A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

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.

Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women.

Background: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objective: To assess the efficacy of mechanotherapy provided by the Flyte® intra-vaginal device during pelvic floor muscle training (PFMT). Design: This was a randomized, controlled, double-blinded trial. Materials and methods: Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Results: Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks (p = <0.0001), with further reduction from 6 to 12 weeks (p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Conclusion: Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Trial registration: Registered on ClinTrials.gov (NCT02954042).

Novel mechanical stimulation therapy for stress urinary incontinence Stress urinary incontinence is the involuntary loss of urine during activities such as sneezing, coughing, lifting and exercise. It negatively affects quality of life, and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Pelvic floor muscle training, sometimes referred to as Kegel exercise, is the usual initial therapy to treat stress urinary incontinence. This study assessed the effectiveness and safety of the two types of mechanical stimulation therapy provided by the Flyte® intra-vaginal wand during pelvic floor muscle training. The first type stretches the muscles to optimize the effect of the pelvic floor muscle exercises. The second type is the delivery of specially tuned mechanical pulses that trigger muscle cell and tissue responses that accelerate muscle cell healing, increase muscle awareness and improve coordination. Due to an inadequate number of study subjects in the two study arms, the study data were combined into one analysis group to better assess the benefits of Flyte therapy in the participants. The volume of urine loss was very significantly reduced at 6-weeks, with further reduction from 6-12 weeks. Data were then divided into subgroups based on the severity of urine loss at the beginning of the study. Very significant reductions were noted in women with Mild, Moderate and Severe incontinence. Quality of life was similarly improved at 6 and 12 weeks, as measured by two quality of life questionnaires. These improvements were noted in as little as 2 weeks. More than 80% of participants performed the therapy at 6 weeks and 70% at 12 weeks. Improved quality of life was sustained through two years after the study ended in women who voluntarily continued participation in the study.

Ecological momentary assessment of pelvic pain and urinary urgency variability in urologic chronic pelvic pain syndrome and their association with illness impact and quality of life: Findings from the multidisciplinary approach to the study of chronic pelvic pain symptom patterns study.

PURPOSE: This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). MATERIALS AND METHODS: A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. RESULTS: A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. CONCLUSIONS: PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.

The impact of sacrospinous ligament fixation on pre-existing nocturia and co-existing pelvic floor dysfunction symptoms.

INTRODUCTION AND HYPOTHESIS: To evaluate whether nocturia and coexisting pelvic floor symptoms in women with pelvic organ prolapse (POP) can be improved by ligamentous fixation of apical vaginal prolapse to the sacrospinous ligament. METHODS: We evaluated the PROPEL study data from 281 women with pelvic organ prolapse stage > 2. Bothersome nocturia and coexisting pelvic floor symptoms were assessed with the Pelvic Floor Disorder Inventory (PFDI) questionnaire preoperatively and at 6, 12 and 24 months after successful vaginal prolapse repair. Women with successful reconstruction (POP-Q stage < 1 at all compartments throughout the 2-year follow-up), defined as anatomical "responders," were compared to the anatomical "non-responders." RESULTS: Among the patients completing all PFDI questions (N = 277), anatomical responders and non-responders were the groups of interest for our analysis. We found the occurrence rates of "moderate" or "quite a bit" of nocturia was significantly reduced after surgery in all subgroups (48.7% at baseline vs. 19.5% after 24 months). The occurrence of nocturia was halved for responders compared to non-responders (45.4% and 48.3% at baseline vs. 14% and 29.5% after 24 months). Anatomical non-responders still had a relevant improvement of POP-Q stages, especially in the apical compartment. Prevalence rates of co-existing over- and underactive bladder, fecal incontinence, defecation disorders and pain symptoms were also significantly reduced postoperatively. CONCLUSION: Nocturia can be associated with symptomatic POP, with improvements seen following vaginal ligamentous prolapse repair. We caution providers, however, when advising patients of the possible resolution of nocturia following POP reconstruction, that all other traditional etiologies of nocturia must first be ruled out.

Women in Leadership in Urology: The Case for Increasing Diversity and Equity.

There is a persistent male gender predominance in urology, especially with respect to female representation in leadership. We review the current status of women in urology leadership, discuss challenges women face in leadership positions, present the case for adopting inclusive practices that increase diversity and gender equity in urology leadership, and review the potential benefits of such an expansion. We discuss practical strategies to grow the role of women in urologic leadership, including increasing mentorship, modifying academic promotion criteria, and addressing implicit bias, while presenting a roadmap toward achieving equity and diversity at the highest ranks of urologic leadership.

