How to define failure of intradetrusor injections of botulinum toxin A for neurogenic detrusor overactivity.

INTRODUCTION: Neurogenic detrusor overactivity (NDO) has a major impact on patients' quality of life and can lead to upper urinary tract complications. Intradetrusor botulinum toxin type A injections are administered as second-line treatment to these patients following the failure of anticholinergic agents. The aim of the DETOX 2 study is to propose a consensus definition of the failure of intradetrusor botulinum toxin injections for NDO in patients presenting spinal cord injury, spina bifida, or multiple sclerosis (MS) with self-catheterization. METHOD: This study followed the method adopted by the French National Authority for Health for recommendations by consensus. Based on a review of the literature and a preliminary survey, a steering committee compiled a questionnaire and selected a rating group comprising 16 experts from the Neuro-Urology Committee of the French Urology Association (cnuAFU) and Genulf. The experts were asked to complete the online questionnaire. At the end of the first round, all participants came together to discuss any disagreements and a second-round online questionnaire was completed to reach a consensus. RESULTS: Thirteen of the 16 experts approached completed both rounds of questionnaires. A strong consensus was reached for two proposals (median score = 9/10) which were therefore included in the definition from the first round: at least one repeat injection of the same botulinum toxin at the same dose must be given to rule out failure on technical grounds and a duration of efficacy <3 months must be considered a failure. At the end of round 2, a relative consensus was reached regarding the clinical criterion defining failure (median score = 7/10) and the urodynamic criterion of failure (median score = 8/10). An additional proposal was selected during this second round on the need for a voiding diary (median score = 8/10). CONCLUSION: The first consensus definition of failure of an intradetrusor injection of TB-A for NDO has been achieved with this study: persistence of detrusor overactivity with maximum detrusor pressures >40 cm H2O and/or a compliance issue and/or persistence of urinary incontinence and/or urgency and/or a number of daily self-catheterizations >8/day and/or efficacy <3 months. This study will help to standardize research on the failure of the intradetrusor botulinum toxin for NDO in clinical practice and clinical research.

Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

Management of female pelvic organ prolapse-Summary of the 2021 HAS guidelines.

When a patient presents with symptoms suggestive of pelvic organ prolapse (POP), clinical evaluation should include an assessment of symptoms, their impact on daily life and rule out other pelvic pathologies. The prolapse should be described compartment by compartment, indicating the extent of the externalization for each. The diagnosis of POP is clinical. Additional exams may be requested to explore the symptoms associated or not explained by the observed prolapse. Pelvic floor muscle training and pessaries are non-surgical conservative treatment options recommended as first-line therapy for pelvic organ prolapse. They can be offered in combination and be associated with the management of modifiable risk factors for prolapse. If the conservative therapeutic options do not meet the patient's expectations, surgery should be proposed if the symptoms are disabling, related to pelvic organ prolapse, detected on clinical examination and significant (stage 2 or more of the POP-Q classification). Surgical routes for POP repair can be abdominal with mesh placement, or vaginal with autologous tissue. Laparoscopic sacrocolpopexy is recommended for cases of apical and anterior prolapse. Autologous vaginal surgery (including colpocleisis) is a recommended option for elderly and fragile patients. For cases of isolated rectocele, the posterior vaginal route with autologous tissue should be preferentially performed over the transanal route. The decision to place a mesh must be made in consultation with a multidisciplinary team. After the surgery, the patient should be reassessed by the surgeon, even in the absence of symptoms or complications, and in the long term by a primary care or specialist doctor.

Robot-assisted laparoscopic cystectomy with non-continent urinary diversion for neurogenic lower urinary tract dysfunction: Midterm outcomes.

