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Objective: To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). The 1-year pivotal study was extended through 2 years. The ITNS is a novel and recently FDA-approved therapy., Methods: A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory UUI to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the OAB questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of UUI episodes. The primary safety measure was device-related adverse events (AEs)., Results: Seventy-two subjects completed the 96-week evaluation. Around 78% (95% CI: 67%-87%) experienced at least 50% reduction in UUI episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their UUI episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. Around 91.3% did not require additional medications for OAB. No serious or unanticipated AEs were reported in this extension phase., Conclusion: The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating OAB patients with UUI. The findings support it as an excellent treatment option for refractory patients., Competing Interests: Declaration of Competing Interest Dr Vincent Lucente, Paid consultant to Sponsor; Study Investigator Funded by Sponsor; Stock Holder for Valencia Technologies; Dr Laura Giusto, Financial Relationship to Competitors-Proctor for Bluewind; Primary Investigator of Medtronic TITAN trial; Dr Scott MacDiarmid: Paid consultant to Sponsor; Study Investigator Funded by Sponsor; Stock Holder for Valencia Technologies., (Copyright © 2024. Published by Elsevier Inc.)

Purpose: The BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS study are presented., Materials and Methods: The Revi System was implanted in 151 female participants. The primary efficacy and safety endpoints were assessed at 6 and 12 months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety or they chose to exit the study., Results: Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6, 12, and 24 months (response rates of 78%, 82%, and 79%, respectively). Participants who completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population. In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better." There were no serious adverse events related to the device or the procedure through 24 months., Conclusions: Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile., Trial Registration: Clinicaltrials.gov Identifier: NCT03596671.

Background: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic., Objective: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available., Methods: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation., Results: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device., Conclusions: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI., (© 2024 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

There is a significant controversy on whether race should be a factor in considering active surveillance for low-risk prostate cancer. To address this question, we analyzed a multi-institution database to assess racial disparity between African-American and White-American men with low risk prostate cancer who were eligible for active surveillance but underwent radical prostatectomy. A retrospective analysis of prospectively collected clinical, pathologic and oncologic outcomes of men with low-risk prostate cancer from seven tertiary care institutions that underwent radical prostatectomy from 2003-2014 were used to assess potential racial disparity. Of the 333 (14.8%) African-American and 1923 (85.2%) White-American men meeting active surveillance criteria, African-American men were found to be slightly younger (57.5 vs 58.5 years old; p = 0.01) and have higher BMI (29.3 v 27.9; p < 0.01), pre-op PSA (5.2 v 4.7; p < 0.01), and maximum percentage cancer on biopsy (15.1% v 13.6%; p < 0.01) compared to White-American men. Univariate and multivariate analysis demonstrated similar rates of upgrading, upstaging, positive surgical margin, and biochemical recurrence between races. These results suggest that single institution studies recommending more stringent AS enrollment criteria for AA men with a low-risk prostate cancer may not capture the complete oncologic landscape due to institutional variability in cancer outcomes. Since all seven institutions demonstrated no significant racial disparity, current active surveillance eligibility should not be modified based upon race until a prospective study has been completed., Competing Interests: CONFLICTS OF INTEREST None.