Treatment of urethral stricture disease in women: A multi-institutional collaborative project from the SUFU research network.

AIM: Female urethral stricture disease is rare and has several surgical approaches including endoscopic dilations (ENDO), urethroplasty with local vaginal tissue flap (ULT) or urethroplasty with free graft (UFG). This study aims to describe the contemporary management of female urethral stricture disease and to evaluate the outcomes of these three surgical approaches. METHODS: This is a multi-institutional, retrospective cohort study evaluating operative treatment for female urethral stricture. Surgeries were grouped into three categories: ENDO, ULT, and UFG. Time from surgery to stricture recurrence by surgery type was analyzed using a Kaplan-Meier time to event analysis. To adjust for confounders, a Cox proportional hazard model was fit for time to stricture recurrence. RESULTS: Two-hundred and ten patients met the inclusion criteria across 23 sites. Overall, 64% (n = 115/180) of women remained recurrence free at median follow-up of 14.6 months (IQR, 3-37). In unadjusted analysis, recurrence-free rates differed between surgery categories with 68% ENDO, 77% UFG and 83% ULT patients being recurrence free at 12 months. In the Cox model, recurrence rates also differed between surgery categories; women undergoing ULT and UFG having had 66% and 49% less risk of recurrence, respectively, compared to those undergoing ENDO. When comparing ULT to UFG directly, there was no significant difference of recurrence. CONCLUSION: This retrospective multi-institutional study of female urethral stricture demonstrates that patients undergoing endoscopic management have a higher risk of recurrence compared to those undergoing either urethroplasty with local flap or free graft.

A longitudinal analysis of urological chronic pelvic pain syndrome flares in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

OBJECTIVE: To describe the frequency, intensity and duration of urological chronic pelvic pain syndrome symptom exacerbations ('flares'), as well as risk factors for these features, in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Epidemiology and Phenotyping longitudinal study. PARTICIPANTS AND METHODS: Current flare status ('urological or pelvic pain symptoms that are much worse than usual') was ascertained at each bi-weekly assessment. Flare characteristics, including start date, and current intensity of pelvic pain, urgency and frequency (scales of 0-10), were assessed for participants' first three flares and at three randomly selected times when they did not report a flare. Generalized linear and mixed effects models were used to investigate flare risk factors. RESULTS: Of the 385 eligible participants, 24.2% reported no flares, 22.9% reported one flare, 28.3% reported 2-3 flares, and 24.6% reported ≥4 flares, up to a maximum of 18 during the 11-month follow-up (median incidence rate = 0.13/bi-weekly assessment, range = 0.00-1.00). Pelvic pain (mean = 2.63-point increase) and urological symptoms (mean = 1.72) were both significantly worse during most flares (60.6%), with considerable within-participant variability (26.2-37.8%). Flare duration varied from 1 to 150 days (94.3% within-participant variability). In adjusted analyses, flares were more common, symptomatic, and/or longer-lasting in women and in those with worse non-flare symptoms, bladder hypersensitivity, and chronic overlapping pain conditions. CONCLUSION: In this foundational flare study, we found that pelvic pain and urological symptom flares were common, but variable in frequency and manifestation. We also identified subgroups of participants with more frequent, symptomatic, and/or longer-lasting flares for targeted flare management/prevention and further study.

Can surgical reconstruction of vaginal and ligamentous laxity cure overactive bladder symptoms in women with pelvic organ prolapse?

OBJECTIVE: To examine the extent and intensity of the coexistence of overactive bladder (OAB) symptoms in women with pelvic organ prolapse (POP) and to evaluate the likelihood of OAB symptom improvement after surgical POP reconstruction over a period of 2 years. PATIENTS AND METHODS: The effectiveness of the transvaginal, single-incision 'Elevate' technique for anatomical cure of anterior/apical and posterior/apical vaginal prolapse has been previously reported in a prospective, multicentre study. This technique uses mesh arms attached to the sacrospinous ligaments to recreate apical ligamentous support. Using the same sample population as that used in the multicentre study (n = 281), we conducted the present sub-analysis focusing on estimating the extent of comorbidity between POP and OAB symptoms, as well as the effects of subsequent pelvic floor reconstruction on OAB symptoms over a long period. Assessments of POP and OAB symptom severity before and after surgery at 6, 12 and 24 months were obtained using the Pelvic Floor Distress Inventory (PFDI) questionnaire. RESULTS: Preoperatively, 70% of all POP patients reported moderate to severe OAB symptoms, with almost half (49.5%) noting severe OAB bother ('quite a bit bothersome') for one or more of the classic OAB symptom domains on the PFDI: 'daytime urinary frequency'; 'urinary urgency'; 'urinary urgency incontinence'; and/or 'nocturia'. In fact, across all four OAB symptom domains evaluated, there were significantly more severe symptoms ('quite a bit bothersome') than moderate ('moderately bothersome') or mild ('somewhat bothersome'): 26-31%, 13-21%, and 17-19% of patients, respectively. In patients with symptomatic POP >stage 2, there was no relationship between further degree of prolapse and presence of severity of OAB symptoms; however, patients with POP stage 2 had significantly more complaints regarding the items 'daytime urinary frequency' and 'urinary urgency incontinence' compared with those with stage 3-4 POP. Pelvic floor reconstructive surgery resulted in significant improvement in all OAB symptoms, which seemed to be stable over time. The cure rate of moderate-to-severe OAB complaints ranged between 60% and 80%, which was a durable improvement noted throughout 24 months. CONCLUSION: Results showed that POP was to a high degree accompanied by moderate-to-severe OAB complaints. Significant long-lasting improvements in bothersome OAB symptoms occurred after adequate surgical reconstruction of anterior/apical and posterior/apical vaginal support.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation.

