Search

David Baunoch,1,2 Natalie Luke,2 Dakun Wang,3 Annah Vollstedt,4 Xinhua Zhao,5 Dicken SC Ko,6 Shuguang Huang,5 Patrick Cacdac,2 Larry T Sirls4 1Research/Development, Pathnostics, Irvine, CA, USA; 2Clinical Affairs, Pathnostics, Irvine, CA, USA; 3Medical Writing, Stat4ward, Pittsburgh, PA, USA; 4Women’s Urology and Pelvic Health Center, Beaumont Hospital, Royal Oak, MI, USA; 5Statistics, Stat4ward, Pittsburgh, PA, USA; 6Department of Bio Med Surgery, Warren Alpert Medical School of Brown University, Providence, RI, USACorrespondence: David Baunoch Email dbaunoch@pathnostics.comPurpose: Studies have shown that multiple genes influence antibiotic susceptibility, but the relationship between genotypic and phenotypic antibiotic susceptibility is unclear. We sought to analyze the concordance between the presence of antibiotic resistance (ABR) genes and antibiotic susceptibility results in urine samples collected from patients with symptomatic urinary tract infection (UTI).Patients and Methods: Urine samples were collected from patients presenting to 37 geographically disparate urology clinics across the United States from July 2018 to February 2019. Multiplex polymerase chain reaction was used to detect 27 ABR genes. In samples containing at least one culturable organism at a concentration of ≥ 104 cells per mL, pooled antibiotic susceptibility testing (P-AST), which involves simultaneous growing all detected bacteria together in the presence of antibiotic and then measure susceptibility, was performed against 14 antibiotics. The concordance rate between the ABR genes and the P-AST results was generated for the overall group. The concordance rates for each antibiotic between monomicrobial and polymicrobial infection were compared using chi-square test.Results: Results from ABR gene detection and P-AST of urine samples from 1155 patients were included in the concordance analysis. Overall, there was a 60% concordance between the presence or absence of ABR genes and corresponding antimicrobial susceptibility with a range of 49– 78% across antibiotic classes. Vancomycin, meropenem, and piperacillin/tazobactam showed significantly lower concordance rates in polymicrobial infections than in monomicrobial infections.Conclusion: Given the 40% discordance rate, the detection of ABR genes alone may not provide reliable data to make informed clinical decisions in UTI management. However, when used in conjunction with susceptibility testing, ABR gene data can offer valuable clinical information for antibiotic stewardship.Keywords: urinary tract infection, antibiotic resistance, antibiotic resistance genes, bacteria, culture, antibiotic susceptibility test, polymerase chain reaction

Objectives: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.)., Methods: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated., Results: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week., Conclusions: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities., (© 2022 Wiley Periodicals LLC.)

Objectives: The transobturator mid-urethral Altis ® "mini-sling" uses a static and a dynamic anchor on either end of a pulley suture for intraoperative tension adjustment. Given the potential for incorrect tensioning with sling placement, we adopted a modification for post-operative adjustment should stress urinary incontinence (SUI) persist. The objective is to describe technique, rate of postoperative adjustment driven by patient symptoms, and impact of preoperative/intraoperative variables., Methods: In this single-surgeon experience, retrospective chart review, demographic and clinical data were collected on patients who received the Altis ® sling for SUI between 2014 and 2019. We used descriptive statistics and three-group comparison tests to assess difference in variables among tightening, loosening, or no adjustment., Results: Altis ® sling placement was performed on 197 female patients with an average age of 58.7 years. Eighty-four percent (165/197) did not receive post-operative adjustment. Of the 32 patients with post-operative adjustment, 8 (4.1%) had loosening and 24 (12.2%) had tightening at an average of 10.5 days post-operatively. All tightening procedures were done in the clinic. Of the 8 patients with post-operative loosening, 6 were performed in clinic and 2 in the operating room. Preoperative and intraoperative variables were not significantly different among tightening, loosening, and no adjustment cohorts., Conclusions: This modification of the Altis ® sling provides surgeons with the ability to tighten and loosen the sling for persistent SUI. All tightening and most loosening procedures were able to be performed in the clinic. The ability to easily tighten a sling in the early post-operative period may be a critical advantage., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

Objectives: This study aimed to evaluate changes in validated symptom scores at intake and discharge in women undergoing pelvic floor physical therapy (PFPT) for pain and other pelvic floor symptoms., Methods: Consecutive women starting PFPT during 1 year were reviewed. History, demographics, and Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI) total and domain scores (Pelvic Organ Prolapse Distress Inventory-6, Urogenital Distress Inventory-6, Colorectal-Anal Distress Inventory-8), Pelvic Floor Impact Questionnaire (PFIQ-7), and pain levels on a numeric rating scale (NRS) were collected at intake and discharge. Data were analyzed with descriptive statistics and sign tests., Results: Of 474 women, mean age was 50.3 ± 16.7 years (range, 18-87 years) and the most common indication for PFPT was pelvic pain (208/474; 43.9%). In women with complete data, pretreatment to posttreatment median scores improved on the PFDI (77.3 vs 41.8; P < 0.0001), Urogenital Distress Inventory (37.5 vs 16.0; P < 0.0001), and PFIQ (58.0 vs 19.0; P < 0.0001), and the minimal clinically important difference was met for the PFDI, PFIQ, and Colorectal-Anal Distress Inventory. Women with primarily pelvic pain (n = 208) achieved significant improvements in PFDI, PFIQ, and NRS scores (P < 0.0001 for all) as well as the minimal clinically important difference for these measures. Pain patients with a history of pelvic surgery (n = 50) also had significant improvements in PFIQ and NRS but not PFDI scores., Conclusions: Most women referred to PFPT demonstrated symptom improvements as measured by validated instruments., Competing Interests: K.A.K., J.L.H., E.H., Y.L.D., L.N., J.G., L.O., and J.A.B. have declared they have no conflicts of interest. K.M.P. is a consultant for Urogen and Teva and a founder/equity owner of StimGuard, LLC. L.T.S. is an investigator for StimGuard and Cook and a consultant for J&J., (Copyright © 2019 American Urogynecologic Society. All rights reserved.)

Purpose: To determine the rate of antibiotic change in an outpatient setting following empiric treatment of culture proven UTI and to identify risk factors associated with change., Methods: Patients with suspected UTI and urine culture were reviewed (January 2016-June 2016). Those with a positive culture were categorized by whether or not they were treated empirically. Empiric treatment was evaluated for associations with clinical-demographic data, symptoms and urinalysis (UA). Antibiotic change was evaluated with clinical-demographic data, urine culture, and resistance patterns., Results: 916 urine cultures (636 patients) were included. 391 (43%) cultures were positive, and 164 (42%) were treated empirically. Clinical-demographic data did not differ between groups. Those treated empirically had more documented UTI symptoms (93 vs 58%, P < 0.001), and UA abnormalities including positive nitrites (51 vs 29%, P < 0.001), 3 + leukocyte esterase (27 vs 19%, P = 0.002) and 3 + blood (13 vs 4%, P = 0.005). Of those treated empirically, 42/164 (26%) required an antibiotic change, and this was associated with immunosuppression (12 vs 2%, P = 0.027) resistance to > 3 antibiotics (33 vs 20%, P = 0.039) and also resistance to fluoroquinolone (50 vs 30%, P = 0.016), monobactam (19 vs 7% P = 0.042) and TMP-SMX (52 vs 19%, P < 0.001)., Conclusions: Almost one-quarter of patients treated empirically required antibiotic change. This was driven largely by bacterial resistance. New technologies allowing rapid bacterial identification and sensitivity may improve patient care.