OBJECTIVES: The aim of this study was to assess midterm functional outcomes and complications of robot-assisted laparoscopic cystectomy with non-continent urinary diversion in patients with neurogenic lower urinary tract dysfunction. MATERIALS AND METHODS: We performed a retrospective single center study including all patients who underwent robot-assisted laparoscopic cystectomy with non-continent urinary diversion between January 2008 and December 2018 for neurogenic lower urinary tract dysfunction. Perioperative data, early and late complications, reoperation rate, renal function, and patient satisfaction (PGI-I) were evaluated. RESULTS: One hundred and forty patients were included (70 multiple sclerosis, 37 spinal cord injuries, 33 others) with a median follow-up of 29 months (12-49). The main indication for surgery was an inability to perform intermittent self-catheterization (n = 125, 89%). The early complication rate (<30 days) was 41% (n = 58), including 72% (n = 45) minor complications (Clavien I-II) and 29% (n = 17) major complications (Clavien III-V). Three patients died in the early postoperative period. Late complications appear in 41% (n = 57), with 9% (n = 13) being ureteroileal anastomotic stricture. The overall reintervention rate was 19% (n = 27), mainly for lithiasis surgery. Pre- and postoperative renal function were comparable. Most of patients reported an improvement in their quality of life following their surgery (PGI-I 1-2). CONCLUSION: Robot-assisted laparoscopic cystectomy with non-continent urinary diversion may be of particular interest in patients with neurogenic lower urinary tract dysfunction who are unable to benefit from conservative treatment, as it provides midterm protection of the upper urinary tract and an improvement in quality of life.

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications.

OBJECTIVE: The objective of this study was to assess the mid-term efficacy and safety of adjustable continence therapy (ProACT™) for the treatment of male stress urinary incontinence (SUI) after radical prostatectomy (RP). PATIENTS AND METHODS: Single-center retrospective study including male patients implanted with ProACT™ periurethral balloons for SUI after RP between 2007 and 2017, mainly with flexible cystoscopic guidance. Efficacy was assessed using a composite endpoint with subjective (patient's impression of improvement (PII), using a 0-100 numeral rating scale) and objective outcomes (decrease in daily pad use). Postoperative success was defined as a PII ≥ 80%, associated with the use of 0-1 pad daily. Improvement was defined as a PII ≥ 50% and a decrease ≥50% in the number of daily pads used. RESULTS: Two hundred men with a median age of 68 (64-73) years were included. Seventeen percent (n = 34) had had prior radiotherapy and 15.5% (n = 31) had had prior SUI surgery. The median follow-up was 43 (19-71) months. The severity of SUI was as follows: mild in 119 (59.5%), moderate in 48 (24%), and severe in 33 patients (16.5%). Severe SUI and a history of prior radiotherapy were associated with a lower success rate (p = 0.033 and p < 0.0001). The overall reoperation rate was 34%, with 5.6% (n = 11) requiring a third implantation. Of the patients, 29.4% (n = 58) required an artificial urinary sphincter to treat SUI. At the last follow up, among the overall population, the success rate was 40.1% and the median PII was 18.3%. For patients in whom the balloons were still in place (n = 132), the cumulative success and improvement rate was 78%, with a median PII of 72%. CONCLUSION: The minimally invasive ProACT™ device provides a clear beneficial continence outcome in patients with SUI after radical prostatectomy. Severe SUI or prior radiotherapy were associated with a lower success rate in our study.

Management of post-operative urinary incontinence after midurethral sling explantation for pelvic or perineal pain.

INTRODUCTION AND HYPOTHESIS: The objective was to report the management of post-operative urinary incontinence after midurethral sling (MUS) revision for chronic pelvic pain (CPP), and to report functional outcomes. METHODS: From November 2004 to February 2018, a total of 89 women who underwent removal or section of MUS for CPP, were enrolled. Patients were divided into the transobturator tape (TOT) group (50 patients) and the tension-free vaginal tape (TVT) group (37 patients); 2 patients had had both slings implanted. We report the rate of stress urinary incontinence (SUI) recurrence, the rate of de novo urge urinary incontinence (UUI), the need for subsequent SUI or UUI surgery, and functional outcomes (pain and continence). RESULTS: Median follow-up was 41.4 months [0.9-138.8]. SUI recurrence or de novo UUI occurred in 52 cases (58.4%): 19 (51.3%) patients in the TVT group, 31 (62%) in the TOT group, and both patients (100%) who underwent total removal of both slings. Among patients with SUI recurrence or de novo UUI, 39 (75%) had pain relief after sling removal. Seventeen patients (32.6%) refused any treatment, 14 (26.9%) were cured with conservative therapy, and 21 (40.3%) underwent SUI or UUI surgery. One patient had de novo pelvic pain after reoperation. The overall continence rate for all patients who underwent sling revision was 82% (73 out of 89) at the last follow-up. CONCLUSION: After MUS revision for CPP, post-operative UI may occur in 58.4% of patients, of which, one-fourth may be managed with conservative measures only. Forty percent of them had redo surgery with a low risk of pain recurrence and a high rate of urinary continence.

