PP with at least 5 years of device survival data. We performed a random effects meta-analysis to estimate device survival at 1, 3, 5, 10, 15, and 20 years of follow-up. The robustness of the meta-analysis results was evaluated in a 1-study removed sensitivity analysis and sources of heterogeneity among studies were investigated with subgroup analysis. In 12 studies (20,161 patients; median age 57 years), PP device survival was 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years. The results of the meta-analysis were not significantly influenced by single study effects in a 1-study removed sensitivity analysis. In a subgroup analysis, 5-year device survival rates were 90.6% vs 82.1% (P = .01) comparing newer vs older studies; no other patient or study design characteristic was statistically associated with device survival rates. In conclusion, the median device survival time of an inflatable PP is approximately 20 years. The factors responsible for improved device survival in newer studies remain unclear and warrant further study., Competing Interests: CONFLICT OF INTEREST LM discloses professional relationships with Boston Scientific. MK discloses no conflicts of interest. SB, MP, and KN report employment with Boston Scientific. AB discloses no conflicts of interest., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2022
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46. Resveratrol-nitric oxide donor hybrid effect on priapism in sickle cell and nitric oxide-deficient mouse.
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Pinheiro AK, Pereira DA, Dos Santos JL, Calmasini FB, Alexandre EC, Reis LO, Burnett AL, Costa FF, and Silva FH
- Subjects
- Acetylcholine pharmacology, Animals, Hemoglobins, Humans, Male, Mice, Mice, Transgenic, Nitric Oxide, Nitric Oxide Donors pharmacology, Nitroprusside pharmacology, Resveratrol pharmacology, Anemia, Sickle Cell complications, Anemia, Sickle Cell drug therapy, Priapism drug therapy, Priapism etiology
- Abstract
Background: Children and adult with sickle cell disease (SCD) display priapism associated with low nitric oxide (NO) bioavailability and oxidative stress in penis., Aim: This study aimed to evaluate the effects of hybrid compound RVT-FxMe, derived from resveratrol bearing a NO-donor subunit, on two murine model that display priapism phenotype, SCD transgenic mice and endothelial NO synthase gene-deficient (eNOS-/-) mice., Methods: Wild-type, SCD, and eNOS-/- mice were treated with RVT-FxMe (25 mg/kg/d, 2 weeks)., Outcomes: Hematological parameters, concentration-response curves to acetylcholine (ACh) and sodium nitroprusside (SNP), as well as to electrical field stimulation (EFS), were obtained in mice corpus cavernosum strips., Results: Corpus cavernosum relaxations to SNP and EFS were increased in eNOS-/- group, which were normalized by RVT-FxMe treatment. SCD mice exhibited an excessive CC relaxant response induced by ACh, EFS and SNP RVT-FxMe treatment did not change the increased relaxant responses to ACh, EFS and SNP in corpus cavernosum from SCD group., Clinical Translation: Excess of plasma hemoglobin in SCD may interfere in pharmacological activity of NO donors compounds., Strength/limitations: While mechanistic data with promising potential is showed, the current study is not without limitations. RVT-FxMe effects in the mid- and long-term warrant complementary studies., Conclusion: Treatment with RVT-FxMe reversed the enhanced NO-cGMP-mediated CC relaxations in eNOS-/- mice, but not in SCD mice; it is likely that excess of plasma hemoglobin in SCD mice act to inactivate NO before it reaches soluble guanylyl cyclase, avoiding restoration of NO bioavailability in penis., Competing Interests: The authors have declared that no competing interests exist.
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- 2022
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47. Association between Previous Pelvic Radiation and All-Cause and Cause-Specific Failure of Replacement Artificial Urinary Sphincters.
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Huang MM, Huffman P, Dani H, Knijnik PG, da Silva AF, Burnett AL, Mostwin JL, Wright EJ, and Cohen AJ
- Subjects
- Atrophy, Female, Humans, Male, Prosthesis Failure, Reoperation adverse effects, Replantation adverse effects, Retrospective Studies, Risk Assessment, Treatment Outcome, Urinary Incontinence, Stress surgery, Urinary Sphincter, Artificial adverse effects
- Abstract
Purpose: In order to accurately characterize how a history of radiation therapy affects the lifespan of replacement artificial urinary sphincters (AUSs), all possible sources of device failure must be considered. We assessed the competing risks of device failure based on radiation history in men with replacement AUSs., Materials and Methods: We identified men who had a replacement AUS in a single institutional, retrospective database. To assess survival from all-cause device failure based on radiation history and other factors, we conducted Kaplan-Meier, Cox proportional-hazards and competing risks analyses., Results: Among 247 men who had a first replacement AUS, men with a history of radiation had shorter time to all-cause device failure (median 1.4 vs 3.5 years for men with radiation vs without radiation history, p=0.02). On multivariable Cox-proportional hazards analysis, previous radiation was associated with increased risk of all-cause device failure (HR: 2.12, 95% CI: 1.30-3.43, p=0.002) . On multivariable cause-specific hazards analysis, prior radiation was associated with a higher risk of erosion/infection (HR: 7.57, 95% CI: 2.27-25.2, p <0.001), but was not associated with risk of urethral atrophy (p=0.5) or mechanical failure (p=0.15)., Conclusions: Among men with a replacement AUS, a history of pelvic radiation was associated with shorter time to device failure of any cause. Radiation was also specifically associated with a sevenfold increase in the risk of erosion or infection of replacement AUS, but not with urethral atrophy or mechanical failure. Patients with a replacement AUS should be appropriately counseled on how radiation history may impact outcomes of future revisions.