Objectives: Chronic pelvic pain in women often requires multimodal treatment regimens. We describe our method of transvaginal trigger point injections (TPIs) and report outcomes using change in pain scores., Methods: This was a retrospective review of women treated with in-office pelvic floor muscle injections from January 2012 to August 2015. Lidocaine 1% and 2%, bupivacaine 0.5%, or ropivacaine 0.5% with or without the addition of triamcinolone 40 mg was used for the injections. Pain was reported on a 0- to 10-point numerical rating scale before and after injection. Differences in pretreatment and posttreatment pain scores were analyzed after the first injection and after subsequent injections. Repeated-measures analysis was used to determine if any variable affected treatment response., Results: One hundred one women with a mean age of 44 years had a total of 257 separate visits for pelvic floor muscle injections. Triamcinolone was used at 90.2% (230/255) of the TPI visits. After the initial TPI visit, there was significant decrease in total levator numerical rating scale score (maximum score, 20; mean, -6.21 ± 4.7; P < 0.0001), and 77% (70/91) of patients had improved. These significant improvements were noted at all visits 1 through 4 and whether bilateral or unilateral injections were done. Only the total amount of local anesthestic used had a significant effect on the change in total levator pain scores (P = 0.002). Minor adverse effects including leg numbness, dizziness, nausea, bleeding, and headache occurred at 10% of visits., Conclusions: Pelvic floor muscle injections decrease pain levels in women with pelvic floor dysfunction.

Objective: To evaluate the effect of different surgical procedures on Pelvic Floor Distress Inventory (PFDI) scores in women with pelvic organ prolapse., Materials and Methods: Women with prolapse were enrolled from 2008 to 2014. Baseline data and outcomes at 1 year were collected including subscales of the PFDI. Patients who had surgery (SGY) within the first year were compared to those who did not (N-SGY). Subanalyses of SGY included vaginal vs abdominal, with or without concurrent hysterectomy (HYST, N-HYST), placement of mesh (MESH, N-MESH), and concurrent posterior repair/perineorrhaphy (POST, N-POST)., Results: A total of 233/239 patients underwent surgery in the first year. For SGY vs N-SGY, SGY had significant improvements in PFDI and all subscale scores at 1 year while N-SGY did not. When comparing vaginal to abdominal approach, MESH to N-MESH and HYST to N-HYST, there were no differences between any scores at baseline or 1 year between the groups. However, all within group symptom scores improved from baseline to 1 year (P <.0001 for all). In comparing POST to N-POST, there were no differences between groups at 1 year in PFDI and Urogenital Distress Inventory and Pelvic Organ Prolapse Distress Inventory subscale scores. Colorectal-Anal Distress Inventory scores were significantly higher at baseline for POST (P <.0001) but not at 1 year (P = 0.37). All within group scores statistically significant improved at 1 year., Conclusion: Women who underwent surgical repair for prolapse had significantly improved overall PFDI and subscale scores regardless of surgical approach and concurrent procedures., (Copyright © 2018. Published by Elsevier Inc.)

Introduction: Robotic-assisted laparoscopic prostatectomy (RALP) has largely replaced open radical prostatectomy in many centers. Radical perineal prostatectomy (RPP) is another less invasive approach that has not been widely adopted. RPP offers excellent exposure of the urinary sphincter and bladder neck that may provide good urinary function outcomes. We evaluate urinary function after RALP and RPP., Methods: Retrospective review of a prospective radical prostatectomy database was performed. Urinary modules from the Expanded Prostate Cancer Index Composite-Urinary Function (EPIC-UF) questionnaire were used to determine urinary symptoms at baseline and at 6, 12, 18, and 24 months after surgery., Results: 753 men underwent RALP (n = 623) or RPP (n = 130). Of these, 558 had complete data and were included in our study (RALP: n = 458, RPP: n = 100). A higher number of patients undergoing RALP than RPP had pelvic lymph node dissection (20.2% vs. 0%, p < 0.0001) and cavernosal neurovascular bundle sparing (79.2% vs. 68.4%, p < 0.0001). 558 patients had complete EPIC-UF data. Overall urinary recovery was greater for RALP than RPP at 6 months (p = 0.028). Urinary incontinence and function were also more improved after RALP compared to RPP at 6 months (p = 0.021, p = 0.006). However, no differences in overall, urinary incontinence, or urinary function scores were seen at 12, 18, or 24 months. There was no difference between groups in urinary bother or irritative/obstructive symptoms at any time point., Conclusions: RALP had more rapid recovery of urinary function at 6 months vs. RPP; at 12-24 months, however, RALP and RPP had similar urinary function recovery in all urinary subdomains.

Objectives: Injectable urethral bulking agents are commonly used to manage stress urinary incontinence. Urologic or other symptoms may prompt pelvic imaging at a later date, when bulking agents may be visualized and incorrectly interpreted. Our goal was to evaluate the incidence of misdiagnosis and which pathologies were the most common misinterpretations and their frequency., Methods: All records were reviewed for patients who underwent periurethral injection for stress urinary incontinence for pelvic imaging after treatment from 2005 to 2015. Radiological reports were reviewed for any description potentially related to injection therapy, and descriptive statistics performed., Results: A total of 528 patients underwent injection of a urethral bulking agent. Of these, 79 patients (15%) had a total of 111 additional abdominal or pelvic imaging studies performed with abnormal periurethral findings mentioned. Thirty-nine (35%) of 111 studies were correctly interpreted as urethral bulking agents, and in 72 (65%) of 111 studies, the urethral bulking agents were not correctly identified. The most common misdiagnoses were bladder calcification (26; 23%), urethral diverticulum with stone (12; 11%), periurethral calcification (9; 8%), unknown pelvic density (8; 7%), and mass suspicious for malignancy (6; 5%)., Conclusions: Urethral bulking agents commonly were not mentioned on subsequent imaging but, when commented on, were misinterpreted 65% of the time including worrisome pathologies (diverticulum with stone, unknown mass, and malignancy), requiring subsequent evaluation and potentially procedural/surgical management. It is critical for the ordering clinician to inform the radiologist of this history and for radiologists to consider bulking agents in the differential diagnosis of radiographic findings in this location.

Objectives: To evaluate additional treatments, symptoms, satisfaction and quality of life 1 year after vaginal and abdominal pelvic organ prolapse (POP) repair., Methods: Adult women enrolled in a prospective POP database were reviewed. Baseline and outcomes data 1 year after surgery were collected including the Pelvic Floor Distress Inventory (PFDI) and mailed surveys. Data were analyzed with descriptive statistics, Fisher's exact tests and t tests., Results: Of 222 women, 147 (66%) had vaginal and 75 (34%) had abdominal repair. Vaginal group patients were older (64.1 vs. 59.7 years; p = 0.003), but other demographic characteristics did not differ. Vaginal group patients had lower baseline anterior and apical prolapse grades (anterior 2.7 vs. 3.1, p = 0.003; apical 2.1 vs. 3.1, p < 0.001). Baseline PFDI scores were similar. Scores improved significantly for both groups after 1 year, but 1-year PFDI scores were significantly higher in the vaginal group (45.6 vs. 32.6, p = 0.032). Scores were not different when adjusted for age and prolapse grade (p = 0.24). At 1 year, most patients in the vaginal and abdominal groups reported moderately/markedly improved overall symptoms (72/108 vs. 50/60, p = 0.030) and quality of life (89/101 vs. 54/59, p = 0.601). Most were satisfied with surgery (68/101 vs. 48/59, p = 0.067). Retreatment rates (pelvic floor physical therapy, medications, coping strategies, surgical procedures) were similar (34/109 vs. 15/62, p = 0.381). Vaginal mesh use did not affect additional treatments, patient satisfaction or symptoms., Conclusions: Although symptoms improve and most women are satisfied with surgery, about one in four women have additional therapy in the first year after POP repair.

