Sacral neuromodulation device biofilm differs in the absence and presence of infection, harbors antibiotic resistance genes, and is reproducible in vitro.

INTRODUCTION/PURPOSE: Sacral neuromodulation (SNM) is effective therapy for overactive bladder refractory to oral therapies, and non-obstructive urinary retention. A subset of SNM devices is associated with infection requiring surgical removal. We sought to compare microbial compositions of explanted devices in the presence and absence of infection, by testing phase, and other clinical factors, and to investigate antibiotic resistance genes present in the biofilms. We analyzed resistance genes to antibiotics used in commercially-available anti-infective device coating/pouch formulations. We further sought to assess biofilm reconstitution by material type and microbial strain in vitro using a continuous-flow stir tank bioreactor, which mimics human tissue with an indwelling device. We hypothesized that SNM device biofilms would differ in composition by infection status, and genes encoding resistance to rifampin and minocycline would be frequently detected. MATERIALS/METHODS: Patients scheduled to undergo removal or revision of SNM devices were consented per IRB-approved protocol (IRB 20-415). Devices were swabbed intraoperatively upon exposure, with controls and precautions to reduce contamination of the surrounding field. Samples and controls were analyzed with next-generation sequencing and RT-PCR, metabolomics, and culture-based approaches. Associations between microbial diversity or microbial abundance, and clinical variables were then analyzed using t-tests and ANOVA. Reconstituted biofilm deposition in vitro using the bioreactor was compared by microbial strain and material type using plate-based assays and scanning electron microscopy. RESULTS: Thirty seven devices were analyzed, all of which harbored detectable microbiota. Proteobacteria, Firmicutes and Actinobacteriota were the most common phyla present overall. Beta-diversity differed in the presence versus absence of infection (p = 0.014). Total abundance, based on normalized microbial counts, differed by testing phase (p < 0.001), indication for placement (p = 0.02), diabetes mellitus (p < 0.001), cardiac disease (p = 0.008) and history of UTI (p = 0.008). Significant microbe-metabolite interaction networks were identified overall and in the absence of infection. 24% of biofilms harbored the tetA tetracycline/minocycline resistance gene and 53% harbored the rpoB rifampin resistance gene. Biofilm was reconstituted across tested strains and material types. Ceramic and titanium did not differ in biofilm deposition for any tested strain. CONCLUSIONS: All analyzed SNM devices harbored microbiota. Device biofilm composition differed in the presence and absence of infection and by testing phase. Antibiotic resistance genes including to rifampin and tetracycline/minocycline, which are used in commercially-available anti-infective pouches, were frequently detected. Isolated organisms from SNM devices demonstrated the ability to reconstitute biofilm formation in vitro. Biofilm deposition was similar between ceramic and titanium, materials used in commercially-available SNM device casings. The findings and techniques used in this study together provide the basis for the investigation of the next generation of device materials and coatings, which may employ novel alternatives to traditional antibiotics. Such alternatives might include bacterial competition, quorum-sensing modulation, or antiseptic application, which could reduce infection risk without significantly selecting for antibiotic resistance.

Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter?

Introduction: Intradetrusor onabotulinumtoxinA (Botox) injections, to treat idiopathic overactive bladder (OAB), can be performed in the office setting under local analgesia alone or in the operating room (OR) under local and/or sedation. The objective of this study was to compare the symptomatic improvement in patients with OAB who underwent treatment with intradetrusor onabotulinumtoxinA injections in an in-office versus the OR setting. Methods: We performed a multicenter retrospective cohort study of women with the diagnosis of refractory non-neurogenic OAB who elected to undergo treatment with intradetrusor onabotulinumtoxinA injections between January 2015 and December 2020. The electronic medical records were queried for all the demographic and peri-procedural data, including the report of subjective improvement post procedure. Patients were categorized as either "in-office" versus "OR" based on the setting in which they underwent their procedure. Results: Five hundred and thirty-nine patients met the inclusion criteria: 297 (55%) in the in-office group and 242 (45%) in the OR group. A total of 30 (5.6%) patients reported retention after their procedure and it was more common in the in-office group (8.1%) versus the OR group (2.5%), (P = 0.003). The rate of urinary tract infection within 6 months of the procedure was higher in the OR group (26.0% vs. 16.8%, P = 0.009). The overall subjective improvement rate was 77% (95% confidence interval: 73%-80%). Patients in the OR group had a higher reported improvement as compared to the in-office group (81.4% vs. 73.3%, P = 0.03). Conclusions: In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed.