PURPOSE: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. MATERIALS AND METHODS: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. RESULTS: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). CONCLUSIONS: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

Urinary Catheter Management for Nonurologists: A Resident Driven Educational Initiative.

INTRODUCTION: Prevention of catheter associated urinary tract infection relies on timely catheter removal and care of indwelling catheters. Educational and quality improvement initiatives to prevent catheter associated urinary tract infection should address the basics of urinary catheter placement and management. Internal medicine residents are an appropriate target for these efforts and they may lack formal training in these issues. We developed a resident driven orientation session that covers basic Foley catheter management principles called the TIPS (Troubleshooting, Indications and Practice Sessions) program. METHODS: Urology residents at our institution were queried on common consultations for urinary catheter related issues. The incoming intern internal medicine class at our institution completed a pre-TIPS survey that evaluated their baseline urological experience and knowledge. A 1-hour didactic session led by urology residents was followed by hands-on directed practice with mannequins. The web based survey was repeated 1 month later. RESULTS: Of the total of 60 residents 54 (90%) completed the initial survey. In medical school 38 of 54 residents (70%) had never rotated in urology. Upon repeating the survey at 1 month the response rate was 34 of 60 residents (57%). The proportion of residents confident in their ability to troubleshoot catheter problems increased from 50% to 88% (p <0.05). Knowledge of indications, clot retention and proper catheter technique also improved (p <0.05). CONCLUSIONS: A focused educational session about common urological catheter management scenarios resulted in improved internal medicine resident confidence in catheter troubleshooting and knowledge of basic urinary catheter placement indications. These educational sessions may be a method to improve nonurology resident education and awareness of common urological issues.

Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation.

OBJECTIVE: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included. METHODS: Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS: A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION: The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.

Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder.

AIMS: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. METHODS: Subjects with successful test stimulation received an SNM implant. Therapeutic success (≥50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects. RESULTS: Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 ± 2.7 leaks/day, UF subjects had 12.6 ± 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 ± 2.7 leaks/day; UF subjects had a mean reduction of 5.1 ± 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. CONCLUSIONS: This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications.

Elevate and Uterine Preservation: Two-Year Results.

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.

Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

AIMS: This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). METHODS: Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency-frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. RESULTS: Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. CONCLUSIONS: This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. © 2014 Wiley Periodicals, Inc.

The PISQ-IR: considerations in scale scoring and development.

INTRODUCTION: This paper provides a detailed discussion of the psychometric analysis and scoring of a revised measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). METHODS: Standard tools for evaluating item distributions, relationships, and psychometric properties were used to identify sub-scales and determine how the sub-scales should be scored. The evaluation of items included a nonresponse analysis, the nature of missingness, and imputation methods. The minimum number of items required to be answered and three different scoring methods were evaluated: simple summation, mean calculation, and transformed summation. RESULTS: Item nonresponse levels are low in women who are sexually active and the psychometric properties of the scales are robust. Moderate levels of item nonresponse are present for women who are not sexually active, which presents some concerns relative to the robustness of the scales. Single imputation for missing items is not advisable and multiple imputation methods, while plausible, are not recommended owing to the complexity of their application in clinical research. The sub-scales can be scored using either mean calculation or transformed summation. Calculation of a summary score is not recommended. CONCLUSION: The PISQ-IR demonstrates strong psychometric properties in women who are sexually active and acceptable properties in those who are not sexually active. To score the PISQ-IR sub-scales, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. A summary score should not be calculated.