Overactive bladder negatively affects erectile function and promotes premature ejaculation: findings from large representative population-level study.

PURPOSE: The effect of overactive bladder (OAB) on sexual health has been evaluated extensively for women but much less for men. Therefore, the aim of this study was to evaluate the relationship between OAB and men's sexual activity and the effect of OAB on erectile dysfunction (ED) and premature ejaculation (PE) in a large representative cohort of men at the population level. METHODS: This study was based on computer-assisted web interviews that used validated questionnaires. The most recent census and the sample size estimation calculations were employed to produce a population-representative pool. RESULTS: The study included 3001 men, representative of the population in terms of age and place of residence. The frequency of sexual intercourse was higher for respondents without OAB symptoms compared with persons who had OAB (p = 0.001), but there was no association between OAB symptoms and number of sexual partners (p = 0.754). Regression models did not confirm the effect of OAB on sexual activity (odds ratio 0.993, CI 0.974-1.013, p = 0.511). Both ED and PE were more prevalent in respondents with OAB symptoms compared with persons who lacked those symptoms (p < 0.001). Importantly, the effect of OAB on ED or PE was independent of age, comorbidities, and lifestyle habits (regression coefficients of 0.13 and 0.158 for ED and PE, respectively). CONCLUSION: Overactive bladder did not significantly affect men's sexual activity, but it significantly correlated with ED and PE. Our results suggest a need in daily clinical practice to screen for OAB symptoms for persons who report ED or PE.

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.

Outcomes of sequential third-line therapies in patients with refractory overactive bladder.

INTRODUCTION: Sacral neuromodulation (SNM) and onabotulinumtoxinA (BoNTA) injection are third-line therapies for overactive bladder (OAB). Although the efficacy of each third-line treatment has been well established in clinical trials, there is far less information about performing one third-line therapy after the other. Our aim is thus to investigate the outcomes of post-SNM BoNTA and post-BoNTA SNM as "second" third-line treatments. METHODS: We retrospectively reviewed all OAB patients who had both SNM and BoNTA between 2013 and 2022. The primary endpoint was the response rates (>50% improvements) of the second third-line treatments. Secondary endpoints were the proportion of the patients who achieved total dry, the duration of treatments of patients who had significant responses, and risk factors that are associated with treatment response or duration of treatments. RESULTS: A total of 172 patients had two third-line therapies. There were 104 patients who had post-SNM BoNTA and 68 patients who had post-BoNTA SNM. In the post-SNM BoNTA group, 62.5% (65/104) had significant responses after BoNTA treatment. In the post-BoNTA SNM group, 61.8% (44/68) had significant responses after SNM treatment. The proportions of patients who became dry were 21.2% and 23.5%, respectively. In the post-SNM BoNTA group, spinal pathology is associated with a lower probability of a significant response (48.9% vs. 73.7%, p-value = 0.0105). CONCLUSIONS: BoNTA or SNM remains a viable option for refractory OAB after patients fail from one another. Spinal pathology is associated with a poorer response of post-SNM BoNTA.

First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor.

PURPOSE: Urodynamics is the standard method of diagnosing bladder dysfunction, but involves catheters and retrograde bladder filling. With these artificial conditions, urodynamics cannot always reproduce patient complaints. We have developed a wireless, catheter-free intravesical pressure sensor, the UroMonitor, which enables catheter-free telemetric ambulatory bladder monitoring. The purpose of this study was twofold: to evaluate accuracy of UroMonitor pressure data, and assess safety and feasibility of use in humans. MATERIALS AND METHODS: Eleven adult female patients undergoing urodynamics for overactive bladder symptoms were enrolled. After baseline urodynamics, the UroMonitor was transurethrally inserted into the bladder and position was confirmed cystoscopically. A second urodynamics was then performed with the UroMonitor simultaneously transmitting bladder pressure. Following removal of urodynamics catheters, the UroMonitor transmitted bladder pressure during ambulation and voiding in private. Visual analogue pain scales (0-5) were used to assess patient discomfort. RESULTS: The UroMonitor did not significantly alter capacity, sensation, or flow during urodynamics. The UroMonitor was also easily inserted and removed in all subjects. The UroMonitor reproduced bladder pressure, capturing 98% (85/87) of voiding and nonvoiding urodynamic events. All subjects voided with only the UroMonitor in place with low post-void residual volume. Median ambulatory pain score with the UroMonitor was rated 0 (0-2). There were no post-procedural infections or changes to voiding behavior. CONCLUSIONS: The UroMonitor is the first device to enable catheter-free telemetric ambulatory bladder pressure monitoring in humans. The UroMonitor appears safe and well tolerated, does not impede lower urinary tract function, and can reliably identify bladder events compared to urodynamics.