Cognitive impairment does not impact sacral neuromodulation implant rates for overactive bladder.

OBJECTIVE: To evaluate the impact of cognitive impairment (CI) diagnoses on sacral neuromodulation (SNM) outcomes in older patients. MATERIALS AND METHODS: We completed a retrospective review of all patients aged ≥55 years who underwent test-phase SNM (peripheral nerve evaluation (PNE) or stage 1) for overactive bladder (OAB) between 2014 and 2021 within a large multi-regional health system. Patient demographics, relevant comorbidities, CI diagnoses (dementia or mild CI), and SNM procedures were recorded. Logistic regression modeling was performed to evaluate the impact of CI on SNM implantation rates. RESULTS: Five-hundred and ten patients underwent SNM test phase (161 PNE, 349 Stage 1) during the study period. The mean age was 71.0(8.5) years, and most (80.6%) were female. Overall, 52(10.1%) patients had a CI diagnosis at the time of SNM, and 30 (5.8%) were diagnosed at a median of 18.5 [9.25, 39.5] months after SNM. Patients with CI diagnoses were older, with more comorbidities, and were more likely to undergo PNE. Univariable comparison found no difference in implantation rate based on pre-SNM CI (85.4% vs. 76.9%, p = 0.16). Multivariable analysis identified PNE (OR 0.43, 95% CI 0.26-0.71), age (OR 0.96, 95%CI 0.93-0.98), and prior beta-3 agonist use (OR 0.60, 95% CI 0.37-0.99) but not CI or dementia as independent negative predictors of implantation. Implanted patients had a median follow-up of 25 [12.0, 55.0] months. Explant and revision rates did not differ according to CI. CONCLUSION: Patients with OAB and CI diagnoses proceed to SNM implant at rates similar to patients without CI diagnoses. A diagnosis of CI should not necessarily exclude patients from SNM therapy for refractory OAB.

Neural networks outperform expert humans in predicting patient impressions of symptomatic improvement following overactive bladder treatment.

INTRODUCTION AND HYPOTHESIS: The objective was to accurately predict patient-centered subjective outcomes following the overactive bladder (OAB) treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM) using a neural network-based machine-learning approach. In the context of treatments designed to improve quality of life, a patient's perception of improvement should be the gold standard outcome measure. METHODS: Cutting-edge neural network-based algorithms using reproducing kernel techniques were trained to predict patient-reported improvements in urinary leakage and bladder function as assessed by Patient Global Impression of Improvement score using the ROSETTA trial datasets. Blinded expert urologists provided with the same variables also predicted outcomes. Receiver operating characteristic curves and areas under the curve were generated for algorithm and human expert predictions in an out-of-sample holdout dataset. RESULTS: Algorithms demonstrated excellent accuracy in predicting patient subjective improvement in urinary leakage (OBTX-A: AUC 0.75; SNM: 0.80). Similarly, algorithms accurately predicted patient subjective improvement in bladder function (OBTX-A: AUC 0.86; SNM: 0.96). The top-performing algorithms outcompeted human experts across outcome measures. CONCLUSIONS: Novel neural network-based machine-learning algorithms accurately predicted OBTX-A and SNM patient subjective outcomes, and generally outcompeted expert humans. Subtle aspects of the physician-patient interaction remain uncomputable, and thus the machine-learning approach may serve as an aid, rather than as an alternative, to human interaction and clinical judgment.

Third-line therapy for overactive bladder in the elderly: Nuances and considerations.