Introduction: Women with pelvic floor dysfunction can have tender areas on vaginal examination, which can be treated with trigger-point injections. There are no publications to evaluate the accuracy of pelvic floor muscle injections., Methods: Trigger-point injections were performed on 2 fresh cadaveric pelvises using a curved nasal cannula guide and 7-in spinal needle. This was performed using our standard template of 2 sets of injections at the 1-, 3-, and 5-o'clock positions distally and proximally. The first pelvis was dissected to examine dye penetration. Based on these results, we modified our technique and repeated the injections on the second cadaver. We dissected the second pelvis and compared our findings., Results: The 1-o'clock proximal and distal injections stained the obturator internus and externus near the insertion at the ischiopubic ramus. The 3-o'clock injections stained the midbody of the pubococcygeus and puborectalis. The distal 5-o'clock position was too deep and stained the fat of the ischiorectal space. The proximal 5-o'clock injection stained the area of the pudendal nerve. Our goal at the distal 5-o'clock position was to infuse the iliococcygeus muscle, so we shortened the needle depth from 2 to 1 cm beyond the cannula tip. In our second dissection, the distal 5-o'clock injection again stained only the fat of the ischiorectal space., Conclusions: This is the first study to characterize the distribution of pelvic floor muscle injections in a cadaver model and confirms the ability to deliver medications effectively to the pelvic floor muscles.

Introduction and Hypothesis: To examine changes in sexual function after abdominal and transvaginal pelvic organ prolapse repair., Methods: Women enrolled in our prospective, longitudinal prolapse database with abdominal sacrocolpopexy (ASC) or transvaginal (TVR) pelvic organ prolapse (POP) repair with or without mesh, between 19 December 2008 through 4 June 2014. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and the Pelvic Floor Distress Inventory (PFDI -20) were mailed preoperatively, and at 6 and 12 months postoperatively. Patients completed Global Response Assessments to rate their overall satisfaction., Results: Two hundred and four of the 300 women met the inclusion criteria: 74 out of 204 (36 %) had ASC and 130 out of 204 (64 %) had TVR. Seventy-two out of seventy-four ASCs were performed robotically and 2 were open. Baseline demographics were similar except that the ASC patients were significantly younger (60 vs 63, P = 0.019) and had a higher rate of apical repair (77 % vs 55 %). Thirty-six out of seventy-four ASC (48.7 %) and 63 out of 128 TVR patients (49.2 %) were sexually active at baseline (P = 0.94). Sixteen out of thirty-eight ASC (42.1 %) and 18 out 63 TVR patients (28.6 %; P = 0.16) reported dyspareunia at baseline. Seventy-two out of seventy-four ASC (97 %) and 86 out of 130 TVR patients (66 %) had mesh-augmented repairs. There was no difference in sexual activity or dyspareunia between the groups at the 6- or 12-month follow-up. PISQ and PFDI scores improved significantly in both the ASC and TVR groups over time compared with the baseline (p < 0.0001). Most women in the ASC (77.5 %) and TVR (64.8 %) groups were satisfied with the results of prolapse surgery at 12 months., Conclusions: Sexual function and pelvic floor symptoms improved in a similar manner in patients after abdominal and transvaginal POP surgery.

Objective: To evaluate the hospital-realized cost difference between transvaginal mesh prolapse repair and robot-assisted sacrocolpopexy., Methods: Consecutive transvaginal mesh prolapse surgery and robot-assisted sacrocolpopexy cases from January 2012 to December 2013 were evaluated. Patient clinical and operative data were recorded. The total institutional costs (direct and indirect) for each procedure were obtained and subcategorized by area. Independent sample t tests and chi-squared analysis were performed., Results: One hundred twenty women underwent transvaginal mesh repair whereas 106 underwent robotic sacrocolpopexy. Body mass index was similar between groups (28.1 vs 27.5) as was midurethral sling placement (50% vs 59%). Robotic patients were younger (61 years vs 67 years., P < .001) and more likely to undergo concomitant hysterectomy (58.5% vs 26.7%). There were similar rates for additional compartment repairs. Amortized costs for robotic purchase and maintenance were included with all depreciated equipment and realized by all patients undergoing surgery. Overall mean robotic operative time was longer with and without hysterectomy (279 minutes vs 174 minutes, P < .001 and 201 minutes vs 91 minutes, P < .001). Mean total costs were higher with robotic technique ($9675 vs $6718, P < .001), primarily driven by anesthesia ($1141 vs $675, P < .001), and operative ($6883 vs $4487, P < .001) costs. No differences for total costs were seen in laboratory fees, recovery room, or inpatient nursing., Conclusion: Transvaginal prolapse repair is less costly than robotic sacrocolpopexy. Length of surgery and additional robotic supplies drive the majority of increased operative costs. Costs attributed to robot purchase and maintenance do not uniquely factor into the procedure costs., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: To determine the best predictor of the mid urethral sling outcome we calculated the AUC of ROC curves of preoperative parameters, including Valsalva leak point pressure, maximum urethral closure pressure, urinary NTx (N-telopeptide of crosslinked type I collagen) and plasma vitamin D values (D2, D3 and D2 plus D3)., Materials and Methods: This was an ancillary study of TOMUS (Trial of Mid-urethral Slings) and the ValUE (Value of Urodynamics Evaluation) trial in which subjects underwent mid urethral sling surgery for stress urinary incontinence. Valsalva leak point pressure and maximum urethral closure pressure were measured in 427 subjects, whereas NTx, vitamin D2, vitamin D3 and vitamin D2 plus D3 levels were obtained from 150, 116, 115 and 116 subjects respectively. Outcome success was defined using identical outcome (subjective and objective) variables for all subjects. ROC curves with corresponding AUC values were compared., Results: TOMUS and ValUE subjects were significantly different in age, body mass index, UDI (Urogenital Distress Inventory) scores. TOMUS subjects had a lower surgical success rate compared to ValUE subjects (66.3% vs 76.0%, p = 0.03). The AUC values of Valsalva leak point pressure, maximum urethral closure pressure, NTx, and vitamins D2, D3 and D2 plus D3 were 0.542, 0.561, 0.702, 0.627, 0.645 and 0.640, respectively. The AUC of NTx was significantly higher than the AUCs of Valsalva leak point pressure and maximum urethral closure pressure (p = 0.02 and 0.03, respectively)., Conclusions: Urinary NTx was the best predictor of the mid urethral sling outcome. This test is not only noninvasive, it is also modifiable. Finding ideal modifiable risk factors prior to mid urethral sling surgery should be subject to future investigations., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to assess the efficacy, efficiency, and costs of 2 methods of trial of void (TOV) after midurethral sling (MUS) placement., Methods: A retrospective chart review was performed on women who underwent outpatient MUS between January 2013 and April 2014 by 3 urologists. Patients were excluded if they had a concomitant prolapse repair, hysterectomy, bladder/urethral injury, or any procedure that may prolong recovery room (RR) stay. Trial of void was performed by either (1) bladder instillation, catheter removal in the operating room (OR) fill with attempted void in RR, or (2) bladder instillation and catheter removal with immediate attempted void in the RR fill. Intraoperative, postoperative, and cost data were analyzed., Results: Ninety-one of 183 women (mean age, 55.9 ± 12 years; mean body mass index, 28.8 ± 5.8 kg/m) met inclusion criteria. Eighty-three had a transobturator sling. Forty-nine (54%) had an OR fill and 42 (46%) had an RR fill; age and body mass index were similar between groups. The OR fill group had shorter median operative time (15 vs 22 minutes; P = 0.003) and median RR time (138 vs 161, P = 0.033). The OR fill and RR fill groups did not differ in TOV failure rate (3/49 vs 6/42; P = 0.29), overall mean LOS (4.96 vs 5.51 hours; P = 0.055), and median RR costs ($627 vs $678; P = 0.065). No patient had urinary retention after successful TOV., Conclusions: After MUS placement, both OR fill and RR fill TOV methods are effective and efficient with similar TOV failure rates.

