Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse.

OBJECTIVE: To compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority. METHODS: This was a prospective, nonrandomized, parallel cohort, multi-center trial comparing transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events. Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba<0 and/or C<0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied. RESULTS: Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%, 90% CI -0.2% to 13.2%). Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair (P=.056). Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted (P=.009), with a propensity score-adjusted difference of 10.6% (90% CI 3.3-17.9%) in favor of transvaginal mesh. Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, a propensity score-adjusted difference of -4.3% (CI -12.3% to 3.8%). For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (-0.4%, 90% CI -2.7% to 1.9%). Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (-15.7%, 95% CI -24.0% to -7.5%). CONCLUSION: Transvaginal mesh repair for the treatment of anterior and/or apical vaginal prolapse was not superior to native tissue repair at 36 months. Subjective success, an important consideration from the patient-experience perspective, was high and not statistically different between groups. Transvaginal mesh repair was as safe as native tissue repair with respect to serious device-related and/or serious procedure-related adverse events. FUNDING SOURCE: This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01917968.

Neuromodulation.

Sacral neuromodulation (SNM) has been available in the United States for more than 20 years and is a guideline-recommended therapy by both the American Urological Association and the American Society of Colon and Rectal Surgeons, with proven long-term success for urinary urgency incontinence, urinary urgency frequency, nonobstructive urinary retention, and fecal incontinence. Initially the therapy involved a more invasive surgical approach that included a large cut down over the sacrum. This article reviews recent advancements in SNM therapy including updates in best practices for implant technique, technological innovations, and the new clinical literature relevant to contemporary practice.

Concomitant Sacral Neuromodulation and Gynecologic Surgery: A Single-Institution Experience.

AIMS: Sacral Neuromodulation (SNM) is a safe and minimally invasive treatment for urinary and fecal pelvic floor disorders (PFDs). With a high prevalence of women reporting multiple PFDs, knowledge regarding concomitant surgery may inform optimal patient care. Our literature search did not identify any published data on this topic, thus we sought to report our experience with concomitant SNM and gynecologic surgery. Our primary objective was to identify the rate of adverse events among cases. Secondarily, we reviewed the anesthetics used to identify potential associations when performing combined surgery. MATERIALS AND METHODS: This was retrospective case series of women undergoing SNM at a single academic center from 2012 to 2018. Cases were identified using current procedural terminology codes for SNM and common gynecologic procedures. These electronic medical records were reviewed to identify cases that occurred concomitantly in addition to obtaining demographics, adverse events, type of anesthesia, and overnight hospital stay. Descriptive data analysis was performed with Excel. RESULTS: Of 200 identified cases of SNM, 15 (7.5%) were concomitantly performed with another procedure. Most concomitant surgeries occurred with insertion of implantable pulse generator. Three minor adverse events occurred: two urinary tract infections and one occurrence of urinary retention. Eight (53%) cases were performed under general anesthesia while seven (46%) received monitored sedation. CONCLUSIONS: No serious adverse events or anesthesia-related complications were identified in this series. While general anesthesia was used more often, it was in accordance with our standard practice for the gynecologic procedures. This study supports the safety of concomitant gynecologic and SNM surgery.

Clinical implications of self-neglect among patients in community settings.

The consequences of self-neglect can be wide-reaching and devastating, not only for patients themselves but also for their wider community, including assisting health practitioners and social care staff. Supporting patients in the context of self-neglect requires extensive multi-agency collaboration in order to gain a full understanding and a workable management strategy for the individual. Because community nurses see patients in their own homes, they are well placed to identify and address self-neglect. This article explores the definition, signs and causes of self-neglect, with issues of particular relevance for community nursing staff. The understanding and assessment of mental capacity, which is often complex and challenging, is also discussed, as well as the involvement of the safeguarding team where necessary.

Sacral Nerve Stimulation as a Therapy for Patients With Refractory Voiding and Bowel Dysfunction.