INTRODUCTION: Overactive bladder (OAB) disproportionally affects older adults in both incidence and severity. OAB pharmacotherapy is often problematic in the elderly due to polypharmacy, adverse side effect profiles and contraindications in the setting of multiple comorbidities, and concerns regarding the risk of incident dementia with anticholinergic use. The burden of OAB in older patients coupled with concerns surrounding pharmacotherapy options should motivate optimization of nonpharmacologic therapies in this population. At the same time, several aspects of aging may impact treatment efficacy and decision-making. This narrative review critically summarizes current evidence regarding third-line OAB therapy use in the elderly and discusses nuances and treatment considerations specific to the population. METHODS: We performed an extensive, nonsystematic evidence assessment of available literature via PubMed on onabotulinumtoxinA (BTX-A), sacral neuromodulation, and percutaneous tibial nerve stimulation (PTNS) for OAB, with a focus on study in elderly and frail populations. RESULTS: While limited, available studies show all three third-line therapies are efficacious in older populations and there is no data to support one option over another. BTX-A likely has a higher risk of urinary tract infection and retention in older compared to younger populations, especially in the frail elderly. PTNS incurs the lowest risk, although adherence is poor, largely due to logistical burdens. CONCLUSION: Advanced age and frailty should not preclude third-line therapy for refractory OAB, as available data support their efficacy and safety in these populations. Ultimately, treatment choices should be individualized and involve shared decision-making.

Machine learning provides an accurate prognostication model for refractory overactive bladder treatment response and is noninferior to human experts.

OBJECTIVE: The increasing wealth of clinical data may become unmanageable for a physician to assimilate into optimal decision-making without assistance. Utilizing a novel machine learning (ML) approach, we sought to develop algorithms to predict patient outcomes following the overactive bladder treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM). MATERIALS AND METHODS: ROSETTA datasets for overactive bladder patients randomized to OBTX-A or SNM were obtained. Novel ML algorithms, using reproducing kernel techniques were developed and tasked to predict outcomes including treatment response and decrease in urge urinary incontinence episodes in both the OBTX-A and SNM cohorts, in validation and test sets. Blinded expert urologists also predicted outcomes. Receiver operating characteristic curves were generated and AUCs calculated for comparison to lines of ignorance and the expert urologists' predictions. RESULTS: Trained algorithms demonstrated outstanding accuracy in predicting treatment response (OBTX-A: AUC 0.95; SNM: 0.88). Algorithms accurately predicted mean decrease in urge urinary incontinence episodes (MSE < 0.15) in OBTX-A and SNM. Algorithms were superior to human experts in response prediction for OBTX-A, and noninferior to human experts in response prediction for SNM. CONCLUSIONS: Novel ML algorithms were accurate, superior to expert urologists in predicting OBTX-A outcomes, and noninferior to expert urologists in predicting SNM outcomes. Some aspects of the physician-patient interaction are subtle and uncomputable, and thus ML may complement, but not supplant, a physician's judgment.

Surgical management of vaginal prolapse: current surgical concepts.