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- 2022
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48. The pulley stitch: fixation of penile prosthetic exit tubing.
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Levy JA, Bhanji Y, and Burnett AL
- Subjects
- Humans, Male, Penis surgery, Prosthesis Implantation, Erectile Dysfunction surgery, Penile Implantation methods, Penile Prosthesis
- Abstract
Proximal positioning of the penile prosthesis cylinder is performed during inflatable penile prosthesis surgery. We describe a technique to secure a prosthetic cylinder during inflatable penile prosthesis implantation. Urologists performing prosthetic surgeries employ a variety of surgical techniques to achieve successful outcomes. A surgical technique that secures the prosthetic device may ultimately mitigate cylinder migration and erosion. This is a simple, cost-effective technique that can be readily incorporated into conventional corporotomy closure procedures. It proves to be a feasible technique for both running and interrupted corporotomy closures. The "pulley stitch" offers an adjunctive technique for prosthesis cylinder positioning and may also help prevent migration of prosthetic devices, and it can be incorporated with corporotomy closure.
- Published
- 2022
49. Testosterone Deficiency in Sickle Cell Disease: Recognition and Remediation.
- Author
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Musicki B and Burnett AL
- Subjects
- Animals, Humans, Male, Mice, Penis metabolism, Testosterone, Anemia, Sickle Cell complications, Hypogonadism complications, Priapism complications, Priapism metabolism
- Abstract
Hypogonadism is common in men with sickle cell disease (SCD) with prevalence rates as high as 25%. Testicular failure (primary hypogonadism) is established as the principal cause for this hormonal abnormality, although secondary hypogonadism and compensated hypogonadism have also been observed. The underlying mechanism for primary hypogonadism was elucidated in a mouse model of SCD, and involves increased NADPH oxidase-derived oxidative stress in the testis, which reduces protein expression of a steroidogenic acute regulatory protein and cholesterol transport to the mitochondria in Leydig cells. In all men including those with SCD, hypogonadism affects physical growth and development, cognition and mental health, sexual function, as well as fertility. However, it is not understood whether declines in physical, psychological, and social domains of health in SCD patients are related to low testosterone, or are consequences of other abnormalities of SCD. Priapism is one of only a few complications of SCD that has been studied in the context of hypogonadism. In this pathologic condition of prolonged penile erection in the absence of sexual excitement or stimulation, hypogonadism exacerbates already impaired endothelial nitric oxide synthase/cGMP/phosphodiesterase-5 molecular signaling in the penis. While exogenous testosterone alleviates priapism, it disadvantageously decreases intratesticular testosterone production. In contrast to treatment with exogenous testosterone, a novel approach is to target the mechanisms of testosterone deficiency in the SCD testis to drive endogenous testosterone production, which potentially decreases further oxidative stress and damage in the testis, and preserves sperm quality. Stimulation of translocator protein within the transduceosome of the testis of SCD mice reverses both hypogonadism and priapism, without affecting intratesticular testosterone production and consequently fertility. Ongoing research is needed to define and develop therapies that restore endogenous testosterone production in a physiologic, mechanism-specific fashion without affecting fertility in SCD men., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Musicki and Burnett.)
- Published
- 2022
- Full Text
- View/download PDF
50. Penile Transplantation: Lessons Learned and Technical Considerations.
- Author
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Lake IV, Girard AO, Lopez CD, Cooney DS, Burnett AL, Brandacher G, Oh BC, and Redett RJ
- Subjects
- Humans, Male, Penis surgery, Vascularized Composite Allotransplantation
- Abstract
Purpose: Penile vascularized composite allotransplantation is a powerful tool for penile reconstruction. Traditional methods of reconstruction utilizing free tissue and prostheses have well-known complications, can require reoperation and cannot truly emulate the natural form or function of the penis. While vascularized composite allotransplantation may alleviate these difficulties, penile transplantation carries its own ethical, surgical and medical complications. To date, the procedure has only been attempted 5 times. Broader use of this procedure requires unique surgical considerations. We present the first comprehensive, detailed review of this procedure in order to present lessons learned from both our own and the global experience., Materials and Methods: A review of published reports of penile transplant methods and outcomes was conducted to compile lessons learned from these cases., Results: Five penile transplant cases have been reported in literature, 4 with published methodology and outcomes data. All 4 detailed unique surgical approaches and postoperative immunosuppressive regimens. Three of these cases resulted in successful sensory and functional outcomes., Conclusions: Though all 4 analyzed cases employed unique anastomotic and immunosuppressive approaches, 3 resulted in successful recovery of penile urinary and sexual function. Still, specific approaches used by different teams circumvented otherwise common complications, and these differences should guide future research and penile transplant cases.
- Published
- 2022
- Full Text
- View/download PDF
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