Outcomes of pregnancy and delivery in women with continent lower urinary tract reconstruction: systematic review of the literature.

INTRODUCTION AND HYPOTHESIS: The aim of this systematic review of the literature was to pool all the existing data regarding pregnancy and delivery in women with neurogenic bladder or bladder exstrophy who had undergone previous lower urinary tract reconstruction (LUTR). METHODS: We conducted a systematic review of the literature from PubMed/MedLine, ClinicalTrials.gov and the Google Scholar database, from 1972 to July 2020. Fifty articles were included, of which 25 contained data that could be pooled (229 women representing 292 pregnancies). RESULTS: Ninety-eight women had bladder exstrophy (43%), 58 had spinal dysraphism (25%), 14 had spinal cord injury (6%), and 59 presented other pathological conditions. Of these, 138 have had an augmentation cystoplasty (61%), 42 (18%) had a continent cutaneous urinary diversion, and 31 had an artificial urinary sphincter (14%). During their pregnancy, 97 women (33%) experienced at least one febrile urinary tract infection. Thirty-one women (11%) required ureteral stenting or nephrostomy placement for upper urinary tract dilatation. Forty-six pregnancies ended with premature delivery (16%). Delivery mode was by C-section for 108 patients (62%) and vaginal delivery for 104 (36%). Twenty complications were reported during delivery (mainly urological), of which 19 occurred during C-section. Nine women experienced postpartum urinary incontinence (4%); in 5 of then this was due to urinary fistulae secondary to complicated C-section. CONCLUSIONS: Pregnancy and vaginal delivery are possible for women with LUTR who have no obstetric or medical contraindications, except for some particular cases of bladder exstrophy. However, these high-risk pregnancies and deliveries should be managed by a specialist multidisciplinary team.

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study.

BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Effectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Voids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. CONCLUSIONS: Through a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. PATIENT SUMMARY: These analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02186041.

Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial.

AIM: To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing. METHODS: A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed. RESULTS: Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239). CONCLUSION: Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.

Valsalva urethral profile (VUP): A urodynamic measure to assess stress urinary incontinence in women.

AIMS: We aimed to assess the value of the Valsalva urethral profile (VUP) in case of stress urinary incontinence (SUI). METHODS: Six hundred and ninety-four women without pelvic organ prolapse were included in this prospective monocentric study. SUI was diagnosed from symptoms using the International Continence Society definition, and severity using two validated questionnaires (USP and ICIQ-SF). The urodynamic parameters studied were maximal urethral closure pressure (MUCP) and functional length (FL). Both were performed at rest, during a Valsalva maneuver (v-MUCP and v-FL) and again at rest. Correlation analyses and ROC curves were used to assess the value of the clinical and urodynamic measurements. RESULTS: In our population, based on the questionnaires, 172 (24.8%) women were diagnosed with pure SUI on symptoms, 71 (10.2%) with urgency urinary incontinence and 392 (56.5%) with mixed urinary incontinence; 59 (8.5%) women were continent. The v-MUCP was the most correlated parameter to the severity of SUI (ρ: -0.63) and the most predictive of SUI risk, with a threshold value of 35 cm H2 O (Se = 0.82, Sp = 0.86). The v-FL was significantly shortened in case of SUI. CONCLUSIONS: The v-MUCP and v-FL are global measurements of urethral resistance during stress. With a threshold value of 35 cm H2 O, the v-MUCP was the most discriminating parameter for the diagnosis of SUI, with a good reliability.

Efficacy and tolerance of botulinum toxin injections after sacral nerve stimulation failure for idiopathic overactive bladder.