INTRODUCTION Pelvic organ prolapse (POP) is a condition defined by a loss of structural integrity within the vagina and often results in symptoms which greatly interfere with quality of life in women. POP is expected to increase in prevalence over the coming years, and the number of patients undergoing surgery for POP is expected to increase by up to 13%. Two categories of surgery for POP include obliterative and reconstructive surgery. Patient health status, goals, and desired outcomes must be carefully considered when selecting a surgical approach, as obliterative surgeries result in an inability to have sexual intercourse postoperatively. MATERIALS AND METHODS: This review article covers the role of traditional native tissue repairs, surgical options and techniques for vaginal and abdominal reconstruction for POP and the associated complications, and considerations for prevention and management of post-cystectomy vaginal prolapse. RESULTS: Studies comparing native and augmented anterior repairs demonstrate better anatomic outcomes in patients with mesh at the cost of more surgical complications, while different procedures for posterior repair result in similar improvements in symptoms and quality of life. In the management of apical prolapse, vaginal obliterative repair, namely colpocleisis, results in very low risk of recurrence at the cost of the impossibility of having sexual intercourse postoperatively. Reconstructive procedures preserve vaginal length along with the ability to have intercourse, but show higher failure rates over time. They can be divided into vaginal approaches which include sacrospinous ligament fixation (SSLF) and uterosacral vaginal vault suspension (USVS), and the abdominal approach which primarily includes abdominal sacrocolpopexy (ASC). There is evidence that ASC confers a distinct advantage over vaginal approaches with respect to symptom recurrence, sexual function, and quality of life. Patients who have had radical cystectomy for bladder cancer are at an increased risk of POP, and may benefit from preventative measures and prophylactic repair during surgery. Importantly, the success rates of POP surgery vary depending on whether anatomic or clinical definitions of success are used, with success rates improving when metrics such as the presence of symptoms are incorporated. CONCLUSIONS: The surgical management of POP should greatly take into account the postoperative goals of every patient, as different approaches result in different sexual and quality of life outcomes. It is important to consider clinical metrics in the evaluation of success for POP surgery as opposed to using exclusively anatomic criteria. Preoperative counseling is critical in managing expectations and increasing patient satisfaction postoperatively.

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.

PURPOSE: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of non-neurogenic overactive bladder (OAB). MATERIALS & METHODS: The primary source of evidence for the original version of this guideline was the systematic review and data extraction conducted as part of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report/Technology Assessment Number 187 titled Treatment of Overactive Bladder in Women (2009). That report was supplemented with additional searches capturing literature published through December 2011. Following initial publication, this guideline underwent amendment in 2014 and 2018. The current document reflects relevant literature published through October 2018. RESULTS: When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low). Such statements are provided as Standards, Recommendations, or Options. In instances of insufficient evidence, additional guidance information is provided as Clinical Principles and Expert Opinions. CONCLUSIONS: The evidence-based statements are provided for diagnosis and overall management of OAB, as well as for the various treatments. Diagnosis and treatment methodologies can be expected to change as the evidence base grows and as new treatment strategies become obtainable.

Motor Response Matters: Optimizing Lead Placement Improves Sacral Neuromodulation Outcomes.

PURPOSE: We sought to determine the usefulness of motor responses during sacral neuromodulation lead placement by testing the hypothesis that a greater number of motor responses during intraoperative electrode testing would be associated with more durable therapy. MATERIALS AND METHODS: We retrospectively reviewed all sacral neuromodulation lead placements at a large academic center from 2010 to 2015. Included in study were all unilateral sacral lead placements for which the presence or absence of a motor response was documented discretely for each electrode. Motor responses were quantified into separate subscores, including bellows and toe response subscores (each range 0 to 4) for a possible maximum total score of 8 when combined. Revision surgery was the primary outcome. Univariate and multivariate analyses were performed for factors associated with lead revision. RESULTS: A total of 176 lead placements qualified for analysis. Mean ± SD cohort age was 58.4 ± 15.9 years, 86.4% of the patients were female and 93.2% had undergone implantation for overactive bladder. Median followup was 10.5 months (range 2 to 36). Overall 34 patients (19%) required lead revision. Revision was negatively associated with the total electrode response score (p = 0.027) and the toe subscore (p = 0.033) but not with the bellows subscore (p = 0.183). Predictors of revision on logistic regression included age less than 59 years at implantation (OR 5.5, 95% CI 2-14) and a total electrode response score less than 4 (OR 4.2, 95% CI 1.4-12.8). CONCLUSIONS: Fewer total electrode responses and specifically fewer toe responses were associated with sacral neuromodulation lead revision. These data suggest that placing a lead with more toe responses during testing may result in more durable sacral neuromodulation therapy.

The history of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction.