Pelvic organ prolapse repair with mesh remains the gold standard for advanced prolapse. There are several surgical approaches available to the pelvic reconstructive surgeon. Prolapse repair can be performed vaginally or abdominally using native tissue or may be augmented with a biologic or mesh patch. In this article, we will review the different approaches to prolapse repair, the role of mesh, and the risks and benefits of each option. Patient selection, surgical technique, and the rationale for using mesh will be explored. Complications from prolapse repair with mesh including dyspareunia, pelvic pain, mesh exposure, and reoperation will be discussed.

Aims: Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis., Methods: This is a secondary analysis from the Value of Urodynamic Evaluation (ValUE) trial, a multicenter non-inferiority randomized trial to determine whether a basic office evaluation (OE) is non-inferior in terms of SUI surgery outcomes to office evaluation with addition of urodynamic studies (UDS). All participants underwent an OE; those patients who randomized to supplementary UDS underwent non-instrumented uroflowmetry, filling cystometry, and a pressure flow study. Costs associated with UDS were calculated using 2014 U.S. Medicare allowable fees. Models using various patient populations and payor mixes were created to obtain a range of potential costs of performing UDS in patients undergoing SUI surgery annually in the United States., Results: Six hundred thirty women were randomized to OE or OE plus UDS. There was no difference in surgical outcomes between the two groups. The per patient cost of UDS varied from site to site, and included complex cystometrogram $314-$343 (CPT codes 51728-51729) plus complex uroflowmetry $16 (CPT code 51741). Extrapolating these costs for US women similar to our study population, 13-33 million US dollars could be saved annually by not performing preoperative urodynamics., Conclusion: For women with uncomplicated SUI and a confirmatory preoperative basic office evaluation, tens of millions of dollars US could be saved annually by not performing urodynamic testing. In the management of such women, eliminating this preoperative test has a major economic benefit., (© 2014 Wiley Periodicals, Inc.)

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a complex syndrome that has long been treated with bladder directed therapies, which often fail to address the multiple underlying etiologies that can contribute to this disease process. This disease often involves symptoms that extend beyond the bladder and involve the pelvic floor making it crucial for clinicians to approach the patient using a multidisciplinary team. This article will discuss the underlying etiologies for IC/BPS and describe the multidisciplinary approach which we have found to be extremely successful in managing this patient population.

Objective: To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline., Methods: This is a secondary analysis of data from three multicenter urinary incontinence (UI) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The primary outcome was improvement of 70% or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale. Surgical groups were compared within respective trials. Generalized linear models were fit using 1-year and up to 5-year data., Results: Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery (P<.001). Most women (50-71%) reported improvement in OAB symptoms. Improvements were similar between midurethral sling groups at 1 year (65.5% compared with 70.7%, P=.32; odds ratio [OR] 0.83, 95% confidence interval [CI] 0.57-1.20 for retropubic compared with transobturator sling) and throughout the 5-year follow-up period. More women reported OAB symptom improvement after Burch compared with pubovaginal sling (67.9% compared with 56.6%, P=.01; OR 1.59, 95% CI 1.10-2.31 for Burch compared with sling); this group difference at 1 year persisted throughout the 5-year follow-up. At 1-year, 50.0-64.3% of patients reported 70% greater improvement in UI. This proportion declined to 36.5-54.1% at 5 years (P<.001). Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery., Conclusion: Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time. Obesity blunted symptom improvement., Level of Evidence: II.

Objectives: To explore the need for secondary surgical procedures after transvaginal prolapse repair with mesh., Methods: Women that had prolapse repair (Prolift(®) or Elevate(®)) were reviewed for reoperation and clinical/demographic data such as prior prolapse repair, prolapse grade, operative details, length of stay (LOS) and time to reoperation. Pearson's Chi-square, Fisher's exact tests and Wilcoxon rank tests were used., Results: 77/335 women (23%) had 100 additional procedures. Median (range) time to reoperation was 51 (5-1168) days: four (1%) had primary prolapse surgery at a different site, three (1%) repeat prolapse repair from the same site, 23 (7%) surgery for complications and 50 (15%) had stress urinary incontinence (SUI)/sling-related procedures. When no reoperation versus reoperation groups were compared, mean LOS (1.8 vs. 2.0 days; p = 0.044) and follow-up (228 vs. 354 days; p = 0.002) were longer in the reoperations group; postoperative hemoglobin was lower (10.8 vs. 10.4; p = 0.031). Patients with a prolapse reoperation were 10 years younger (67 vs. 57 years; p = 0.027) than patients that either had a reoperation for other reasons or had no reoperations. Patients with concomitant sling and persistent SUI requiring repeat SUI surgery were older (mean 72 vs. 66 years; p = 0.038), had prior prolapse repair (53 vs. 27%; p = 0.017) and had anterior compartment mesh (84 vs. 56%; p = 0.037); median operative times (78 vs. 104 min; p = 0.008) and mean LOS were shorter (median 1.6 vs. 1.9 days; p = 0.045). For patients without concomitant sling, no demographic or perioperative differences were found between those that did (n = 10) and did not (n = 86) develop de novo SUI that required reoperation., Conclusions: Most reoperations were for sling management and SUI; few were for mesh complications or prolapse recurrence.

Introduction: Minimum important difference (MID) estimates the minimum degree of change in an instrument's score that correlates with a patient's subjective sense of improvement. We aimed to determine the MID for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) using both anchor based and distribution based methods derived using data from the Trial of Midurethral Slings (TOMUS)., Materials and Methods: Instruments for the anchor-based analyses included the urogenital distress inventory (UDI), incontinence impact questionnaire (IIQ), patient global impression of improvement (PGI-I), incontinence episodes (IE) on 7-day bladder diary, and satisfaction with surgical results. After confirming moderate correlation (r ≥ 0.3) of ICIQ-UI SF and each anchor, MIDs were determined by calculating the difference between the mean instrument scores for individuals with the smallest amount of improvement and with no change. The distribution-based method of MID assessment was applied using effect sizes of 0.2 and 0.5 SD (small to medium effects). Triangulation was used to examine these multiple MID values in order to converge on a small range of values., Results: Anchor-based MIDs range from -4.5 to -5.7 at 12 months and from -3.1 to 4.3 at 24 months. Distribution-based MID values were lower. Triangulation analysis supports a MID of -5 at 12 months and -4 at 24 months., Conclusion: The recommended MIDs for ICIQ-UI SF are -5 at 12 months and -4 at 24 months. In surgical patients, ICIQ-UI SF score changes that meet these thresholds can be considered clinically meaningful., (© 2013 Wiley Periodicals, Inc.)