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.

Effect of pulse width variations on sacral neuromodulation for overactive bladder symptoms: A prospective randomized crossover feasibility study.

INTRODUCTION/BACKGROUND: The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence-based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single-blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment. METHODS/MATERIALS: Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis. RESULTS: Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting "much better" or "very much better" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting "much better" or "very much better" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications. CONCLUSIONS: Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.

Patient perceived improvement and medication resumption rates after intradetrusor onabotulinumtoxina for idiopathic urgency urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Intradetrusor onabotulinumtoxinA (BTX-A) is a third-line therapy for overactive bladder (OAB), however several gaps exist in periprocedural care. Prior studies have demonstrated BTX-A efficacy at 2-3 weeks, but there are limited data documenting when patients should begin to note symptom improvement. The primary aim of this study was to evaluate patient-reported temporal improvement in symptoms, with secondary aim to evaluate medication resumption rates, following initial BTX-A injection. METHODS: A prospective, single-arm cohort study of patients with non-neurogenic urgency incontinence undergoing initial BTX-A injection was performed. Intradetrusor 100 units BTX-A was administered in standard 20-site template. Patients discontinued OAB medication(s) at BTX-A injection and completed a daily Patient Global Impression of Improvement (PGI-I) diary for 3 weeks. Data were collected at 1 month, including final satisfaction score, medication resumption rates, and adverse outcomes. RESULTS: Fifty-one patients were included, with 25 patients (49%) actively taking an OAB medication. Median time to first improvement was 3 days, at least "much better" (PGI-I <2) was 5 days, and maximal improvement was 7 days. Twenty of 25 patients (80%) opted to remain off OAB medications at 1 month based on symptomatic improvement following injection. Adverse outcomes included urinary tract infection in three patients (6%) and symptomatic incomplete emptying requiring temporary intermittent catheterization in two patients (4%). CONCLUSIONS: Median time to first and maximal improvement was 3 and 7 days, respectively, following initial 100 units BTX-A. Eighty percent of patients on medications opted to remain off at 1 month. These data may help further counsel patient expectations following initial BTX-A therapy.

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.

Is sacral neuromodulation effective in patients with Parkinson's disease? A retrospective review.

INTRODUCTION AND OBJECTIVE: Parkinson's disease (PD) is the second-most common degenerative neurologic disease worldwide. Overactive bladder (OAB) is prevalent in this population but can be challenging to treat. Sacral neuromodulation (SNM) is an attractive option but remains understudied. We have utilized SNM in PD patients and herein describe our outcomes. METHODS: We performed a retrospective chart review of PD patients who underwent peripheral nerve evaluation (PNE) or Stage 1 SNM from 2000 to 2020. The primary outcome was progression to a permanent implant. The impact of PD stage and preprocedural urodynamic (UDS) parameters on test-phase outcome were investigated. Long-term efficacy was assessed using Wilcoxon matched-pairs test looking at a change in urinary symptoms (frequency, nocturia, incontinence episodes, and pad use) documented at follow-up visits and further need for treatment. RESULTS: Thirty-four patients underwent test phase SNM (7 PNE and 27 Stage 1). Median follow-up was 11 (interquartile range 5.8-29.8) months. Indications included refractory OAB (30/34) and nonobstructive urinary retention (4/34). Overall, 82% (28/34) of patients proceeded to a permanent implant. 71% (5/7) of PNEs were successful. Test-phase success did not differ based on PD disease severity or UDS parameters. In patients with OAB/urgency incontinence who progressed to the permanent implant, there was a statistically significant improvement in their urinary symptoms from baseline. Most (68%) patients were able to discontinue OAB medications post-implant. The overall lead revision rate was 14% (4/28) and 3 devices required removal. CONCLUSIONS: SNM is an efficacious treatment option for PD patients with a high percentage of patients having improvement in their urinary symptoms.