AIMS: To review the history of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). METHODS: We reviewed Society meeting minutes, contacted all living former Society presidents, searched the William P. Didusch Center for Urology History records, and asked Society members to share their important Society experiences in order to gather important historical information about the Society. RESULTS: The Society initially formed as the Urodynamics Society in 1969 in the backdrop of a growing passion for scientific research in the country after World War II ended. Since then, Society meetings have provided a pivotal forum for the advancement of science in lower urinary tract dysfunction. Meetings occurred annually until 2004, when the meeting schedule increased to biannual. The journal, Neurourology and Urodynamics, became the official journal of the Society in 2005. SUFU has authored important guidelines on urodynamics (2012), non-neurogenic overactive bladder (2012), and stress urinary incontinence (2017) and has shared important collaborations with other societies, including the American Urological Association (AUA), the International Continence Society (ICS), and the International Society of Pelvic Neuromodulation (ISPiN). SUFU has also been instrumental in trainee education and helped to establish formal fellowship training in the field in addition to holding a yearly educational meeting for urology residents. The Society has been led by 21 presidents throughout its history. CONCLUSION: Throughout the Society's near half-century long existence, the Society has fostered research, published guidelines, and educated trainees in order to improve the care of individuals suffering from lower urinary tract dysfunction.

Real-Time Changes in Brain Activity during Sacral Neuromodulation for Overactive Bladder.

PURPOSE: We performed functional magnetic resonance imaging to identify changes in brain activity during sacral neuromodulation in women with overactive bladder who were responsive to therapy. MATERIALS AND METHODS: Women recruited into the study had nonneurogenic refractory overactive bladder, responded to sacral neuromodulation and had had a stable program for at least 3 months with no subsequent overactive bladder treatment. Enrolled patients completed validated symptom and quality of life instruments before functional magnetic resonance imaging. Stimulus settings were recorded, devices were switched off for a 5-day washout and instruments were repeated. Three functional magnetic resonance imaging scans with simultaneous sacral neuromodulation stimulation were performed below, at and above stimulus sensory threshold using a block design. This yielded brain activity maps represented by changes in blood oxygenation level dependence. A total of 5 stimulator off and 4 stimulator on cycles of 42 seconds each were imaged. Group analysis was done using a single voxel p value of 0.05 with a false-positive error of 0.05 on cluster analysis. RESULTS: Six of the 13 patients enrolled completed functional magnetic resonance imaging. Median age was 52 years (range 36 to 64). Urinary symptoms and voiding diary data worsened with washout. Overall brain activation generally progressed with increasing stimulation amplitude. However, activation of the right inferior frontal gyrus remained stable while deactivation of the pons and the periacqueductal gray matter only occurred with subsensory stimulation. Sensory stimulation activated the insula but deactivated the medial and superior parietal lobes. Suprasensory stimulation activated multiple structures and the expected S3 somatosensory region. All devices had normal impedance after functional magnetic resonance imaging. CONCLUSIONS: Functional magnetic resonance imaging confirmed that sacral neuromodulation influences brain activity in women with overactive bladder who responded to therapy. These changes varied with stimulus intensity.

Impact of Age and Comorbidities on Use of Sacral Neuromodulation.

PURPOSE: We investigated the influence of patient age on sacral nerve stimulation trial outcomes, device implantation and treatment durability. MATERIALS AND METHODS: We analyzed a database of all sacral nerve stimulation procedures performed between 2012 and 2014 at a high volume institution for associations of patient age with sacral nerve stimulation indication, trial stimulation success, device revision and device explantation. RESULTS: In a cohort of 356 patients those with nonobstructive urinary retention and urgency-frequency were younger than patients with urgency urinary incontinence. Trial stimulation success did not differ by age in stage 1 and percutaneous nerve evaluation trials (p = 0.51 and 0.84, respectively). Logistic regression identified greater odds of trial success in females compared to males (OR 2.97, 95% CI 1.32-6.04, p = 0.009) and for urgency urinary incontinence compared to urgency-frequency (OR 3.02, 95% CI 1.39-6.50, p = 0.006). In analyzed patients there were 119 surgical revisions, including battery replacement, and 53 explantations. Age was associated with a decreased risk of revision with 3% lower odds per each additional year of age (OR 0.97, 95% CI 0.95-0.98, p <0.0001). While age did not influence explantation, for each body mass index unit there was a 5% decrease in the odds of explantation (OR 0.95, 95% CI 0.91-0.98). CONCLUSIONS: In contrast to previous studies, older patients experienced no difference in the sacral nerve stimulation response in stimulation trials and no difference in the implantation rate. Furthermore, age was modestly protective against device revision. This suggests that age alone should not negatively predict sacral nerve stimulation responses.