Neuromodulation is an important treatment modality for a variety of pelvic floor disorders. Percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) are currently the two approved methods for delivering this therapy. Percutaneous tibial nerve stimulation is a minimally invasive office-based procedure that has shown efficacy in the treatment of overactive bladder, fecal incontinence, and pelvic pain. It has the advantage of minimal side effects but is limited by the need for patients to make weekly office visits to receive the series of treatments. Sacral neuromodulation uses an implanted device that stimulates the S3 nerve root and can improve symptoms of overactive bladder, non-obstructive urinary retention, fecal incontinence, and pelvic pain. This paper will review the most recent literature regarding this topic and discuss their advantages and limitations and recent innovations in their use.

Purpose: Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings., Materials and Methods: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events., Results: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4)., Conclusions: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate., (Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: This study examined the association between the need for a repeat voiding trial after midurethral sling (MUS) surgery and 1-year success rates., Methods: We conducted this secondary analysis of the participants in the Urinary Incontinence Treatment Network trial of midurethral sling (TOMUS) study which compared retropubic versus transobturator MUS. A standard voiding trial was attempted on all subjects. The "repeat voiding trial" group included subjects discharged with catheterization. All others were considered "self voiding." Success rates between the groups at 1-year were compared, followed by multivariate analyses controlling for previously reported clinical predictors of success., Results: Most women (76%) were self-voiding, while 24% required a repeat voiding trial. The objective success rate at 1-year was 85.8% in the repeat voiding trial group and 75.3% in the self-voiding group (P = 0.01). Subjective success rate at 1-year was 61.0% in the repeat voiding trial group and 55.1% in the self-voiding group (P = 0.23). Women in the repeat voiding trial group continued to demonstrate greater objective success than the self-voiding group in multivariate analysis that controlled for previous incontinence surgery, pad weight, urethral mobility, urge score, and type of MUS (P = 0.04, OR 1.82, 95% CI 1.03-3.22)., Conclusions: Women who require a repeat voiding trial following MUS surgery have greater objective success at 1-year postoperatively when compared to those who are self-voiding at the time of discharge. These results may help reassure women who require catheterization after MUS surgery that their outcome is not compromised by this immediate transient post-operative result., (© 2013 Wiley Periodicals, Inc.)

Purpose: We assess the 12-month safety and potential efficacy of autologous muscle derived cells for urinary sphincter repair (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) in women with stress urinary incontinence., Materials and Methods: Pooled data from 2 phase I/II studies with identical patient selection criteria and outcome measures were analyzed. Enrolled patients had stress urinary incontinence refractory to prior treatment and no symptom improvement during the last 6 months. Patients received intrasphincter injection of 10 (16), 50 (16), 100 (24) or 200×10(6) (24) autologous muscle derived cells for urinary sphincter repair, derived from biopsies of each patient's quadriceps femoris. The primary outcome measure was safety, determined by incidence and severity of adverse events. Potential efficacy was measured by changes in 3-day voiding diaries, 24-hour pad tests, and UDI-6 and IIQ-7 scores., Results: A total of 80 patients underwent injection of autologous muscle derived cells for urinary sphincter repair, and 72 completed diaries and pad tests at 12-month followup. No adverse events attributed to autologous muscle derived cells for urinary sphincter repair were reported. Higher dose groups tended to have greater percentages of patients with at least a 50% reduction in stress leaks and pad weight at 12-month followup. All dose groups had statistically significant improvement in UDI-6 and IIQ-7 scores at 12-month followup compared to baseline., Conclusions: Autologous muscle derived cells for urinary sphincter repair at doses of 10, 50, 100 and 200×10(6) cells appears safe. Efficacy data suggest a potential dose response with a greater percentage of patients responsive to higher doses., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to report the frequency of abnormal cystoscopy at incontinence surgery and to identify risk factors and sequelae of injury., Study Design: Findings of cystoscopy were collected prospectively in 3 multicenter surgical trials. Clinical, demographic, and procedure characteristics and surgeon experience were analyzed for association with iatrogenic injury and noninjury abnormalities. Impact of abnormalities on continence outcomes and adverse events during 12 months after the procedure were assessed., Results: Abnormal findings in the bladder or urethra were identified in 95 of 1830 women (5.2%). Most injuries (75.8%) were iatrogenic. Lower urinary tract (LUT) injury was most common at retropubic urethropexy and retropubic midurethral sling (MUS) procedures (6.4% each), followed by autologous pubovaginal sling procedures (1.7%) and transobturator MUS (0.4%). Increasing age (56.9 vs 51.9 years; P = .04), vaginal deliveries (3.2 vs 2.6; P = .04), and blood loss (393 vs 218 mL; P = .01) were associated with LUT injury during retropubic urethropexy; however, only age (62.9 vs 51.4 years; P = .02) and smoking history (P = .04) were associated for pubovaginal sling procedures. No factors correlated with increased risk of injury at retropubic and transobturator MUS. Notably, previous incontinence surgery, concomitant procedures, anesthesia type, and trainee participation did not increase LUT injury frequency. Although discharge with an indwelling catheter was more common after trocar perforation compared with the noninjury group (55.6% vs 18.5%; P < .001), they did not differ in overall success, voiding dysfunction, recurrent urinary tract infections, or urge urinary incontinence., Conclusion: Universal cystoscopy at incontinence surgery detects abnormalities in 1 in 20 women. Urinary trocar perforations that are addressed intraoperatively have no long-term adverse sequelae., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Overactive bladder (OAB) is a symptom complex of urinary frequency, nocturia and urgency with or without urgency incontinence that adversely impacts patient's quality of life. Conservative management begins in the outpatient clinic, often with significant improvement and patient satisfaction. In this review we will discuss the evaluation of OAB and review treatment options focusing on behavioral modification, medical therapy, and neuromodulation. These treatment options are offered in a stepwise fashion, remembering that more than one may be needed and can be used concomitantly.

Objectives: To evaluate clinical, demographic, and surgical factors that may be associated with mesh exposure after vaginal repair of pelvic organ prolapse (POP)., Methods: Records of women who underwent POP repair with Elevate or Prolift were retrospectively reviewed. Body mass index (BMI), prolapse grade, smoking history, diabetes, steroid and estrogen use, parity, compartment repaired, concurrent hysterectomy, operative time, postoperative pain, change in hemoglobin (ΔHgb) and other characteristics were evaluated for associations with mesh exposure.Categorical variables were examined using Pearson χ test where appropriate, or the Fisher exact test was used. The continuous variables were examined using Wilcoxon rank tests. A multivariable logistic regression analysis was completed to examine predictors of mesh exposure. All analyses used SAS for Windows version 9.2 (Cary, NC)., Results: Three hundred thirty-five women underwent repair from 2006 to 2011. Vaginal mesh exposure was identified in 27 (8.1%) of the 335 women. Patients with exposure had longer median follow-up than the group with no exposure (357 vs 145 days; P = 0.0003). The median time to exposure was 96 days (15-1129 days). Mesh exposure was associated with lower BMI (25.2 ± 2.5 vs 27.4 ± 5.1; P = 0.020) and greater ΔHgb (-3.7 ± 1.7 mg/dL vs -2.5 ±1.3; P = 0.0011). Change in hemoglobin decreased over time (P = 0.0005). Exposure rates also decreased over time (17% in 2005 to 12% in 2006, then 5%-8% in 2006-2011) but were not statistically significant (P = 0.49)., Conclusions: In this study, vaginal mesh exposure was only associated with ΔHgb and lower BMI.