SUFU white paper on overactive bladder anticholinergic medications and dementia risk.

AIMS: Anticholinergic medications are widely used in the treatment of overactive bladder (OAB), as well as for short-term treatment of bladder symptoms following a variety of urologic surgeries. Mounting evidence points to an association between anticholinergic medications and the increased risk of incident dementia. The Society for Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) thus convened a committee of subject experts to contextualize the current understanding of the cognitive risks of anticholinergic medications in the urologic patient population and to provide practical clinical guidance on this subject. METHODS: Statements are based on an expert literature review and the committee's opinion. The document has been reviewed and approved by the SUFU board. RESULTS: Chronic use (>3 months) of OAB anticholinergic medications is likely associated with an increased risk of new-onset dementia. Short-term (<4 weeks) use of most OAB anticholinergic medications is likely safe in most individuals. Clinicians should consider potential cognitive risks in all patient populations when prescribing OAB anticholinergics for chronic use. Consideration should be given to progressing to advanced therapy (botulinum toxin or neuromodulation) earlier in the OAB treatment paradigm CONCLUSIONS: The current body of literature supports a likely small but significant increased risk of dementia with chronic exposure to OAB anticholinergic medications. Potential harms should be balanced against potential quality of life improvement with treatment.

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.

Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial.

INTRODUCTION AND HYPOTHESIS: The objective was to assess whether telemedicine-based follow-up is equivalent to office-based follow-up in the early postoperative period after routine synthetic midurethral sling placement. METHODS: This is a prospective, international, multi-institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3-week postoperative telemedicine versus office-based follow-up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office-based follow-up, and compliance with 3- to 5-month office follow-up. RESULTS: We included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09-1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally "very satisfied" with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3- to 5-month office follow-up (90.1% vs 79.3%, p = 0.04). CONCLUSIONS: After synthetic midurethral sling placement, telemedicine follow-up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office-based follow-up but had greater compliance with 3- to 5-month follow-up.

Successfully treated urethral condyloma acuminatum utilizing intraurethral self-application of 5-fluorouracil via Q-tip.

Condyloma acuminatum is a benign genital lesion associated with low-risk human papillomavirus subtypes. Approximately 20% of HPV-associated genital warts occur in the urethra. Topical treatment of urethral condyloma in women can be challenging to treat due to difficulty applying the medication such that it maintains contact with the urethra long enough to be effective. We present a case of a successfully cleared urethral condyloma acuminatum treated via self-application using a Q-tip.

Same-day discharge across FPMRS surgical cases is safe and feasible: A 10-year single-surgeon experience.