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.

Treatment of vaginal stenosis with fasciocutaneous Singapore flap.

INTRODUCTION: Vaginal stenosis is an unfortunate complication that can occur after pelvic radiation therapy for gynecologic or colorectal malignancies. Treatment is challenging and can require significant reconstructive surgery. The objective of this video is to present a case of vaginal stenosis after radiation and describe vaginal reconstruction with a fasciocutaneous Singapore flap. METHODS: We describe the case of a 42-year-old woman with a history of stage 3 colorectal cancer who underwent partial colectomy, chemotherapy, and pelvic radiation. She subsequently developed a rectovaginal fistula requiring repair with a right-sided gracilis flap. When her stenosis recurred, she underwent vaginal reconstruction with a medial thigh flap. RESULTS: The Singapore flap is a pudendal thigh flap centered on the labial crural fold with a base at the perineal body. As the cutaneous innervation is spared, this flap is sensate. This technique is one option for patients with complex vaginal stenosis who have failed conservative management. However, it is imperative the patient perform vaginal dilation postoperatively and maintain close follow-up with her surgeon, as vaginal stenosis can recur. CONCLUSIONS: Postradiation vaginal stenosis is a complex condition to treat; however, vaginal reconstruction with a thigh flap can provide excellent cosmetic and functional results.

Sacral Neuromodulation Implant Infection: Risk Factors and Prevention.

Device infection is one of the most common complications of sacral nerve stimulator placement and occurs in approximately 3-10% of cases. Infection is a serious complication, as it often requires complete explantation of the device. Not much is known regarding risk factors for and methods of preventing infection in sacral nerve stimulation. Multiple risk factors have been linked to device infection including prolonged percutaneous testing and choice of preoperative antibiotic. Methods of infection prevention have also been studied recently, including antibiotic-impregnated collage and type of skin preparation. This review will discuss the recent literature identifying risk factors and means of preventing infection in sacral nerve stimulation. Finally, we will outline a protocol we have enacted at our institution which has resulted in an incidence of infection of 1.6%.

Transvaginal neobladder vaginal fistula repair after radical cystectomy with orthotopic urinary diversion in women.

AIM: We present the surgical management and outcomes of patients who underwent transvaginal neo-bladder vaginal fistula (NBVF) repair at our institution. METHODS: Between 2002 and 2012, eight patients underwent transvaginal NBVF repair. The surgical management entailed placing a Foley catheter into the fistula tract. A circumferential incision was made around the fistula tract after which a plane between the serosa of the neobladder and the vaginal epithelium was created. Interrupted polyglycolic acid sutures were used to close the fistula. An additional layer of vaginal wall, Martius, or omental flap was interposed before vaginal wall closure. A urethral catheter was placed for a minimum of 14 days and removed after a negative cystogram and pelvic exam with retrograde neobladder filling without leakage. RESULTS: All patients presented with a fistula following radical cystectomy with orthotopic ileal neobladder. Two patients had failed two prior transvaginal fistula repairs. A unilateral Martius flap was used in five patients and an omental flap was used in one patient. The surgery was successful in all patients. After a mean follow up of 33 months [4-117], five patients underwent or are waiting to undergo management of stress urinary incontinence with bulking agents. No patient had a recurrent fistula. CONCLUSIONS: Management of NBVF is challenging but cure is possible using a transvaginal approach. Most patients will suffer from incontinence after the repair because of a short and incompetent urethra. Patients should be counseled about the high probability of requiring a secondary procedure to achieve continence.