Introduction and Hypothesis: We compared the operative and immediate postoperative experience of the trocar-based Prolift and non-trocar-based Elevate techniques used to repair vaginal prolapse., Methods: A retrospective review of Prolift and Elevate repairs was performed. Baseline characteristics and operative and postoperative variables evaluated included compartment(s) repaired, adjacent organ injury, operative time (OT), change in hemoglobin (ΔH), pain score, narcotic use, length of stay (LOS), and short-term complications. Categorical variables were assessed as counts and percent frequency. Data were compared using chi-squared analysis and paired t test., Results: Prolift (n = 143) and Elevate (n = 77) patients were similar in age (p = 0.19). Concurrent hysterectomy was done in 22 (15.4 %) and 24 (31.2 %), respectively, and concurrent midurethral sling placed in 100 (70 %) and 50 (65 %), respectively. LOS (median, 25th,75th) after anterior/apical compartment repairs was shorter with Elevate, whether with (1.0; 1.0,1.5 vs. 2.0 days;1.0, 2.0; p = 0.003) or without (2.0; 1.0, 2.0 vs. 2.0 days; 2.0, 3.0; p = 0.024) hysterectomy, but no differences in OT, ΔH, pain score, or narcotic use occurred. Posterior compartment mean pain scores were lower with Prolift (3.6 ± 2.2 vs. 1.7 ± 1.5, p = 0.035), and three-compartment-repair pain scores were lower with Elevate (0.6 ± 1.3 vs 2.5 ± 1.9; p = 0.013). Three bladder injuries occurred with Prolift but none with Elevate., Conclusions: Operative and postoperative experiences were similar between groups; however, Elevate anterior/apical repairs had shorter LOS, which might reflect more aggressive discharge planning. There were no bowel or major vascular injuries, and the Prolift trocar bladder injuries did not alter the surgical procedure.

Purpose: We evaluated the influence of preoperative urodynamic studies on diagnoses, global treatment plans and outcomes in women treated with surgery for uncomplicated stress predominant urinary incontinence., Materials and Methods: We performed a secondary analysis from a multicenter, randomized trial of the value of preoperative urodynamic studies. Physicians provided diagnoses before and after urodynamic studies and global treatment plans, defined as proceeding with surgery, surgery type, surgical modification and nonoperative therapy. Treatment plan changes and surgical outcomes between office evaluation and office evaluation plus urodynamic studies were compared by the McNemar test., Results: Of 315 subjects randomized to urodynamic studies after office evaluation 294 had evaluable data. Urodynamic studies changed the office evaluation diagnoses in 167 women (56.8%), decreasing the diagnoses of overactive bladder-wet (41.6% to 25.2%, p <0.001), overactive bladder-dry (31.4% to 20.8%, p = 0.002) and intrinsic sphincter deficiency (19.4% to 12.6%, p = 0.003) but increasing the diagnosis of voiding dysfunction (2.2% to 11.9%, p <0.001). After urodynamic studies physicians canceled surgery in 4 of 294 women (1.4%), changed the incontinence procedure in 13 (4.4%) and planned to modify mid urethral sling tension (more or less obstructive) in 20 women (6.8%). Nonoperative treatment plans changed in 40 of 294 women (14%). Urodynamic study driven treatment plan changes were not associated with treatment success (OR 0.96, 95% CI 0.41, 2.25, p = 0.92) but they were associated with increased postoperative treatment for urge urinary incontinence (OR 3.23, 95% CI 1.46, 7.14, p = 0.004)., Conclusions: Urodynamic studies significantly changed clinical diagnoses but infrequently changed the global treatment plan or influenced surgeon decision to cancel, change or modify surgical plans. Global treatment plan changes were associated with increased treatment for postoperative urgency urinary incontinence., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Longer term comparative efficacy information regarding transobturator and retropubic mid urethral slings is needed. We report 24-month continence rates, complications and symptom outcomes from a randomized equivalence trial., Materials and Methods: Primary outcomes were objective (negative stress test, negative pad test and no re-treatment for stress urinary incontinence) and subjective (no self-report of stress urinary incontinence symptoms, no leakage episodes on 3-day bladder diary and no re-treatment for stress urinary incontinence) success at 24 months. The predetermined equivalence margin was ± 12%., Results: Of 597 randomized participants 516 (86.4%) were assessed. Objective success rates for retropubic and transobturator mid urethral slings were 77.3% and 72.3%, respectively (95% CI for difference of 5.1% was -2.0, 12.1), and subjective success rates were 55.7% and 48.3%, respectively (CI for difference of 7.4% was -0.7, 15.5). Neither objective nor subjective success rates met the prespecified criteria for equivalence. Patient satisfaction (retropubic 86.3% vs transobturator 88.1%, p = 0.58), frequency of de novo urgency incontinence (retropubic 0% vs transobturator 0.3%, p = 0.99) and occurrence of mesh exposure (retropubic 4.4% vs transobturator 2.7%, p = 0.26) were not significantly different. The retropubic mid urethral sling group had higher rates of voiding dysfunction requiring surgery (3.0% vs 0%, p = 0.002) and urinary tract infections (17.1% vs 10.7%, p = 0.025), whereas the transobturator group had more neurological symptoms (9.7% vs 5.4%, p = 0.045)., Conclusions: Objective success rates met the criteria for equivalence at 12 months but no longer met these criteria at 24 months. Subjective success rates remained inconclusive for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved. Continued surveillance is important in women undergoing mid urethral sling surgery., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: To compare quality of life (QoL) and factors associated with QoL change after retropubic (RMUS) and transobturator midurethral slings (TMUS) using the Incontinence Impact Questionnaire (IIQ) and the International Consultation on Incontinence Questionnaire (ICIQ)., Methods: Five hundred ninety-seven women in a multicenter randomized trial of RMUS versus TMUS were examined. The IIQ and the ICIQ were obtained at baseline and at 12 and 24 months. Repeated-measures analysis of variance tested for differences by treatment group over time. Multivariable analysis identified factors associated with QoL change at 12 months postoperative, controlling for treatment group and baseline QoL., Results: Improvement in IIQ was associated with the following: treatment success, younger age, improvement in stress urinary incontinence (SUI) symptom severity, and bother (all P < 0.05). Improvement in ICIQ was associated with treatment success, younger age, improvement in SUI symptom severity and bother, lower body mass index, and no reoperation (all P < 0.05). Improvement of the IIQ was stable over time (P = 0.35) for both treatment groups (P = 0.66), whereas the ICIQ showed a small but clinically insignificant decline (P = 0.03) in both treatment groups (P = 0.51)., Conclusions: Postoperative QoL was improved after RMUS and TMUS. Measures of QoL functioned similarly, although more surgically modifiable urinary incontinence factors predicted improvement with the IIQ.

