Antibiotic use, best practice statement adherence, and UTI rate for intradetrusor onabotulinumtoxin-A injection for overactive bladder: A multi-institutional collaboration from the SUFU Research Network (SURN).

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is a well-established treatment for overactive bladder (OAB). The American Urological Association (AUA) 2008 Antibiotic Best Practice Statement (BPS) recommended trimethoprim-sulfamethoxazole or fluoroquinolone for cystoscopy with manipulation. The aim of the study was to evaluate concordance with antibiotic best practices at the time of BTX-A injection and urinary tract infection (UTI) rates based on antibiotic regimen. METHODS: Men and women undergoing first-time BTX-A injection for idiopathic OAB with 100 units in 2016, within the SUFU Research Network (SURN) multi-institutional retrospective database were included. Patients on suppressive antibiotics were excluded. The primary outcome was concordance of periprocedural antibiotic use with the AUA 2008 BPS antimicrobials of choice for "cystoscopy with manipulation." As a secondary outcome we compared the incidence of UTI among women within 30 days after BTX-A administration. Each outcome was further stratified by procedure setting (office vs. operating room; OR). RESULTS: Of the cohort of 216 subjects (175 women, 41 men) undergoing BTX-A, 24 different periprocedural antibiotic regimens were utilized, and 98 (45%) underwent BTX-A injections in the OR setting while 118 (55%) underwent BTX-A injection in the office. Antibiotics were given to 86% of patients in the OR versus 77% in office, and 8.3% of subjects received BPS concordant antibiotics in the OR versus 82% in office. UTI rates did not vary significantly among the 141 subjects who received antibiotics and had 30-day follow-up (8% BPS-concordant vs. 16% BPS-discordant, CI -2.4% to 19%, p = 0.13). A sensitivity analysis of UTI rates based on procedure setting (office vs. OR) did not demonstrate any difference in UTI rates (p = 0.14). CONCLUSIONS: This retrospective multi-institutional study demonstrates that antibiotic regimens and adherence to the 2008 AUA BPS were highly variable among providers with lower rates of BPS concordant antibiotic use in the OR setting. UTI rates at 30 days following BTX-A did not vary significantly based on concordance with the BPS or procedure setting.

Incomplete bladder emptying and urinary tract infections after botulinum toxin injection for overactive bladder: Multi-institutional collaboration from the SUFU research network.

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is an effective therapy for overactive bladder (OAB), however, adverse events may prevent patients from initiating therapy. The study objective was to report real-world rates of incomplete emptying and urinary tract infection (UTI) in men and women undergoing BTX-A for OAB. METHODS: Eleven clinical sites performed a retrospective study of adults undergoing first-time BTX-A injection (100 units) for idiopathic OAB in 2016. Exclusions included: postvoid residual (PVR) > 150 ml, prior BTX-A, pelvic radiation, or need for preprocedure catheterization. Primary outcomes at 6 months were incomplete emptying (clean intermittent catheterization [CIC] or PVR ≥ 300 ml without the need for CIC); and UTI (symptoms with either positive culture or urinalysis or empiric treatment). We compared rates of incomplete emptying and UTI within and between sexes, using univariate and multivariable models. RESULTS: 278 patients (48 men and 230 women) met inclusion criteria. Mean age was 65.5 years (range: 24-95). 35% of men and 17% of women had incomplete emptying. Men had 2.4 (95% CI: 1.04-5.49) higher odds of incomplete emptying than women. 17% of men and 23.5% of women had ≥1 UTI, the majority of which occurred within the first month following injection. The strongest predictor of UTI was a history of prior UTI (OR: 4.2 [95% CI: 1.7-10.3]). CONCLUSIONS: In this multicenter retrospective study, rates of incomplete emptying and UTI were higher than many previously published studies. Men were at particular risk for incomplete emptying. Prior UTI was the primary risk factor for postprocedure UTI.

Urinary retention after AdVance™ Sling: A multi-institutional retrospective study.

