Bladder outlet obstruction in women: Advanced evaluation.

INTRODUCTION: Herein, we provide a review of the indications, practical considerations, and interpretation of urodynamics (UDS) with or without fluoroscopy, as well as cystourethroscopy, for women with suspected bladder outlet obstruction (BOO). METHODS AND RESULTS: A narrative review was performed focusing on the current primary literature and society guidelines around advanced diagnostic modalities for female BOO patients. UDS studies help diagnose BOO by identifying high-pressure low-flow voiding patterns and/or the characteristic radiographic appearance of the bladder neck and urethra during micturition. Cystourethroscopy aids in evaluating structural aberrations of the bladder outlet, and in surgical planning. CONCLUSIONS: UDS studies and cystourethroscopy are useful adjuncts in carefully-selected female patients with suspected BOO.

Melatonin and melatonin receptor agonists in the treatment of nocturia: A systematic review.

AIM: Causes of nocturia may extend beyond primary bladder pathology and it has been commonly associated as a side effect of sleep disorders. This has led to the study of melatonin and melatonin receptor agonists as a primary treatment for nocturia hypothesized to be secondary to sleep disorders. We aim to systematically review the efficacy and reported safety of melatonin and melatonin receptor agonists in the treatment of nocturia. METHODS: A search strategy of EMBASE and Pubmed/Medline databases was utilized to identify eligible studies. Two thousand and twenty-eight unique references were identified in concordance with the Preferred Reporting Items of Systematic Reviews and Meta-Analyses guidelines for systematic reviews, of which nine papers met the inclusion criteria. The Cochrane Collaboration risk of bias criteria in the open label and nonplacebo studies was used to assess bias. RESULTS: The nine studies identified included 3 randomized double-blinded placebo-controlled trials, 2 randomized non-placebo trial, and 4 prospective open-label trials. Three utilized the melatonin-receptor agonist ramelteon (8 mg) and six utilized melatonin (four 2 mg extended release, two 2 mg normal release). Nocturia improved in 8 studies varying from moderate to low efficacy related to reduction in nocturia episodes. Five studies evaluated sleep parameters finding improvement in both nocturia and sleep quality. Male subjects represented 76.8% of 371 total subjects in prospective and randomized trials. Ramelteon and melatonin were both reported as well tolerated during nocturia treatment. A meta-analysis was not able to be performed due to the heterogeneity of bladder diagnoses. CONCLUSIONS: At this time, there is insufficient evidence to routinely recommend melatonin as an effective treatment for nocturia given the limitations of current clinical studies. Randomized placebo-controlled trials and prospective open label studies in non-neurogenic populations report a trend towards nocturia improvement with good tolerability and rare side effects. Therefore, further larger scale randomized trials with focused urologic diagnoses in well-characterized patient populations are warranted.

Efficacy and safety of onabotulinumtoxinA for the treatment of overactive bladder in men and women: A pooled analysis.

BACKGROUND: This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). METHODS: Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. RESULTS: In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. CONCLUSION: OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.

Outcomes of women diagnosed with primary bladder neck obstruction based on video urodynamic criteria.

OBJECTIVE: Functional and anatomic bladder outlet obstruction (BOO) in women are more prevalent than previously suspected and remain a diagnostic challenge. Several urodynamic diagnostic criteria for female BOO have been proposed, but studies validating the criteria by assessing treatment outcomes are lacking. We sought to correlate video urodynamic (VUD) diagnostic criteria with symptom improvement in women with functional bladder outlet obstruction. METHODS: A retrospective cohort study of women diagnosed with primary bladder neck obstruction (PBNO) by VUD criteria who underwent bladder neck incision (BNI) between 2010 and 2022 was performed. Patient demographic, clinical, and urodynamic characteristics were collected before and after treatment and analyzed. RESULTS: Twenty-six women with mean age 64.7 years underwent BNI. Nineteen patients (73.1%) were cured, four (15.4%) improved, and three (11.5%) failed. After BNI the mean postoperative Qmax was significantly higher (9.4 vs. 3 mL/s, p = 0.006) and mean postvoid residual (PVR) was significantly lower (102 vs. 514 mL, p ≤ 0.001). Patients who did not require a catheter preoperatively were more likely to be cured than those who did (90% vs. 62.5%, p = 0.03). The PdetQmax of patients that were cured or improved did not differ significantly from those who were not (50.7 cm H2 O vs. 32 cm H2 O, p = 0.21). CONCLUSIONS: The diagnosis of PBNO by VUD criteria for obstruction correlated with treatment outcomes with success in 88.5% and 56% becoming catheter independent. Successful treatment was independent of preoperative PdetQmax.