Purpose: We examined preoperative and postoperative patient related factors associated with continence status up to 7 years after surgery for stress urinary incontinence., Materials and Methods: Women randomized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence 2 years after surgery were eligible to enroll in a prospective observational study. Survival analysis was used to investigate baseline and postoperative factors in the subsequent risk of stress urinary incontinence, defined as self-report of stress urinary incontinence symptoms, incontinence episodes on a 3-day diary or surgical re-treatment., Results: Of the women who participated in the randomized trial 74% (482 of 655) were enrolled in the followup study. Urinary continence rates decreased during a period of 2 to 7 years postoperatively from 42% to 13% in the Burch group and from 52% to 27% in the sling group, respectively. Among the baseline factors included in the first multivariable model age (p = 0.03), prior stress urinary incontinence surgery (p = 0.02), menopausal status (0.005), urge index (0.006), assigned surgery (p = 0.01) and recruiting site (p = 0.02) were independently associated with increased risk of incontinence. In the final multivariable model including baseline and postoperative factors, Burch surgery (p = 0.01), baseline variables of prior urinary incontinence surgery (p = 0.04), menopausal status (p = 0.03) and postoperative urge index (p <0.001) were each significantly associated with a greater risk of recurrent urinary incontinence., Conclusions: Preoperative and postoperative urgency incontinence symptoms, Burch urethropexy, prior stress urinary incontinence surgery and menopausal status were negatively associated with long-term continence rates. More effective treatment of urgency urinary incontinence in patients who undergo stress urinary incontinence surgery may improve long-term overall continence status., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes., Methods: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points., Results: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes., Conclusions: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Objective: To identify urodynamic changes that correlate with successful outcomes after stress urinary incontinence (SUI) surgery., Methods: Six-hundred fifty-five women were randomized to Burch colposuspension or autologous fascial sling as part of the multicenter Stress Incontinence Surgical Treatment Efficacy Trial. Preoperatively and 24 months after surgery, participants underwent standardized urodynamic testing that included noninvasive uroflowmetry, cystometrogram, and pressure flow studies. Changes in urodynamic parameters were correlated to a successful outcome, defined a priori as (1) negative pad test; (2) no urinary incontinence on 3-day diary; (3) negative cough and Valsalva stress test; (4) no self-reported SUI symptoms on the Medical, Epidemiologic and Social Aspects of Aging Questionnaire; and (5) no re-treatment for SUI., Results: Subjects who met criteria for surgical success showed a greater relative increase in mean Pdet@Qmax (baseline vs 24 months) than women who were considered surgical failures (P = .008). Although a trend suggested an association between greater increases in bladder outlet obstruction index and outcome success, this was not statistically significant. Other urodynamic variables, such as maximum uroflow, bladder compliance, and the presence of preoperative or de novo detrusor overactivity did not differ with respect to outcome status., Conclusions: Successful outcomes in both surgical groups (Burch and sling) were associated with higher voiding pressures relative to preoperative baseline values. However, concomitant changes in other urodynamic voiding parameters were not significantly associated with outcome., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: To characterize the urodynamic (UDS) changes in subjects 24 months after Burch urethropexy and autologous fascial sling surgery for stress urinary incontinence., Methods: In the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), 655 women underwent standardized UDSs before and 2 years after Burch or sling surgery. Paired t tests were used to compare the pre- and postoperative UDS measures by treatment group. Analysis of variance models were fit predicting the change in UDS measures, controlling for the treatment group., Results: The noninstrumented maximal flow rate decreased 3.6 mL/s in the Burch group and 4.7 mL/s in the sling group (P = .42). The average flow rates also decreased (2.4 mL/s in the Burch group and 3.8 mL/s in the sling group, P = .039). No difference was found in the increases in first sensation between the Burch and sling groups (23.3 and 29.3 mL, respectively, P = .61). Also, no differences were found in the reduction in the pressure flow study maximal flow rates (2.3 mL/s in the Burch group and 4.4 mL/s in the sling group, P = .11). An increased detrusor pressure at maximal flow rate (11.4 cm H(2)O, P < .001) was seen only after the sling procedure. Increases in the bladder outlet obstruction index occurred after both procedures, with greater increases seen after sling surgery (change, Burch +6.27 vs sling +20.12, P = .001)., Conclusion: The Burch colposuspension and autologous fascial sling procedures were associated with similar decreases in noninstrumented flow rates, and the sling was associated with greater increases in the detrusor pressure at maximal flow rate and bladder outlet obstruction index. These changes suggest that both procedures are effective, in part, because of increased outlet resistance. However, the sling procedure might be more obstructive., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: To describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings., Study Design: During the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications., Results: A total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups., Conclusion: Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Objective: To identify clinical and demographic factors predictive of midurethral sling failure., Methods: Overall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or retreatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire, incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure and subjective failure only., Results: Previous UI surgery (odds ratio [OR] 1.99, 95% confidence interval [CI] 1.14-3.47); maximum Q-tip excursion<30° (OR 1.89, 95% CI 1.16-3.05); Medical, Epidemiologic and Social Aspect of Aging questionnaire urge score per 10 points (OR 1.97, 95% CI 1.21-3.21); and pad weight per 10 g (OR 1.06, 95% CI 1.02-1.10) were predictors of overall failure. Having concomitant surgery (OR 0.44, 95% CI 0.22-0.90) was predictive of subjective failure only rather than objective failure. Age per 10 years (OR 1.48, 95% CI 1.14-1.90); Urogenital Distress Inventory score per 10 points (OR 1.09, 95% CI 1.02-1.17); pad weight per 10 g (OR 1.05, 95% CI 1.01-1.10) were predictive of objective failure compared with subjective failure only. Associations of risk factors and failure were similar independent of sling type (retropubic or transobturator)., Conclusion: Twelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure., Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039., Level of Evidence: II.

Purpose: We determined the association of clinicodemographic factors with urinary incontinence related quality of life in women undergoing surgery for stress urinary incontinence, and compared the incontinence specific Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. Secondary objectives were to evaluate the contributions of incontinence severity and sexual function on quality of life., Materials and Methods: We used baseline data on 597 women in the Trial of Mid-Urethral Slings. Tested quality of life correlates included health status and history, sexual function, and urinary incontinence type, severity and bother., Results: On each questionnaire lower quality of life was associated with younger age, higher body mass index, more stress urinary incontinence symptoms, and more severe and bothersome urinary incontinence symptoms. Each measure identified factors associated with lower quality of life that were not identified by the other, including Hispanic ethnicity, poor health status and more urge urinary incontinence symptoms on the Incontinence Impact Questionnaire, and prior urinary incontinence treatment and more urinary incontinence episodes daily on the International Consultation on Incontinence Questionnaire. Sexually active women had similar quality of life as well as increased incontinence episodes on each questionnaire and more sexual dysfunction on the Incontinence Impact Questionnaire only., Conclusions: In women planning stress urinary incontinence surgery quality of life is associated with nonurinary incontinence factors, and with the type, severity and degree of urinary incontinence symptom bother. Many factors are associated with quality of life as measured by the Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. However, more nonurinary incontinence factors were associated with quality of life when measured by the former than by the latter. More than 1 scale may be needed to evaluate quality of life after treatment for stress urinary incontinence., (Copyright © 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: To identify predictors and correlates of patient satisfaction 24 months after Burch colpopexy or autologous fascial sling for treatment of stress urinary incontinence (SUI)., Methods: Participants were the 655 randomized subjects in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Variables potentially associated with satisfaction were tested in bivariate analysis, including demographics, baseline clinical characteristics of incontinence, and outcomes on validated subjective and objective measures. Satisfaction with treatment was defined as a response of "completely satisfied" or "mostly satisfied" on the Patient Satisfaction Questionnaire (PSQ) at 24 months. Variables significantly related to satisfaction were entered into multivariable regression models to test their independent association with satisfaction., Results: At 24 months post-surgery, 480 (73%) participants completed the PSQ. Mean (±SD) age of the sample was 52 (±10) years and 77% were white. Most (82%) were completely or mostly satisfied with their surgery related to urine leakage. In the final multivariable model, patient satisfaction was associated with greater reduction in SUI symptoms (from baseline to 24 months; OR = 1.17, 95% CI: 1.10, 1.24) and greater reductions in symptom distress (OR = 1.16; CI: 1.08, 1.24). Lower odds of satisfaction were associated with greater urge incontinence symptoms at baseline (OR = 0.09, CI: 0.04, 0.22), detrusor overactivity at 24 months (OR = 0.29, CI: 0.12, 0.69), and a positive stress test at 24 months (OR = 0.45, CI: 0.22, 0.91)., Conclusions: Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact., (© 2010 Wiley-Liss, Inc.)