Sacral nerve stimulation delivers nonpainful electrical pulses to the sacral nerves that modulate the reflexes that control the bladder, bowels, and pelvic floor musculature. This relatively simple procedure was generated to improve and restore function in patients with a variety of pelvic floor disorders. Currently this therapy is approved for use in patients with urgency urinary incontinence, urinary urgency-frequency, nonobstructive urinary retention, and fecal incontinence. This review includes the history of this treatment modality, explains the mechanism of action, and describes the procedure for implantation of this device. Additionally, advancements in this treatment over the past two decades and landmark literature to date regarding sacral nerve stimulation are reviewed. Current literature regarding off-label uses of this treatment modality for a variety of pelvic floor disorders is also discussed.

Baseline symptom severity and therapeutic success in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients.

INTRODUCTION: The InSite trial is a prospective, multicenter post-approval study of subjects receiving sacral neuromodulation (SNM) therapy with the InterStim® System. Enrolled subjects had bothersome symptoms of overactive bladder (OAB). The purpose of this analysis was to determine if severity of baseline symptoms had an impact on clinical outcomes. METHODS: For device implant, therapeutic success was defined as a ≥50% improvement in average leaks/day, or in voids/day or a return to normal voiding frequency. Groups were dichotomized into less versus more severe based on median number of leaks and voids. Subjects were grouped as less severe <2 leaks/day for UI; <11 voids/day for UF and more severe ≥2 leaks/day for UI; ≥11 voids/day for UF. Therapeutic success at 12 and 24 months were compared between groups. RESULTS: Three hundred and forty subjects completed test stimulation and 272 (80%) subjects received a full system implant. On average UI subjects had 1.3 leaks/day in the less severe group and 4.5 leaks/day in the more severe group. UI success rates were not statistically different between severity groups at 12 months or 24 months). At baseline, on average UF subjects had 9.4 voids/day for the less severe group and 15.1 voids/day for the more severe group. UF success rates were not statistically different between severity groups at 12 months or 24 months. CONCLUSION: Data evaluating efficacy based on symptom severity demonstrates that SNM is effective in treating both less severe and more severely affected groups for both UI and UF at 12 and 24 months.

International Continence Society best practice statement for use of sacral neuromodulation.

AIMS: Sacral neuromodulation (SNM) is an accepted therapy for a variety of conditions. However, despite over 20 years of experience, it remains a specialized procedure with a number of subtleties. Here we present the recommendations issued from the International Continence Society (ICS) SNM Consensus Panel. METHODS: Under the auspices of the ICS, eight urologists, three colorectal surgeons and two urogynecologists, covering a wide breadth of geographic and specialty interest representation, met in January 2017 to discuss best practices for neuromodulation. Suggestions for statements were submitted in advance and specific topics were assigned to committee members, who prepared and presented supporting data to the group, at which time each topic was discussed in depth. Best practice statements were formulated based on available data. This document was then circulated to multiple external reviewers after which final edits were made and approved by the group. RESULTS: The present recommendations, based on the most relevant data available in the literature, as well as expert opinion, address a variety of specific and at times problematic issues associated with SNM. These include the use of SNM for a variety of underlying conditions, need for pre-procedural testing, use of staged versus single-stage procedures, screening for success during the trial phase, ideal anesthesia, device implantation, post-procedural management, trouble-shooting loss of device function, and future directions for research. CONCLUSIONS: These guidelines undoubtedly constitute a reference document, which will help urologists, gynecologists, and colorectal surgeons optimize their use of SNM for refractory urinary urgency and frequency, UUI, NOR, and FI.

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.

Stimulation latency and comparison of cycling regimens in women using sacral neuromodulation.

AIMS: In this two-part study, we sought to define how long sacral neuromodulation users with overactive bladder should trial a new setting before attributing symptoms to that setting. Subsequently, we evaluated patient preferences of variable stimulation regimens. METHODS: In the initial phase of this prospective pilot study, participants' devices were turned off and later reactivated; time to symptom recurrence and resolution were recorded. In phase two, participants trialed four settings in a masked fashion with random order. After unmasking, participants chose their preferred setting and were followed 1 year. RESULTS: Twelve subjects completed phase one. With the device off, the mean time to symptom recurrence was 11.25 days. Mean time to symptom regression following reactivation was 6.42 days. Combined, the 90th percentile was 15 days for symptoms to reflect the device's new setting. Among 23 women completing part two, the most popular setting at the time of unmasking was a 1-hr on, 2-hr off cycled setting chosen by 7 (30%) participants. According to published estimates of battery longevity, 14 (61%) participants chose a more energy-conserving setting at the time of unmasking. The mean difference in estimated battery longevity between the chosen and baseline regimens was 14.5 months. These gains diminished in the following year with clinical changes in device settings by patients and providers. CONCLUSIONS: Sacral neuromodulation patients should allow a 2-week trial before attributing symptoms to a new setting. With additional information, many opt for energy-conserving settings. A 1-hr on, 2-hr off regimen warrants further study. Neurourol. Urodynam. 36:486-489, 2017. © 2016 Wiley Periodicals, Inc.