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

Sensation of incomplete bladder emptying in women: Lack of correlation to an elevated post-void residual.

INTRODUCTION/BACKGROUND: Sensation of incomplete bladder emptying (SIBE) has been shown to be correlated with an elevated post-void residual (PVR) in men, however, the significance of this symptom and whether it correlates with an elevated PVR in women is less clear. In this study, we assessed if SIBE in women is correlated with an elevated PVR and determined the relationship of SIBE to other lower urinary tract symptoms. METHODS/MATERIALS: Women ages ≥18 with lower urinary tract symptoms were eligible. SIBE was defined by a response "sometimes", "most of the time", or "all of the time" to the question "How often do you feel that your bladder has not emptied properly after you have urinated?" on the International Consultation on Incontinence Questionnaire. Frequency and bother of other lower urinary tract symptoms were also assessed to compare their relationship to SIBE. Elevated PVR was defined as ≥100 ml via ultrasound. RESULTS: We prospectively evaluated 95 women, 59% of whom reported SIBE. Compared to women without SIBE, women with SIBE reported more urinary hesitancy (51% vs. 18%, p = 0.002), intermittency (56% vs. 16%, p < 0.001), weak stream (36% vs. 5%, p < 0.001), dysuria (29% vs. 5%, p = 0.004), and straining (25% vs 5%, p = 0.013). However, there was no difference in elevated PVRs between women with and without SIBE [5/56, 9% vs. 4/39, 10%, (p = 0.99)]. All women, regardless of SIBE, reported higher bother from storage and incontinence symptoms versus voiding symptoms with no difference in overall bother scores. CONCLUSION: SIBE is a common complaint in women with lower urinary tract symptoms. While women with SIBE reported more voiding symptoms, they were more bothered by storage symptoms. Importantly, most of these women emptied their bladder well and were not more likely to have an elevated PVR than women without SIBE.

Diagnosis and management of overactive bladder: A review.

AIM: Overactive bladder (OAB) is a common and troublesome condition that can significantly impair quality of life. This review aims to educate providers of obstetrics and gynecology services about available therapies for OAB and what to expect following treatment. METHODS: Here, we review published data from studies that have evaluated available treatments for OAB. Relevant articles published over the past 2 decades, including large multicenter trials, were identified through a literature search using PubMed.gov, and the references in those articles were also manually searched to find additional articles. Treatment guidelines and product labels were also reviewed. RESULTS: Behavioral therapy is recommended as a first choice for OAB management; pharmacologic treatment (anticholinergics, ß3 -adrenoceptor agonists) as second-line treatment; and onabotulinumtoxinA, peripheral tibial nerve stimulation, and sacral nerve stimulation as third-line therapy for patients refractory or intolerant to first- and second-line treatments. A stepwise approach to treatment through first-, second-, and third-line therapies is recommended, recognizing this may not be appropriate for all patients. CONCLUSIONS: To optimize symptom control and set realistic expectations, patients should be carefully monitored and counseled appropriately on available treatment options.

Radiation exposure during videourodynamic testing: Is dose reduction possible using a standardized protocol?