INTRODUCTION: Enhanced recovery after surgery protocols and increased attention to value-based care have led to the reconsideration of routine postoperative admission in female pelvic medicine and reconstructive surgery (FPMRS) cases. We aimed to assess trends in same-day discharge (SDD) and associated readmissions and emergency room visits in a single-surgeon 10-year experience. METHODS: The electronic medical record was queried for 30-day outcomes (readmission and emergency department visits with associated indications) for all cases performed between June 2010 and August 2020 by a single FPMRS surgeon. Non-FPMRS specialty cases were excluded. Patient characteristics and 30-day outcomes were compared based on SDD status for the overall cohort as well as the subset of cases traditionally involving an overnight stay (i.e., robotic transabdominal, apical prolapse repair). RESULTS: 1793 surgeries were identified and analyzed, including 357 apical prolapse repairs, 370 slings, 392 neuromodulation and 114 complex mesh excisions. The majority (79.1%) had SDD. For admitted patients, mean length of stay was 1.5 (1.3) days. Among cases traditionally involving overnight stay, rates of SDD were significantly higher in 2020 than 2010 (84% vs. 32%, p < 0.001), and increased over time. Overall rates of 30-day readmission and ED visits were low (1.9% and 2.6%, respectively) and did not differ based on SDD status (p = 0.76). Readmissions occurred at mean 11.6 (7.0) days, most commonly for urinary tract infection (13/34). CONCLUSIONS: SDD is not associated with increased 30-day readmission or ED visits across a wide breadth of FPMRS cases. SDD is safe and feasible in the majority of FPMRS cases.

Predictive factors of PNE success in a contemporary series: A single institution experience.

PURPOSE: Peripheral nerve evaluation (PNE) permits a trial of sacral neuromodulation to determine candidates for single stage implant. Before routine fluoroscopy, PNE success rates were 40%-50% compared to approximately 77% with staged procedures. There are limited data on PNE success rates with the use of fluoroscopy and improved techniques. We evaluated a contemporary series of PNE patients to determine predictors of PNE success and persistent functional response following permanent implantation. METHODS: A retrospective review of PNE patients at a large academic center from 2015 to 2019 was performed. Patients with urgency-frequency, urge incontinence, and/or fecal incontinence (FI) were included. Rates of permanent implant after successful PNE trial and continued improvement at ≥1 month were reviewed. Multivariable logistic regression determined predictors of PNE success and continued response at follow-up. RESULTS: A total of 102 PNE patients were included. A total of 78 patients (76.5%) were PNE responders. Predictors of PNE success included younger age (p = .014), urgency incontinence (p = .021), FI (p = .017), absence of a neurologic diagnosis (p = .04), presence of bellows and toe responses (p = .038), and perineal sensation (p = .027). A total of 68 of 78 PNE responders (87.2%) maintained optimal responses at ≥1 month. Absence of a neurologic diagnosis was predictive of persistent success at follow-up (p = .013). CONCLUSIONS: This contemporary PNE series revealed screening success equivalent to a two-staged approach. A small proportion of patients demonstrate suboptimal responses following permanent implant. Conversion from testing to permanent implant may not be the ideal outcome as it may overestimate success, and evaluation for persistent improvement should be investigated further as a more reliable indicator of successful screening.

Deciphering the enigma of female urethral strictures: A systematic review and meta-analysis of management modalities.

OBJECTIVE: To evaluate the management methods of female urethral stricture (FUS) and analyze the outcomes of surgical treatments. A meta-analysis was done in an attempt to identify the best approach of urethroplasty and the graft-of-choice. MATERIALS AND METHODS: A systematic search of Pubmed/Medline and Embase databases was performed according to the Preferred Reporting Items For Systematic Review And Meta-Analysis statement, for articles reporting on FUS management in the last decade. The Newcastle-Ottawa scale was used to assess the quality of 28 included non-randomized studies. The data on FUS management was summarized and pooled success rates (taken as symptom improvement and no need for further instrumentation) were compared. The secondary outcome was to establish a diagnostic modality of choice and define a "successful-outcome" of repair. RESULTS: The outcome was separately reported for 554 women undergoing surgical intervention for FUS in the literature. The criteria defining FUS were varied. A combination of tests was used for diagnosis as none was singularly conclusive. A total of 301 patients had previous urethral instrumentations. The pooled success rate of urethral dilatation (234 women) was 49% at a mean follow-up of 32 months; flap urethroplasty (108 cases) was 92% at a mean follow-up of 42 months; buccal mucosal graft (BMG) urethroplasty (133 cases) was 89% at a mean follow-up of 19 months; vaginal graft augmentation (44 cases) was 87% at a mean follow-up of 15 months; and labial graft reconstruction (19 cases) was 89% at a mean follow-up of 18.4 months. The dorsal approach of graft augmentation met with 88% (95% confidence interval [CI] 0.79-0.95) success compared with 95% (95% CI 0.86-1) for the ventral approach. CONCLUSION: FUS is a rare condition requiring a meticulous diagnostic workup using multiple tests. All urethroplasties have shown better pooled success rates (86%-93%) compared with dilatation (49%). BMG is equally effective as vaginal graft urethroplasty.