Cost profiles and budget impact of rechargeable versus non-rechargeable sacral neuromodulation devices in the treatment of overactive bladder syndrome.

OBJECTIVES: Sacral neuromodulation (SNM) is a guideline-recommended third-line treatment option for managing overactive bladder. Current SNM devices are not rechargeable, and require neurostimulator replacement every 3-6 years. Our study objective was to assess potential cost effects to payers of adopting a rechargeable SNM neurostimulator device. METHODS: We constructed a cost-consequence model to estimate the costs of long-term SNM-treatment with a rechargeable versus non-rechargeable device. Costs were considered from the payer perspective at 2015 reimbursement levels. Adverse events, therapy discontinuation, and programming rates were based on the latest published data. Neurostimulator longevity was assumed to be 4.4 and 10.0 years for non-rechargeable and rechargeable devices, respectively. A 15-year horizon was modeled, with costs discounted at 3% per year. Total budget impact to the United States healthcare system was estimated based on the computed per-patient cost findings. RESULTS: Over the 15-year horizon, per-patient cost of treatment with a non-rechargeable device was $64,111 versus $36,990 with a rechargeable device, resulting in estimated payer cost savings of $27,121. These cost savings were found to be robust across a wide range of scenarios. Longer analysis horizon, younger patient age, and longer rechargeable neurostimulator lifetime were associated with increased cost savings. Over a 15-year horizon, adoption of a rechargeable device strategy was projected to save the United States healthcare system up to $12 billion. CONCLUSIONS: At current reimbursement rates, our analysis suggests that rechargeable neurostimulator SNM technology for managing overactive bladder syndrome may deliver significant cost savings to payers over the course of treatment. Neurourol. Urodynam. 36:727-733, 2017. © 2016 Wiley Periodicals, Inc.

Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients.

INTRODUCTION: The InSite trial is a prospective, multicenter study of sacral neuromodulation (SNM) therapy with the InterStim® System in subjects with overactive bladder (OAB). One of the primary aims of the study is to report on long-term safety of the tined lead. This analysis provides detailed descriptions of device-related adverse events (AEs) and surgical interventions to 12 months. METHODS: Analysis included those subjects who completed test stimulation with a tined lead, received a full implant, and reported device-related AEs out to 12 months. A Clinical Events Committee (CEC) adjudicated AEs to 12 months. RESULTS: Device-related AEs occurred in 30% (82/272) of subjects, with only one considered serious. Fifty-six percent of the device-related AEs occurred between implant and 3 months. The most frequent device-related AEs were undesirable change in stimulation (12%, 32/272); implant site pain (7%, 20/272); and implant site infection (3%, 9/272). Of the 26 events of implant site pain, 13 required surgical intervention, with only two resulting in explant. Ten subjects experienced 13 events of a surgical site infection (including an additional cellulitis), five of which resolved with antibiotics and eight required explantation. The overall surgical intervention rate was 13% with the most common reasons being pain at the surgical site (4%), lack/loss of efficacy (4%), and infection (3%). CONCLUSIONS: Although a 30% AE rate was reported, most AEs were minor and were resolved without surgical intervention. Surgical intervention was required in 13% of subjects, with the majority being revision or replacement. Neurourol. Urodynam. 36:1136-1139, 2017. © 2016 Wiley Periodicals, Inc.

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.

Neuromodulation and female pelvic disorders.