AIMS: To evaluate the impact of a protocol for standardized image capture during video urodynamics (VUD) on radiation exposure. Secondly, to categorize radiation exposure by condition warranting VUD and to identify clinical variables that correlate with increased radiation exposure. METHODS: One hundred fifty patients underwent VUD using our standardized protocol. All images were taken using low dose and pulsed settings. Four images are captured: one scout image, one filling image, one voiding image, and one post-void image. If the patient is unable to void with the catheter in place, the catheter is removed and a second image is taken during an attempt at unintubated flow. If vesicoureteral reflux (VUR) is identified, an alternate protocol is entered to document parameters. The mean radiation exposure measured in dose area product (DAP), fluoroscopy time, and number of images were noted and compared with previously published fluoroscopy data collected at our institution before protocol implementation. RESULTS: The mean fluoroscopy exposure after the implementation of our protocol was 273.5 mGy/cm2 taking 5.2 images in 4.5 seconds. Protocol implementation leads to a 51.2% reduction in radiation exposure calculated by mean DAP (P < .0001) and a 96.5% reduction in fluoroscopy time (P < .0001). The presence of VUR, fluoroscopy time, and body mass index (BMI) > 25 were associated with higher radiation exposure (P < .0001). CONCLUSION: Implementation and adherence to a standardized protocol for fluoroscopy led to a reduction in radiation exposure fluoroscopy time. The presence of VUR, fluoroscopy time, and BMI > 25 were associated with higher radiation exposure.

Evaluating the safety and potential activity of URO-902 (hMaxi-K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non-neurogenic) overactive bladder syndrome and detrusor overactivity from two double-blind, imbalanced, placebo-controlled randomized phase 1 trials.

AIMS: Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit. METHODS: ION-02 (intravesical instillation) and ION-03 (direct injection) were double-blind, placebo-controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety. ION-02 participants received either 5000 µg or 10 000 µg URO-902, or placebo. ION-03 participants received either 16 000 or 24 000 µg URO-902, or placebo, injected directly into the bladder wall using cystoscopy. Primary outcome variables were safety parameters occurring subsequent to URO-902 administration; secondary efficacy variables also were evaluated. RESULTS: Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, in ION-02 (N = 21), involuntary detrusor contractions on urodynamics at 24 weeks in patients receiving URO-902 (P < .0508 vs placebo) and mean urgency incontinence episodes in the 5000 µg group (P = .0812 vs placebo) each showed a downward trend. In ION-03 (N = 13), significant reduction versus placebo in urgency episodes (16 000 µg, P = .036; 24 000 µg, P = .046) and number of voids (16 000 µg, -2.16, P = .044; 24 000 µg, -2.73, P = .047) were observed 1 week after injection. CONCLUSION: Promising safety and efficacy results in these preliminary phase 1 studies suggest gene transfer may be a promising therapy for OAB/DO, warranting further investigation.

Impact of preoperative urodynamics on women undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Preoperative urodynamic studies (UDS) are frequently performed before pelvic organ prolapse (POP) surgery to assess urethral and bladder function. The primary goal of this study is to examine how preoperative UDS are utilized and what value these studies have in patient treatment and/or counseling. METHODS: We retrospectively reviewed patients who underwent prolapse surgery and had preoperative UDS between June 2010 and February 2015. Indications for UDS were classified into four categories: (1) occult stress urinary incontinence only, (2) overactive bladder symptoms, (3) mixed or insensible urinary incontinence, and (4) voiding symptoms and/or elevated post-void residual. We identified changes in management or counseling that were directly attributable to UDS results prior to surgery. RESULTS: Three hundred ninety-two patients underwent urodynamic testing for indications 2-4 above, and 316 met the inclusion criteria. Fifty-seven percent (180/316) had OAB symptoms (34.4% wet, 65.6% dry), 40.2% (127/316) had mixed incontinence, and 17.1% (54/316) had voiding symptoms and/or elevated PVR. A total of 3.5% (11/316) patients had alteration in their management or counseling based on the results of the UDS; 29.4% (50/170) of the women evaluated for occult SUI alone or with other symptoms demonstrated it and 41 underwent sling placement. CONCLUSIONS: UDS did not have a significant impact on preoperative management or counseling in POP surgery if demonstration of occult SUI was not the indication for preoperative study in women committed to POP surgery. Major alterations in treatment were rare and occurred mostly in women with stress incontinence that also had concomitant voiding symptoms and/or elevated PVR.

Incontinence after Prostate Treatment: AUA/SUFU Guideline.