INTRODUCTION: Management of idiopathic overactive bladder (iOAB) after the failure of sacral nerve modulation (SNM) is very challenging. To the best of our knowledge, no study has evaluated the use of botulinum toxin A (BoNT-A) after SNM failure for iOAB. The aim of this study is to evaluate the tolerance and efficacy of BoNT-A injection after the failure of SNM for iOAB. METHODS: We conducted a retrospective multicentric analysis of all patients who had received either onabotulinumtoxinA or abobotulinumtoxinA intradetrusor injection for iOAB after SNM failure, between January 2004 and December 2017. The primary outcome was the percentage of success of first BoNT-A injection (either resolution of their urinary incontinence or their frequency or more than 50% reduction in frequency). Secondary outcomes were results of urodynamic studies, complications, total number of injections, causes of withdrawal, and subsequent treatment. RESULTS: Seventy-six patients (62 female) were included. The percentage of success of first BoNT-A injection was 43.4% (n = 33). All overactive bladder symptoms were significantly improved on the 3-day bladder diary. Twenty-eight patients (36.8%) were put under clean intermittent self-catheterization transitory. After a mean follow-up of 57.7 (±38.5) months, median number of injections was 2 (1-15). Overall, 42 patients (55.2%) stopped injections during follow-up. The estimated 36-months discontinuation-free rate was 48.1%. Mean cause of discontinuation was a primary failure (n = 32; 42.1%). CONCLUSION: BoNT-A can be used in SNM nonresponders with a success rate of 43.4% but is associated with a high long-term discontinuation rate.

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Neurogenic stress urinary incontinence: is there a place for Adjustable Continence Therapy (ACT™ and ProACT™, Uromedica, Plymouth, MN, USA)? A retrospective multicenter study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To assess the effectiveness and complications of treatment for neurogenic stress urinary incontinence (nSUI) by Adjustable Continence Therapy (ACT™ and ProACT™). SETTING: France. METHODS: A retrospective multicentre study of consecutive patients with neurological pathologies treated for nSUI with ACT balloons. RESULTS: From January 2001 to January 2013, 102 patients were implanted. Mean (SD) age at implantation was 48.4 (16.5) years. Patients were followed-up for a mean 2.7 (2.3) years. After implantation, 5.9% of patients were totally continent, 51.2% had an improvement in symptoms of at least 50% (including 14.6% with improvements of at least 90%), and 48.8% had improvements of < 50%, including 7.3% of treatment failures. Complications occurred in 70 patients (120 balloons): 21 balloon infections, 34 migrations, 18 device failures, 28 urethral erosions and 28 cutaneous erosions. The procedure was ineffective for 35 patients. Twenty patients underwent permanent explantation. The rate of migrations was lower in patients with upper motor neuron lesion than in those with lower motor neuron lesion (p = 0.04). CONCLUSIONS: ACT is a minimally invasive treatment for SUI related to sphincter deficiency. This is one of the first reports in a sample of patients with neurological disorders implanted by multiple surgeons. ACT could be a less invasive, appropriate alternative to artificial urinary sphincters. However, it is associated with frequent local complications which are easy to manage but that should be reduced in this challenging population.

Stratification of Patients With Interstitial Cystitis/Bladder Pain Syndrome According to the Anatomical Bladder Capacity.

OBJECTIVE: To compare the data of score symptoms (Interstitial Cystitis Problem Index, Interstitial Cystitis Symptom Index, Pelvic Pain and Urgency/Frequency Patient Symptom Scale and SF-36quality of life), voiding diaries, urodynamic studies, and cystoscopy under general anesthesia according to the anatomical bladder capacity for patients with interstitial cystitis/bladder pain syndrome (IC/BPS). MATERIAL AND METHOD: Single-centre descriptive observational epidemiological study based on retrospective review of 134 patients managed for IC/BPS between January 2010 and December 2016. Patients were stratified into 2 groups according to anatomical bladder capacity measured under general anesthesia: ≤400 mL (n = 40) and >400 mL (n = 94). RESULTS: Patients with an anatomical bladder capacity less than 400 of mL presented significantly different results for voiding diary data: higher total frequency (P = .0023) especially at night (P = .0008), lower functional bladder capacity (P = .0082) and lower maximum bladder capacity (P = .0001); urodynamic data: earlier onset of painful urge during bladder filling (P = .0002), lower maximum bladder filling capacity (P = .0001) and lower compliance (P = .0067); and the findings of cystoscopy under general anesthesia: more Hunner's lesions (P = .00013). These patients presented poorer Pelvic Pain and Urgency/Frequency Patient Symptom Scale symptom scores (P = .0176) but associated with better overall quality of life as assessed by SF-36 (P = .0295). CONCLUSION: The anatomical bladder capacity, measured under general anesthesia, can be used objectively to define 2 distinct groups of patients with symptoms of IC/BPS.

Artificial Urinary Sphincter in Male Patients with Spina Bifida: Comparison of Perioperative and Functional Outcomes between Bulbar Urethra and Bladder Neck Cuff Placement.