PURPOSE OF REVIEW: Sacral neuromodulation is a Food and Drug administration approved therapy for the treatment of refractory overactive bladder, urinary retention, and fecal incontinence. The objective of this manuscript is to review the recent literature regarding clinical outcome data and current management strategies for sacral neuromodulation. RECENT FINDINGS: There have been significant advances in therapy techniques as well as long-term data supporting this therapy for both urinary and fecal incontinence. These include the InSite trial and the long-term follow-up of the fecal incontinence registry trial. In addition, the development of surgical techniques to reduce infection, improvements in programmability of the implantable pulse generator, as well as deciding on best stimulation parameters will be discussed. Finally, introduction of a new animal model to test a chronically implanted lead and stimulator in a large animal model opens the door to many future studies. SUMMARY: These data help to inform us on the most recent clinical outcomes for sacral neuromodulation, as well as recommendations for best practices for implant technique.

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.

Prospective Randomized Crossover Trial Comparing Continuous and Cyclic Stimulation in InterStim Therapy.

OBJECTIVES: The aim of this study was to assess a difference in efficacy and patient preference in cyclic versus continuous stimulation with InterStim therapy for urge incontinence or urinary frequency. METHODS: Patients with refractory urge incontinence/urinary frequency and with recent implantation of the InterStim system were randomized to continuous or cyclic InterStim stimulation after institutional review board-approved consent. They completed a 3-day voiding diary after 1 month of stimulation. They were then switched to the alternative setting for 1 month and completed another voiding diary. Subjective responses were evaluated with the Urinary Incontinence Impact Questionnaire and the Urinary Distress Inventory. Patient preference of stimulation setting was assessed. Statistical analysis was performed with paired t tests and repeated-measures analysis of variance. RESULTS: Data were available for 32 patients. Indication for InterStim: urge incontinence = 24, frequency = 8. No differences were noted in the number of urgency or urge incontinence episodes (mild, moderate, severe, or total) with cyclic or continuous stimulation. No differences were noted in the number of number of pads per day or the number of daytime or nighttime voids. The Urinary Incontinence Impact Questionnaire and Urinary Distress Inventory symptoms scores showed no significant differences between cyclic and continuous stimulation. No significant difference was noted in measured parameters based on the order of stimulation. Continuous stimulation was preferred by 17 patients, 9 preferred cyclic stimulation, and 6 had no preference. CONCLUSIONS: No significant differences were noted in voiding diaries and subjective responses between cyclic and continuous stimulation in InterStim therapy for patients with urge incontinence or frequency.

Risk Factors for Surgical Site Infection in Patients Undergoing Sacral Nerve Modulation Therapy.

OBJECTIVES: The aim of this study was to identify risk factors for surgical site infection in patients undergoing sacral nerve modulation (SNM) surgery. METHODS: We conducted a retrospective cohort analysis of 290 patients undergoing a total of 669 SNM procedures between 2002 and 2012 by 2 fellowship-trained female pelvic medicine and reconstructive surgery attending physicians at the University of California-Irvine Medical Center. Infection was defined as a charted abnormal examination finding at the implantation site (erythema, induration, purulent discharge) resulting in prescription of antibiotics, hospitalization, or explantation. We extracted information from the medical record regarding possible risk factors for infection including age, body mass index, immunosuppression (diabetes mellitus, chronic steroid use, smoker, chemotherapy), number of procedures per patient, and number of days between stages 1 and 2. In addition, we compared infection rates before and after 2008 when a clinical practice change was made with the implementation of home chlorhexidine washing (CHW) prior to SNM surgery. RESULTS: Thirty infections occurred, 25 of which were managed with oral antibiotics. Nine required intravenous antibiotics, and 11 required removal of the implanted device. Three patients experienced infection on 2 separate occasions. Seventeen infections had culture data available. Nine of the patients who underwent explantation had wound cultures positive for methicillin-resistant Staphylococcus aureus.Thirteen of the 26 patients who developed infection had medical histories significant for immunosuppression. Three patients developed late-onset abscess formation at 234, 257, and 687 days after stage 2, respectively. The median time between the most recent SNM procedure and development of infection was 14 days (range, 6-88 days).Body mass index and immunosuppression were significant predictors of infection, whereas age, parity, indication for procedure, and number of days between stages 1 and 2 were not found to be independent predictors. Three hundred twenty-three procedures were performed prior to and 346 procedures were performed after institution of home CHW. Twenty-four (80%) of the 30 reported infections were prior to CHW, whereas only 6 infections (20%) occurred after this change in practice. Prior to institution of CHW, the infection rate was 7.4%, and after institution of CHW, it was 1.7% (P = 0.002). Of the 83 patients with compliance data available for CHW use, 71 reported using CHW, whereas 12 reported not using CHW. CONCLUSIONS: Surgical site infection is a significant risk of SNM surgery, although our infection rate is lower than previously reported. Chlorhexidine washing appears to reduce the risk of infection in this population. Because the majority of infections requiring explantation were methicillin-resistant S. aureus positive, prophylactic treatment for this organism should be considered as an additional strategy to reduce infection. Body mass index and immunosuppression appear to be independent risk factors for infection.