AIMS: To identify risk factors for urinary retention following AdVance™ Sling placement using preoperative urodynamic studies to evaluate bladder contractility. METHODS: A multi-institutional retrospective review of patients who underwent an AdVance Sling for post-prostatectomy stress urinary incontinence from 2007 to 2019 was performed. Acute urinary retention (AUR) was defined as the complete inability to void or elevated post-void residual (PVR) leading to catheter placement or the initiation of intermittent catheterization at the first void trial postoperatively. Bladder contractility was evaluated based on preoperative urodynamics. RESULTS: Of the 391 patients in this study, 55 (14.1%) experienced AUR, and 6 patients (1.5%) had chronic urinary retention with a median follow-up of 18.1 months. In total, 303 patients (77.5%) underwent preoperative urodynamics, and there was no significant difference between average PdetQmax (26.4 vs. 27.4 cmH2 O), Qmax (16.6 vs. 16.2 ml/s), PVR (19.9 vs. 28.1 ml), bladder contractility index (108 vs. 103) for patients with or without AUR following AdVance Sling. Impaired bladder contractility preoperatively was not predictive of AUR. Time to postoperative urethral catheter removal was predictive of AUR (odds ratio, 0.83; 95% confidence interval, 0.73-0.94; p = .003). CONCLUSIONS: Chronic urinary retention after AdVance Sling placement is uncommon and acute retention is generally self-limiting. No demographic or urodynamic factors were predictive of AUR. Patients who developed AUR were more likely to have their void trials within 2 days following AdVance Sling placement versus longer initial catheterization periods, suggesting that a longer duration of postoperative catheterization may reduce the occurrence of AUR.

Predictors of Nerve Stimulator Success in Patients With Overactive Bladder.

PURPOSE: To identify factors associated with successful sacral nerve stimulator (SNS) trial after SNS implantation for the treatment of medication refractory overactive bladder (OAB). METHODS: Patients undergoing treatment for OAB at Lahey Hospital and Medical Center between 2004 and 2016 were identified. Patients undergoing SNS placement were identified; SNS success was defined as permanent implantation of the SNS. Demographic, clinical and treatment data were extracted from patient charts; uni- and multivariate analyses were conducted to identify factors associated with SNS treatment success. RESULTS: A total of 128 patients were included. On univariate analysis, male sex, prior diagnosis of benign prostatic hyperplasia, and lower volume at first urge on urodynamics (UDS) were associated with unsuccessful SNS trial. On multivariate analysis, male sex (odds ratio [OR], 0.145; 95% confidence interval [CI], 0.036-0.530) and lower volume at first urge on UDS (OR, 0.982; 95% CI, 0.967-0.995) were associated with unsuccessful SNS trial. A threshold value of 100 mL at first urge during preoperative UDS had a specificity of 0.86 in predicting SNS success in men. CONCLUSION: SNS is frequently successful at relieving OAB symptoms. Male patients and those with lower volumes at first urge on UDS, particularly below 100 mL, are more likely to have an unsuccessful SNS trial. Patients in these groups should be counseled on the lower likelihood of SNS success.

Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the food and drug administration public health notifications.

AIMS: To investigate the possible effects of the Food and Drug Administration (FDA) Public Health Notifications in 2008 and 2011 regarding surgical trends in transvaginal mesh (TVM) placement for stress urinary incontinence (SUI) and related mesh revision surgery in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) practice in tertiary care academic medical centers in the United States. METHODS: Surgical volume for procedures performed primarily by FPMRS surgeons at eight academic institutions across the US was collected using Current Procedural Terminology (CPT) codes for stress urinary incontinence repair and revision surgeries from 2007 to 2013. SAS statistical software was used to assess for trends in the data. RESULTS: There was a decrease in the use of synthetic mesh sling for the treatment of SUI at academic tertiary care centers over the past 7 years; however, this was not statistically significant. While the total number of surgical interventions for SUI remained stable, there was an increase in the utilization of autologous fascia pubovaginal slings (AFPVS). The number of mesh sling revision surgeries, including urethrolysis and removal or revision of slings, increased almost three-fold at these centers. CONCLUSIONS: These observed trends suggest a possible effect of the FDA Public Health Notifications regarding TVM on surgical practice for SUI in academic centers, even though they did not specifically warn against the use of synthetic mesh for this indication. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study. However, such data may provide alternative insights into reasons for the observed trends. Neurourol. Urodynam. 36:1155-1160, 2017. © 2016 Wiley Periodicals, Inc.

Surgical Management of Male Voiding Dysfunction.

Benign prostatic hypertrophy (BPH) is a common cause of voiding dysfunction. BPH may lead to bladder outlet obstruction and resultant troublesome lower urinary tract symptoms. Initial management of BPH and bladder outlet obstruction is typically conservative. However, when symptoms are severe or refractory to medical therapy or when urinary retention, bladder stone formation, recurrent urinary tract infections, or upper urinary tract deterioration occur, surgical intervention is often necessary. Numerous options are available for surgical management of BPH ranging from simple office-based procedures to transurethral operative procedures and even open and robotic surgeries. This article reviews the current, most commonly used techniques available for surgical management of BPH.

Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications.

OBJECTIVE: To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers. MATERIALS AND METHODS: Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods. RESULTS: There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases. CONCLUSION: Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends.

The advance transobturator male sling for post-prostatectomy incontinence: subjective and objective outcomes with 3 years follow up.

AIMS: To determine patient-perceived and clinical outcomes of the AdVance sling at 3 years follow-up in men with post-prostatectomy incontinence (PPI). METHODS: Data was prospectively collected of men with PPI treated with the AdVance male sling between February 2008 and March 2010. Twenty-four-hour pad counts and weights and patient completed validated questionnaires were obtained pre-operatively and at 3 years. The primary outcome was improvement in pad count with secondary outcomes of questionnaire scores and patient perception of success. RESULTS: At a median follow-up of 39 months (IQR: 36-44), we identified 30 men meeting inclusion criteria who had the AdVance male sling placed for mild to severe PPI. Eighteen (60%) patients were cured (no pad usage or one pad for security) and an additional 4 (13%) showed improvement (≥50% reduction in pad usage). Eight (27%) patients failed: six patients underwent seven salvage procedures including urethral bulking with collagen (n = 1), Virtue perineal sling (n = 1), and artificial urinary sphincter (n = 5). There were 16 post-operative complications: 13 Clavien I, 2 Clavien II, and 1 Clavien IIIb. CONCLUSIONS: AdVance male sling is an effective treatment option for PPI evidenced by objective improvements in 24-hr pad count and pad weight and patient perceived success via validated questionnaires.

Correlation of patient perception of pad use with objective degree of incontinence measured by pad test in men with post-prostatectomy incontinence: the SUFU Pad Test Study.

PURPOSE: Many investigators have used the number of pads to determine the severity of post-prostatectomy incontinence and yet the accuracy of this tool remains unproven. We determined whether the patient perception of pad use and urine loss reflects actual urine loss. We also identified a quality of life measure that distinguishes patients by severity of incontinence. MATERIALS AND METHODS: We prospectively enrolled 235 men from a total of 18 sites 6 months or more after radical prostatectomy who had incontinence requiring protection. Patients completed a questionnaire on the perception of pad number, size and wetness, a quality of life question, several standardized incontinence questionnaires and a 24-hour pad test that assessed pad number, size and weight. SPSS® was used for statistical analysis. RESULTS: Perception of the number of pads used closely agreed with the number of pads collected during a 24-hour pad test. Perceived and actual pad size had excellent concordance (76%, p <0.001). Patients with wet and soaked pads had statistically and clinically significantly different pad weights that were uniquely different from each other and from those of patients who were almost dry and slightly wet. Response to the quality of life question separated the men into 4 statistically significantly different groups based on mean 24-hour pad weight. CONCLUSIONS: Patients accurately described the number, size and degree of wetness of pads collected during a 24-hour pad test. These values correlated well with actual urine loss. The single question, "To what extent does urine loss affect your quality of life?" separated men into distinct categories.

Management goals for the spina bifida neurogenic bladder: a review from infancy to adulthood.

Patients with spina bifida require longitudinal urological care as they transition from childhood to adolescence and then to adulthood. Issues important to urological health, such as protection of the upper tracts and prevention of incontinence, need vigilant follow-up throughout the patient's life. As the child ages, additional issues such as sexual functioning also become increasingly important for social integration. Despite this need for regular assessment, many adult patients with spina bifida lose coordinated urological care after leaving specialized pediatric spina bifida clinics. Consequently, urologists frequently encounter an adult patient with spina bifida in practice and they need to understand the basic urological treatment goals and potential complications for this population.

Are multichannel urodynamics required prior to surgery in a woman with stress urinary incontinence?

The National Institute for Clinical Excellence recommends that cystometry need not be performed before conservative therapy for incontinence in women, nor is cystometry routinely recommended in the small group of women with a clearly defined diagnosis of pure stress incontinence. Nonetheless, it is frequently utilized in the assessment of women with stress urinary incontinence in the hope that results will shed light on preoperative risk factors for failure or postoperative voiding dysfunction. The ability of urodynamic studies to characterize these parameters reliably remains under investigation. Because urodynamic studies are invasive, costly, and not always available, it is imperative that its benefit be carefully explored. This review highlights the recent arguments for and against this recommendation.

Multimodal therapy for painful bladder syndrome / interstitial cystitis: pilot study combining behavioral, pharmacologic, and endoscopic therapies.