Iatrogenic ureteral injuries, more than half of which occur during gynecologic surgery, may have devastating consequences for both patients and physicians. Gynecologists have employed various techniques such as cystoscopy, ureteral stents, and lighted ureteral stents to prevent ureteral injuries. The emergence and increasing prevalence of robotic surgery necessitates that we not only reevaluate the utility of these techniques, but also develop new ones specific for the robotic modality. In the robotic setting, the surgeon lacks tactile feedback and must rely primarily on visual cues. The use of intraureteral indocyanine green and subsequent visualization under near-infrared fluorescence appears to be a promising technique to primarily and secondarily prevent ureteral injuries during robotic gynecologic surgery., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Although there are reports of robot-assisted ureteral reconstructions (RURs) with excellent safety and efficacy, the procedures remain technically challenging. In the robotic setting the surgeon must rely on visual cues in the absence of tactile feedback. Indocyanine green (ICG) is a dye that can be visualized under near-infrared fluorescence (NIRF)., Objective: To describe our novel technique, which utilizes intraureteral injection of ICG and subsequent visualization under NIRF to facilitate RUR, and report our outcomes after these procedures., Design, Setting, and Participants: This is a retrospective review of 25 patients who underwent 26 RURs for various ureteral pathologies between June 2012 and October 2013., Surgical Procedure: After full disclosure, all patients consented to off-label use of ICG. A ureteral catheter and/or percutaneous nephrostomy tube were used to inject 10ml of ICG into the diseased ureter, above and below the stricture. Intraoperatively, NIRF was activated to assist in identification of the ureter and to localize the margins of ureteral strictures., Measurements: Postoperatively, RURs were assessed for clinical success (absence of symptoms attributable to ureteral pathology) and radiological success (absence of a ureteral stricture on imaging)., Results and Limitations: Our technique provided visual cues and aided in successful performance of 26 RURs in 25 patients. The procedures included ureterolysis (n=4), pyeloplasty (n=8), ureteroureterostomy (n=9), and ureteroneocystostomy (n=5). There were no perioperative complications attributable to ICG use. At a mean overall follow-up of 12 mo, all procedures were clinically and radiologically successful. This study is limited by the small sample size and short-term follow-up., Conclusions: Intraureteral injection of ICG and subsequent visualization under NIRF facilitates RUR by aiding in rapid and accurate identification of the ureter, and precise localization of the proximal and distal ureteral stricture margins. In our experience, our technique is safe, easy to perform, and reproducible., Patient Summary: In this report, we describe a new technique to facilitate robot-assisted ureteral reconstructions using intraureteral injection of ICG and subsequent visualization under near-infrared fluorescence. More specifically, our technique allows for rapid and accurate identification of the ureter, and precise localization of ureteral strictures., (Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose of Review: To describe new developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CPPS)., Recent Findings: Symptoms in men with chronic prostatitis/CPPS appear to cluster into a group with primarily pelvic or localized disease, and a group with more systemic symptoms. Several other chronic pain conditions can be associated with chronic prostatitis/CPPS, including irritable bowel syndrome, fibromyalgia, and chronic fatigue syndrome. Markers of neurologic inflammation and autoimmune disease parallel changes in symptoms after treatment. Treatment options include new alpha-blockers, psychological intervention, and prostate-directed therapy. The areas of acupuncture and pelvic floor physical therapy/myofascial release have received increased recent attention and appear to be good options in these patients. Future therapy may include antibodies to mediators of neurogenic inflammation and even treatment of bacteria in the bowel., Summary: The diagnosis of chronic prostatitis/CPPS must include conditions traditionally outside the scope of urologic practice but important for the care of men with chronic pelvic pain. The treatment is best done using multiple simultaneous therapies aimed at the different aspects of the condition.

Spermine, spermidine and a purified spleen extract (PSE) have been compared in vivo in these three tests: hemolytic plaque forming capacity in sensitized mice, delayed hypersensitivity reaction and 3H-thymidine incorporation into various tissue cells. The results obtained demonstrated that the immunosuppressive activity of PSE cannot be attributed to those polyamines. Ion exchange analysis of PSE before and after acid hydrolysis confirmed the absence of free and/or bound polyamines in the studied extract.

A low molecular weight immunosuppressive factor FA which is able to reduce the blastic transformation capacity of lymphoid cells from treated mice has been characterized. It was prepared from a bovine spleen acetone powder and found to be associated partly with high molecular weight carriers in the form of an active complex characterized previously as part of a 'lymphoid chalone' fraction. FA may be obtained by selective ultrafiltration of F followed by P-2 Biogel chromatography of the ultrafiltrate. Thymidine, deoxyinosine and deoxycytidine have been identified as the major constituents of FA by mass spectrometry, ultraviolet absorption data and thin layer chromatography. However, none of these nucleotides has the biological activity of FA.