The role of pulse width manipulation compared to program changes alone for unsatisfactory sacral neuromodulation therapy: A retrospective matched-cohort analysis.

AIM: Pulse width (PW) influences neuromodulation by its impact on nerve fiber recruitment. A paucity of data regarding the manipulation of PW in sacral neuromodulation (SNM) exists. This study describes the clinical features and outcomes of PW manipulation for unsatisfactory SNM therapy. METHODS: A retrospective, single-institution review was performed of reprogrammed SNM patients between 2010 and 2019. Two cohorts were created: those with PW changes ± program changes and age-matched controls with program changes alone. Patients lacking follow-up and non-InterStim II models were excluded. RESULTS: Out of 710 SNM interrogations, 147 (20.7%) had PW changes and 80 met inclusion criteria. Most PW changes were shortened (61/80, 76.3%). Clinical features did not differ between cohorts except by indication for reprogramming. The most common indication for PW change was painful stimulation (34/80, 43%), whereas in controls it was suboptimal efficacy (76/80, 95%). Clinical success was stratified by indication. There was a higher improvement in efficacy in the PW cohort (61%, 17/28 vs. 36%, 27/76, p = .02). PW manipulation successfully relieved painful stimulation in 50% (17/34 vs. 0/3, p = .23), which was more likely with a shortened compared to extended PW (14/15, 93.3% vs. 0/6, 0%, p < .01). PW resulted in improvement in localization of the stimulus in 94% (17/18 vs. 0/1, p = .10). The subsequent lead revision or explant was significantly higher in the PW cohort (43% vs. 25%, p = .03). CONCLUSION: PW manipulation may aid the salvage of unsatisfactory SNM therapy. These findings represent an initial assessment of the role of PW in SNM, particularly regarding the efficacy and painful stimuli. The further prospective investigation is warranted.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

17-Year Single Center Retrospective Review of Rate, Risk Factors and Outcomes of Lead Breakage during Sacral Neuromodulation Lead Removal.

PURPOSE: One risk of removal of a tined sacral neuromodulation lead is breakage, resulting in a retained lead fragment. We report lead breakage rates, risk factors and outcomes of retained fragments. MATERIALS AND METHODS: We report on 464 tined lead removals from 2002 to 2018. Clinical and surgical factors were reviewed and appropriate statistical analysis performed. Retained fragments were reviewed for fragment description and long-term complications. RESULTS: A total of 464 tined lead removals were included, with 35 lead breaks identified, for a rate of 7.5% (35). Factors associated with breakage included male gender (OR 6.58, 95% CI 2.54-17.01, p=0.001) and diabetes (OR 2.42, 95% CI 1.05-5.58, p=0.019). A shorter time since implantation was protective (OR 0.86, 95% CI 0.76-0.98, p=0.002). There was no difference in breakage rate based on age, weight, history of prior revision, bilateral leads, reason for lead removal, surgical technique or surgeon. Of the 35 breaks 27 had imaging available. Of these 66% (18) broke in the tined region and 81% (22) were ghost leads. Most patients (80%, 28 of 35) with retained lead fragments received another implant. Only 1 patient had a related complication of additional surgery for pain related to the fragment. CONCLUSIONS: There is a low rate of tined lead breakage during lead removal. However, it is higher than the manufacturer estimate. Protective factors include a shorter time between implant and lead revision. The most common location for lead breakage is in the region of the tines, most are ghost fragments and long-term complications are uncommon.

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.