PURPOSE: We evaluated the perioperative and long-term functional outcomes of bladder neck and peribulbar cuff placement of an artificial urinary sphincter in a population of adult male patients with spinal dysraphism. MATERIALS AND METHODS: We retrospectively analyzed the French spina bifida network database. Patients who underwent implantation of an artificial urinary sphincter from January 1985 to November 2015 were selected and stratified into 2 groups according to cuff location, that is bladder neck vs bulbar urethra. Explantation-free and revision-free device survival was estimated by the Kaplan-Meier method and compared with the log rank test. Cox regression models were created to assess prognostic factors of artificial urinary sphincter device failure. RESULTS: A total of 65 patients were included in study. Most patients were not wheelchair bound. The cuff was implanted around the bulbar urethra at 46 procedures (59%) and around the bladder neck in 32 (41%). In the peribulbar and bladder neck groups median revision-free device survival was 11.7 and 14.3 years, respectively (p = 0.73). Median explantation-free device survival was 18.5 and 24.5 years, respectively (p = 0.08). On multivariate analysis clean intermittent catheterization was the only predictor of artificial urinary sphincter device failure. Cuff location had no influence. At the last followup satisfactory continence was similar in the 2 groups (83% vs 75%, p = 0.75). CONCLUSIONS: In male patients with spinal dysraphism morbidity and functional outcomes were similar for bladder neck and bulbar urethra cuff placement but with a trend toward longer survival without explantation in the bladder neck group. Clean intermittent catheterization was the only predictor of shorter device survival on multivariate analysis.

Feasibility, Morbidity, and Functional Results of Supratrigonal Cystectomy with Augmentation Ileocystoplasty by Combined Robot-Assisted Laparoscopy and Mini-Laparotomy Approach.

OBJECTIVES: Evaluation of the feasibility, morbidity, learning curve, and functional results of robotic supratrigonal cystectomy with augmentation ileocystoplasty (RSCAI). MATERIALS AND METHODS: RSCAI was performed in 19 patients between 2012 and 2016. Thirteen patients (66.4%) presented refractory detrusor overactivity or impaired compliance and 6 patients (31.6%) had painful bladder syndrome. A combined robot-assisted laparoscopy and mini-laparotomy approach was performed. Early (<30 days) and late (>30 days) complications were reported according to the Clavien-Dindo classification. Functional results were analyzed according to the surgical indication. RESULTS: Mean total operating time was 288.7 ± 92.1 minutes. Mean intraoperative blood loss was 147.4 ± 144.8 mL. Mean length of hospital stay in the surgical ward was 9.4 ± 3.7 days. Mean duration of bladder drainage was 23.3 ± 4.1 days. For surgeons who regularly performed robot-assisted laparoscopy, the learning curve of this technique, as assessed by the operating time, required almost five operations. No major (Clavien-Dindo >2) early (0%) or late (0%) postoperative complication was observed. Early minor complications were observed in 47.4% of cases, usually consisting of pyelonephritis (21.1%). Late minor complications (10.5%) were Clavien-Dindo grade I. Mean follow-up was 13.6 ± 10.1 months. The majority of patients (94.7%) obtained functional improvement of their disease in terms of pain, functional bladder capacity, or bladder compliance. CONCLUSION: Our RSCAI technique is a reliable technique with no early or late major postoperative complications reported in this series. This technique allows patients to be operated by minimally invasive surgery with very satisfactory long-term functional results.

Comparison of the morbidity and mortality of cystectomy and ileal conduit urinary diversion for neurogenic lower urinary tract dysfunction according to the approach: Laparotomy, laparoscopy or robotic.