PURPOSE: We evaluated the effectiveness of combining behavioral therapy, pharmacologic therapy and endoscopic hydrodistension for treating painful bladder syndrome / interstitial cystitis (PBS/IC). MATERIALS AND METHODS: Twenty-five patients with PBS/IC were prospectively enrolled in a pilot multimodal behavioral, pharmacologic and endoscopic treatment protocol. Behavioral modification included diet recommendations, fluid restriction to 64 oz. /day, progressive timed voiding and Kegel exercises. Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg, hydroxyzine 10-20 mg and urised 4 tablets. Patients underwent endoscopic bladder hydrodistention under anesthesia at least 2 weeks after protocol enrollment. Behavioral and pharmacological treatments were continued after the hydrodistention. O'Leary-Sant questionnaire scores were recorded before starting the protocol, after pharmacologic/behavioral therapy, 2 months post-hydrodistension, and at scheduled follow-up. RESULTS: Eighteen patients (72%) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months. All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters. Mean O'Leary-Sant symptom index scores for baseline symptoms, after behavioral/pharmacologic treatment, post-hydrodistension and during follow up were 12.5, 8.6, 7.0, and 6.7 (p < 0.05). Mean O'Leary-Sant problem index scores for baseline, after behavioral/pharmacologic treatment, post-hydrodistention and during follow up were 12.7, 8.9, 6.7, and 7.7 (p < 0.05). CONCLUSION: Our pilot multimodal protocol of behavioral modification, pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores, compared to a pre-treatment baseline. These results should be validated in a larger, placebo controlled trial.

Multimodal therapy for painful bladder syndrome / interstitial cystitis: pilot study combining behavioral, pharmacologic, and endoscopic therapies

Purpose: We evaluated the effectiveness of combining behavioral therapy, pharmacologic therapy and endoscopic hydrodistension for treating painful bladder syndrome / interstitial cystitis (PBS/IC). Materials and Methods: Twenty-five patients with PBS/IC were prospectively enrolled in a pilot multimodal behavioral, pharmacologic and endoscopic treatment protocol. Behavioral modification included diet recommendations, fluid restriction to 64 oz. /day, progressive timed voiding and Kegel exercises. Oral pharmacologic therapy consisted of daily doses of macrodantin 100 mg, hydroxyzine 10-20 mg and urised 4 tablets. Patients underwent endoscopic bladder hydrodistention under anesthesia at least 2 weeks after protocol enrollment. Behavioral and pharmacological treatments were continued after the hydrodistention. O'Leary-Sant questionnaire scores were recorded before starting the protocol, after pharmacologic/behavioral therapy, 2 months post-hydrodistension, and at scheduled follow-up. Results: Eighteen patients (72 percent) completed the pilot multimodal treatment protocol and were followed for a mean of 10.2 months. All patients were female with a median age of 36.3 years and had mean bladder capacity under anesthesia of 836 milliliters. Mean O'Leary-Sant symptom index scores for baseline symptoms, after behavioral/pharmacologic treatment, post-hydrodistension and during follow up were 12.5, 8.6, 7.0, and 6.7 (p < 0.05). Mean O'Leary-Sant problem index scores for baseline, after behavioral/pharmacologic treatment, post-hydrodistention and during follow up were 12.7, 8.9, 6.7, and 7.7 (p < 0.05). Conclusion: Our pilot multimodal protocol of behavioral modification, pharmacologic therapy and endoscopic hydrodistention demonstrated a significant progressive improvement in PBS/IC quality of life scores, compared to a pre-treatment baseline. These results should be validated in a larger, placebo controlled trial.

Spiral sling salvage anti-incontinence surgery for women with refractory stress urinary incontinence: surgical outcome and satisfaction determined by patient-driven questionnaires.