Background: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications., Methods: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points., Results: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life., Conclusions: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.), (2010 Massachusetts Medical Society)

A 5-year ongoing, controlled multicenter study enrolled 150 women. Outcome measures included pad weight tests (PWT), voiding diary (VD), quality of life (QOL) and satisfaction questionnaires. Outcome measures during the baseline period were compared to evaluations during follow-up. Concurrent evaluations with and without device use were also performed. Safety evaluations included urinalysis and culture, leak-point pressure (LPP) and cystoscopy. Adverse events (AE) were recorded throughout the study. One to 2 years of follow-up were collected on all study participants (mean 15 months). Statistically significant reductions in overall daily incontinence episodes (P<0.001) and PWT urine loss (P<0.001) were observed with the device at all follow-up intervals, and 93% of women had a negative PWT at 12 months. Women were satisfied with ease of use of the device, comfort and dryness, and significant improvements in QOL were observed (P<0.001). Subgroup analysis revealed that the insert was effective, despite the presence of urgency, low LPP, failed surgery and advanced age. AE included symptomatic urinary tract infection in 31.3%, mild trauma with insertion in 6.7%, hematuria in 3.3%, and migration in 1.3% of women. The results of PWT and VD demonstrated device efficacy. Women were satisfied and significant improvements in QOL were observed. AE were transient and required minimal or no treatment. The urethral insert should be considered as an option for the management of SUI.

Objectives: To assess the safety and effectiveness of Durasphere compared with bovine collagen in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD)., Methods: This multicenter, randomized, controlled, double-blind trial was composed of 355 women diagnosed with SUI due to ISD and used a standardized pad test and the Stamey continence grade as the primary endpoints. The participants' ages ranged from 26 to 84 years. All patients had an abdominal leak point pressure of less than 90 cm H(2)O (average 51)., Results: At 12 months after the first injection, the two materials were equivalent with respect to the improvement in continence grade and pad weight testing. Less Durasphere was injected to obtain comparable clinical results (Durasphere 4.83 mL versus bovine collagen 6.23 mL, P <0.001). When examined 1 year after the date of the last treatment, 49 (80.3%) of the 61 women treated with Durasphere showed improvement of 1 continence grade or more compared with 47 (69.1%) of 68 women treated with bovine collagen (P value for difference = 0.162). Although the adverse events reported for both groups were similar, the Durasphere group had an increased short-term risk of urgency and urinary retention., Conclusions: The use of Durasphere for the treatment of SUI due to ISD was equally effective as bovine collagen and used less material. The U.S. Food and Drug Administration granted market approval for Durasphere on September 13, 1999. The product design and initial clinical data suggest the potential for greater durability of the clinical benefit, with the possibility of a permanent solution for SUI due to ISD in some patients.

Urinary incontinence is abnormal at any age. The prevalence of urinary incontinence increases with age due to functional impairments and concurrent medical disease. A detailed history and physical is essential in evaluating these patients. Urinary incontinence is treatable in all age groups when a logical, multifactorial and persistent approach is undertaken.

Objectives: To assess the efficacy of high-energy visual laser ablation of the prostate (VLAP) in men with urinary retention, using subjective and objective data., Methods: Seventeen men in urinary retention underwent high-energy VLAP. The mean patient age was 69 years, and the mean follow-up was 12 months. All men were urodynamically obstructed by pressure-flow analysis with a functioning detrusor muscle. Interviews assessed retrograde ejaculation and patient satisfaction., Results: The mean total energy applied was 71,088 J (range 27,556 to 110,294). The mean peak noninvasive urine flow rates increased from 2.1 to 18.1 cc/s, and the mean postvoid residual volumes decreased from 550.0 to 39.0 cc. The mean detrusor pressure at peak flow decreased from 66.4 to 41.9 cm H2O, and the mean maximal detrusor pressure decreased from 72.2 to 49.2 cm H2O. Ten men (59%) voided to completion within 1 week post-VLAP. The mean postoperative International Prostate Symptom Score was 6. Nine men (53%) reported new retrograde ejaculation, and 14 men (82%) were satisfied with their outcome., Conclusions: High-energy VLAP is an effective procedure for relief of bladder-outlet obstruction in men with urinary retention.

The objective of this study is to assess whether subjective information from the American Urological Association (AUA) Symptom 7 Index correlates with or predicts objective urodynamic parameters of bladder outlet obstruction. Seventy-five men, mean age 67 years (range 42-85 years), were referred for evaluation of "prostatism." Evaluation consisted of the AUA Symptom 7 Index, noninvasive uroflow, post-void residual (PVR) urine measurement, and pressure-flow analysis. Men were categorized as "obstructed," "equivocal," or "unobstructed" according to pressure-flow nomogram of Abrams and Griffiths. The total AUA 7 score, and all individual components, were compared with all invasive urodynamic parameters, and to the pressure-flow categories of obstructed, equivocal, or unobstructed. The AUA index severity categories (mild 0-7, moderate 8-19, and severe > or = 20) were compared to the urodynamic pressure flow categories. Thirty-three men had severe symptoms, and 42 had moderate or mild symptoms. Forty men were urodynamically obstructed, and 35 men were equivocal or unobstructed. There was no correlation of any AUA index parameter (total symptom score, obstructive or irritative score component, or any individual question) with any noninvasive urodynamic parameter. The sensitivity and specificity of the AUA index for urodynamic obstruction was 42.5% and 54.3% respectively. Multivariable logistic regression analysis was used to determine whether clinical data easily obtained in the office setting (age, PVR, noninvasive maximum and average flow rates) could predict urodynamic obstruction when combined with any component of the AUA index. Only age was found to be a significant predictor of obstruction status (P = 0.026). Subjective information from the AUA Symptom 7 Index does not correlate with objective data assessing bladder outlet obstruction. Though the AUA index is a valid clinical tool, it should not be used to gauge the presence or severity of bladder outlet obstruction.

Purpose: We compared surgical results in a cohort of women after modified Pereyra bladder neck suspension using questionnaire based outcomes analysis versus a retrospective chart review., Materials and Methods: Of 151 patients who underwent modified Pereyra bladder neck suspension 102 had complete questionnaire and chart data for review. Mean patient age was 56 years and followup was 25 months., Results: According to outcomes analysis 48 patients (47.1%) were cured and in 65 (64%) stress urinary incontinence improved compared to 74 (72%) cured and 89 (89%) improved by retrospective review. Of the 102 chart review patients 10 (9%) reported daily pad use compared to 55 of the 102 (53%) in the questionnaire study., Conclusions: This study controls for patient selection, definition of cure and length of followup, and demonstrates that study methodology profoundly affects reported outcomes for the modified Pereyra bladder neck suspension.

Eosinophilic cystitis is a rare form of an allergic cystitis. Factors such as food allergens, parasites, and drugs have been implicated in the genesis of eosinophilic cystitis. Associated risk factors include bronchial asthma, atopic diseases, and environmental allergens. Intravesical mitomycin is a reported causative agent. We report the first case of eosinophilic cystitis that developed after intravesical instillation of thiotepa for treatment of superficial bladder cancer.