OBJECTIVES: To evaluate and compare the morbidity and mortality of cystectomy-ileal conduit urinary diversion in patients with neurogenic lower urinary tract dysfunction according to the surgical approach, and to evaluate predictive factors of early and late morbidity. METHODS: This was a single-center retrospective study based on 65 patients operated between May 2005 and December 2011. The surgical approach consisted of: laparotomy (n = 11), laparoscopy (n = 14) and robotic (n = 40). Evaluation of early (<30 days) and late (>30 days) morbidity and mortality was carried out according to the Clavien-Dindo classification. RESULTS: The operating time was longer (P = 0.007) and the mean time to return of bowel function was shorter (P = 0.012) in the robotic group. The early complication rate for the overall population was 41.5%: minor complications in 32.3% of cases and major complications in 9.2% of cases. A tendency towards a lower minor complication rate was observed in favor of robotic surgery (P = 0.08), with a reduction of the postoperative hemorrhagic complication rate (P = 0.03). The late complication rate for the overall population was 43.1%: minor complications in 20% and major complications in 23.1%. A lower surgical revision rate under general anesthesia was observed in favor of robotic surgery (P = 0.03). No predictive factor of early and late morbidity was identified. CONCLUSION: Robotic cystectomy-ileal conduit urinary diversion in patients with neurogenic lower urinary tract dysfunction is feasible and safe. Its morbidity in experienced hands seems to be limited and comparable with laparoscopy or open surgery.

Validation of voiding diary for stratification of bladder pain syndrome according to the presence/absence of cystoscopic abnormalities: a two-centre prospective study.

OBJECTIVE: To assess the value of the voiding diary in the management of patients with bladder pain syndrome for predicting the presence or absence of cystoscopic abnormalities. PATIENTS AND METHODS: From November 2009 to March 2011, 54 consecutive patients (39 women and 15 men) with bladder pain syndrome, as defined by the European Society for the Study of Interstitial Cystitis/Bladder Pain Syndrome (ESSIC) criteria, were prospectively enrolled in this two-centre study. All patients completed a home voiding diary on 3 consecutive days, which included analysis of voiding frequency, voided volume and severity of pre- and post-voiding pain. The variables were evaluated on a numeric pain scale (NPS). All patients then underwent standardized cystoscopy under anaesthesia. Patients were stratified into two groups: a group with or a group without cystoscopic abnormalities. Voiding diary variables were compared using Student's t-test. RESULTS: Cystoscopic abnormalities were found in 33 patients. The group of patients with cystoscopic abnormalities had significantly more severe frequency (P = 0.034), especially nocturnal frequency (P = 0.009), a significantly lower mean voiding volume and lower sd from the mean (P = 0.011 and P = 0.014), and a significantly lower mean post-voiding NPS score (P = 0.039). CONCLUSION: On analysis of the voiding diaries, we found that different patient profiles were associated with the cystoscopic appearance of the bladder. A clinical voiding score was proposed to predict the cystoscopic appearance of the bladder on the basis of the voiding diary in bladder pain syndrome but needs to be validated on an independent population.

Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study.

BACKGROUND: In the treatment of patients with idiopathic overactive bladder (iOAB), high doses of botulinum toxin type A (BoNTA) were often associated with complications resulting from high postvoid residuals (PVR), leading to clean intermittent catheterisation (CIC) and urinary tract infections (UTI). OBJECTIVE: Evaluate the efficacy and tolerability of low doses of onabotulinumtoxinA compared to placebo in patients with iOAB. DESIGN, SETTING, AND PARTICIPANTS: Between 2005 and 2009, adults with persistent iOAB were included in a prospective, randomised, double-blind, placebo-controlled comparative trial. INTERVENTION: Patients were randomised to undergo a single intradetrusor injection procedure of either placebo or onabotulinumtoxinA (50 U, 100 U or 150 U). MEASUREMENTS: The initial evaluations (ie, clinical and urodynamic variables as well as quality of life [QoL]) were repeated at day 8 and months 1, 3, 5, and 6. RESULTS AND LIMITATIONS: Ninety-nine patients were included in the efficacy analysis. Three months after the procedure, we observed>50% improvement versus baseline in urgency and urge urinary incontinence (UUI) in 65% and 56% of patients who respectively received 100 U (p=0.086) and 150 U (p=0.261) BoNTA injections and >75% improvement in 40% of patients of both groups (100 U [p=0.058] and 150 U [p=0.022]). Complete continence was observed in 55% and 50% patients after 100 U and 150 U BoNTA treatment, respectively, at month 3. Frequency symptoms and QoL improved up to the 6-mo visit. We observed only three patients with a PVR>200 ml in the 150 U group and a few UTIs. CONCLUSIONS: 100 U and 150 U BoNTA injections were well tolerated and have both shown to improve symptoms and QoL in patients with iOAB. Nevertheless, 100 U injections showed a reasonable efficacy, with a lower risk of high PVR. TRIAL REGISTRATION: ClinicalTrials.gov NCT00231491.