PURPOSE: Urinary incontinence after prostate treatment (IPT) is one of the few urologic diseases that is iatrogenic, and, therefore, predictable and perhaps preventable. Evaluation of the incontinent patient, risk factors for IPT, the assessment of the patient prior to intervention, and a stepwise approach to management are covered in this guideline. Algorithms for patient evaluation, surgical management, and device failure are also provided. MATERIALS AND METHODS: This guideline was developed using a systematic review from the Mayo Clinic Evidence Based Practice Center with additional supplementation by the authors. A research librarian conducted searches from 2000 to December 21st, 2017 using Ovid, MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Databases of Systematic Reviews. Additional references through 12/31/2018 were identified. RESULTS: This guideline was developed by a multi-disciplinary panel to inform clinicians on the proper assessment of patients with IPT and the safe and effective management of the condition in both surgical and non-surgical contexts. Statements guiding the clinician on proper management of device failure are also included. CONCLUSION: Most patients who undergo radical prostatectomy (RP), and some patients who undergo radiation therapy (RT) or surgery for benign prostatic hyperplasia (BPH), will experience IPT. Although non-surgical options, such as pelvic floor muscle exercises (PFME), can hasten continence recovery, patients who remain incontinent at one-year post-procedure, or have severe incontinence at six months, may elect to undergo surgical treatment (e.g. artificial urinary sphincter). Prior to IPT surgery, the risks, benefits, alternatives, and additional likely procedures should be discussed with the patient.

Diagnosis and management of nocturia in current clinical practice: who are nocturia patients, and how do we treat them?

OBJECTIVE: To characterize the current evaluation, and efficacy of treatments in patients with the primary complaint of nocturia. METHODS: A retrospective chart review was performed of new patient encounters seen in a tertiary urology practice from May 2010 to September 2016 with the primary diagnosis of nocturia (ICD-9 788.43 and ICD-10 R35.1). RESULTS: 595 patients were identified. 403 met inclusion criteria. The median patient reported that nocturia episodes were 4 (1-20). 192 patients (48%) reported previous treatment for nocturia. After the index visit, a bladder diary (BD) was utilized in 50% of patients, with a 62% (n = 124) completion rate at follow-up visit. On BD analysis, the most common etiologies of nocturia were nocturnal polyuria 76% (n = 90) and overactive bladder in 21% (n = 26). Patient reported improvement with therapy after BD completion was 46% (n = 34), similar to patients without voiding diaries (43% improvement, n = 153). Anticholinergics and alpha blockers were the most commonly recommended drug, but no specific medication was associated with nocturia improvement. Oral desmopressin was used in 5% of patients. CONCLUSION: Nocturia is a common condition and very commonly patients have sought treatment prior to presentation. Bladder diaries were recommended to half of the patients. Patient reported that improvement did not seem to correlate with completion of a bladder diary. Though most patients had NP the use of desmopressin was very low. Current treatments used in managing nocturia may lack efficacy.

AMS-800 Artificial urinary sphincter in female patients with stress urinary incontinence: A systematic review.

AIMS: To perform a systematic review of studies reporting the outcomes of AMS-800 artificial urinary sphincter (AUS) implantation in female patients with stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). METHODS: A systematic literature search of the Medline and Embase databases was performed in June 2018 in accordance with the PRISMA statement. No time limit was used. The protocol was registered in PROSPERO (CRD42018099612). Study selection and data extraction were performed by two independent reviewers. RESULTS: Of 886 records screened, 17 were included. All were retrospective or prospective non-comparative case series. One study reported on vaginal AUS implantation, 11 on open AUS implantation, two on laparoscopic AUS implantation, two on robot-assisted AUS implantation and one compared open and robot-assisted implantations. The vast majority of patients had undergone at least one anti-incontinence surgical procedure prior to AUS implantation (69.1-100%). The intraoperative bladder neck injury rates ranged from 0% to 43.8% and the intraoperative vaginal injury rates ranged from 0 to 25%. After mean follow-up periods ranging from 5 to 204 months, the complete continence rates ranged from 61.1% to 100%. The rates of explantation, erosion and mechanical failure varied from 0% to 45.3%, 0% to 22.2% and 0% to 44.1%, respectively. CONCLUSIONS: AMS-800 AUS can provide excellent functional outcomes in female patients with SUI resulting from ISD but at the cost of a relatively high morbidity. High level of evidence studies are needed to help better define the role of AUS in the female SUI armamentarium.