Comparison of location of mesh placed transvaginally vs mesh placed abdominally at the time of sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The location of mesh placed at the time of abdominal sacrocolpopexy (ASC) is hypothesized to be in the same location histologically as mesh placed via full-thickness vaginal dissection in a cadaver model. METHODS: Ten fresh frozen cadavers underwent mesh placement via traditional ASC. In the same specimen, a transvaginal mesh (TVM) procedure was performed, attempting a full-thickness dissection. A block section was excised from each area including full thickness of the vagina and bladder with the intervening mesh. This was analyzed by a blinded pathologist. RESULTS: All cadavers underwent successful placement of both transabdominal mesh and TVM. Of the abdominally placed meshes, 6 were located between the vagina and bladder, whereas 3 were situated within the vaginal wall, with an average depth of 0.30 mm. Five of the vaginal mesh pieces were placed between the bladder and vagina, and 4 within the vaginal wall at a depth of 0.25 mm. One specimen placed vaginally was 0.05 mm within the serosa of the bladder. One specimen could not be interpreted, despite multiple cuts. CONCLUSION: ASC and full-thickness vaginal dissection result in histologically similar locations. Dissection for ASC may only result in the correct plane between the bladder and vagina in approximately 60 % of cases. We achieved full-thickness dissection for the transvaginal approach in 50 % of the cases, with one small penetration into the bladder serosa. Using a full-thickness dissection technique for TVM may be one way of reducing mesh exposure rates in those seen with ASC.

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.

Validation of a bladder symptom screening tool in women with incontinence due to overactive bladder.

INTRODUCTION AND HYPOTHESIS: The Actionable Bladder Symptom Screening Tool (ABSST) was initially developed to identify patients with multiple sclerosis (MS) who could benefit from lower urinary tract assessment and treatment. Assessment of the measurement properties of the ABSST, including its ability to identify patients experiencing bladder symptoms related to overactive bladder (OAB), was undertaken in a general female population. METHODS: One hundred women completed the ABSST, OAB Questionnaire Short Form (OAB-q SF), and a patient global impression of severity (PGI-S) scale. Half of the sample had urgency urinary incontinence (UUI), while the other half did not. Descriptive statistics, reliability, and validity were examined, as was sensitivity and specificity of the previous cut-off score established in MS. RESULTS: Fifty-three women with UUI/OAB and 47 controls took part (71.0 % Caucasian). Patients with UUI/OAB were older (54.6 vs 40.4 years), had a higher body mass index (31.1 vs 26.4 kg/m(2)), and more comorbid conditions. The Cronbach's alpha reliability of ABSST was 0.90. High correlations with OAB-q SF Symptom Bother and Health Related Quality of Life (r = 0.83 and -0.81 respectively) supported concurrent validity. Using the PGI-S severity scores as a reference, the ABSST was able to distinguish patients with differing severity levels (known-group validity). Physician assessment of the need for further evaluation/treatment showed sensitivity (79 %) and specificity (98 %), supporting a cut-off score of ≥3. CONCLUSIONS: The previous MS ABSST scoring algorithm was validated in a non-neurogenic female population. ABSST is a reliable, valid, and sensitive tool for screening women with UUI/OAB.