PURPOSE: Female patients with refractory stress urinary incontinence (SUI) are a unique surgical challenge. They undergo multiple surgical procedures and eventually are left with urethral closure and continent diversion as their final option. We previously presented our initial experience of a technique that provides circumferential coaptation of the urethra in patients with severe urethral incompetence due to neurologic injuries or congenital anomalies. This study expands on that experience and reports on the clinical and quality of life of patients after spiral sling placement in a defined population of patients with refractory SUI. METHODS: We prospectively evaluated 46 patients with refractory SUI who had undergone spiral sling placement. The surgical outcome was determined by clinical history and physical examination and, primarily, by patient self-assessment and included validated symptom, bother, and quality-of-life questionnaires. RESULTS: Their mean age was 62 years. The mean follow-up was 15 months. At presentation, the patients had undergone a mean of 2.8 incontinence procedures and wore a mean of 5.5 pads daily. The mean pad use decreased to 1.3 pads daily (P <.05). Preoperatively, the mean severity and bother score from the SUI symptoms was 3.0 and 2.9, respectively (0, none; 3, severe). Postoperatively, these numbers decreased to 1.0 and 0.8 (P <.05). The mean overall improvement in symptoms was 82%. No perioperative complications developed. The procedure failed in 1 patient, who underwent urethral closure with urinary diversion. Two patients underwent repeat proximal spiral sling procedure. CONCLUSIONS: The spiral sling is an effective salvage transvaginal procedure that can be considered for female patients with refractory SUI.

The effects of bilateral caudal epidural S2-4 neuromodulation on female sexual function.

This is a pilot study to evaluate the effects of caudal epidural S2-4 neuromodulation on female sexual function in a population of women with voiding dysfunction. We prospectively studied 36 consecutive female patients who underwent caudal epidural sacral neuromodulation. Patients received the Female Sexual Function Index (FSFI) questionnaire preoperatively and 6 months postoperatively. Six months after permanent implantation, the overall score on the FSFI improved by 52% (p = 0.05). Results were better in patients who underwent the treatment for voiding dysfunction compared to those who had pain as their primary complaint. In this group, the overall score improved by 157% (p = 0.004). Stimulation of S2-4 by bilateral caudal epidural neuromodulation in this small group of women with voiding dysfunction, retention, and/or pelvic pain resulted in self-reported improvements in sexual function. Further studies are needed to evaluate the potential role of S2-4 sacral stimulation in the treatment of female sexual dysfunction.

Short-term results of bilateral S2-S4 sacral neuromodulation for the treatment of refractory interstitial cystitis, painful bladder syndrome, and chronic pelvic pain.

We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain (CPP), painful bladder syndrome, and interstitial cystitis (IC). Thirty consecutive patients (21 female, 9 male) with severe refractory symptoms underwent bilateral S2-S4 sacral neuromodulation for CPP/IC. Patients were evaluated with the O'Leary IC symptom and problem index (ICSI, ICPI), the short form of the Urogenital Distress Inventory (UDI-6), and the RAND 36-item health survey (SF-36) preoperatively and 6 months postoperatively. The mean and minimum follow-up were 15 and 6 months, respectively. Of the 30 patients, 23 (77%) had a successful trial stimulation and were permanently implanted. Among these patients, the ICSI and ICPI scores improved by 35 (p = 0.005) and 38% (p = 0.007), respectively. The pain score improved by 40% (p = 0.04) and the UDI-6 score by 26% (p = 0.05). On average, patients reported a 42% improvement in their symptoms. SF-36 scores did not improve significantly. In refractory patients, bilateral caudal epidural sacral neuromodulation is another possible mode of treatment, which appears to improve both pelvic pain and voiding symptoms.

Bilateral caudal epidural neuromodulation for refractory urinary retention: a salvage procedure.

PURPOSE: Sacral neuromodulation with InterStim is approved for idiopathic urinary retention with a success rate of approximately 69%. To our knowledge currently no alternatives exist for patients in whom S3 neuromodulation fails. We report a new technique and our experience with bilateral caudal epidural neuromodulation in patients in urinary retention in whom unilateral or bilateral S3 InterStim failed. MATERIALS AND METHODS: Eight patients with multifactorial urinary retention in whom S3 InterStim previously failed underwent retrograde placement of bilateral tined leads into the caudal epidural space for sacral nerve stimulation. Patients with a 50% or greater clinical response underwent stage 2 Synergy-Versitrel implantable pulse generator placement. Patients were evaluated with voiding diaries, the Urinary Distress Inventory Questionnaire short form, quality of life assessment, need for catheterization and post-void residual urine preoperatively, and 6 months after implantation. RESULTS: Five of the 8 patients experienced return of micturition and underwent placement of a permanent implantable pulse generator. At 6-month followup 4 of the 5 patients voided to completion. One patient improved more than 50% and now catheterizes once daily with a post-void residual urine of 200 cc. There was a significant decrease in obstructive symptoms on the Urinary Distress Inventory Questionnaire short form and improved overall quality of life. CONCLUSIONS: To our knowledge this is the first report of the use of bilateral caudal epidural neuromodulation for refractory urinary retention. This therapy can be successful in patients in whom prior InterStim therapy failed.