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder.

AIMS: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry. METHODS: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity. RESULTS: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) were high. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies. CONCLUSIONS: The validity and reliability of the ICIQ-UAB were supported in a pilot study setting and the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies.

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

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

Outcomes of intradetrusor onabotulinum toxin A injection in patients with Parkinson's disease.

OBJECTIVE: To assess the safety and efficacy of intradetrusor onabotulinum toxin A injections for the treatment of overactive bladder (OAB) in patients with Parkinson's disease (PD). METHODS: All PD patients who underwent intradetrusor injections of onabotulinum toxin A (BoNT-A) for storage symptoms between 2010 and 2017 were included in a retrospective study. A 100 U dose of BoNT-A (Botox®, Allergan Irvine, CA) was used for the first injection in all patients. The primary endpoint was clinical success defined as any subjective improvement in OAB symptoms self-assessed by the patients 4 weeks after the injections. RESULTS: Out of 24 patients analyzed, 19 reported improvement of their OAB symptoms 4 weeks after the first injection (79.2%) with complete resolution of urgency urinary incontinence in seven patients (29.1%; P < 0.001). The average post-void residual (PVR) increased significantly after the first injection from 17.6 to 125.3 mL (P < 0.001). Three of the patients had to start clean intermittent catheterization (CIC) after the first injection (12.5%). Out of 49 injections in total, only five caused incomplete bladder emptying requiring the use of CIC (10.2%). Higher pre-injection PVR was significantly associated with both a lower chance of symptomatic improvement (P = 0.04) and a higher risk of incomplete bladder emptying with institution of CIC (P = 0.047). CONCLUSION: Intradetrusor injections of BoNT-A 100 U appeared as a safe and effective option in PD patients with OAB symptoms and a low PVR before the injection. Higher preoperative PVR was the strongest predictor of both treatment failure and postoperative urinary retention requiring CIC.

OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial.

PURPOSE: Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics. MATERIALS AND METHODS: Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed. RESULTS: OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (-2.65 vs -0.87, p <0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p <0.001). All other overactive bladder symptoms improved vs placebo (p ≤0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p <0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed. CONCLUSIONS: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Use of Concomitant Stress Incontinence Surgery at Time of Pelvic Organ Prolapse Surgery Since Release of the 2011 Notification on Serious Complications Associated with Transvaginal Mesh.

PURPOSE: There is controversy regarding the performance of concomitant anti-incontinence procedures at the time of pelvic organ prolapse repair. Data support improvement in stress urinary incontinence with a concomitant sling but increased adverse events. We assessed trends in preoperative stress urinary incontinence evaluation, concomitant anti-incontinence procedure at pelvic organ prolapse surgery and postoperative anti-incontinence procedures at our institution before and after the 2011 FDA (U.S. Food and Drug Administration) Public Health Notification pertaining to vaginal mesh. MATERIALS AND METHODS: We retrospectively reviewed the records of patients who underwent pelvic organ prolapse surgery from 2009 to 2015. Preoperative workup included assessment of subjective stress urinary incontinence and/or evaluation for leakage with reduction of pelvic organ prolapse on physical examination, urodynamics or a pessary trial. The percentages of concomitant and postoperative anti-incontinence procedures were compared before and after the 2011 FDA notification. RESULTS: A total of 775 women underwent pelvic organ prolapse repair. The percentage of anti-incontinence procedures at pelvic organ prolapse repair decreased from 54.8% to 38.0% after the FDA notification (p = 0.002) while the incidence of preoperative objective stress urinary incontinence on examination, urodynamics and pessary trials remained constant. The incidence of postoperative anti-incontinence procedures within 1 year of the index surgery remained low. CONCLUSIONS: We found a decrease in the incidence of concomitant anti-incontinence procedures at the time of pelvic organ prolapse repair following the 2011 FDA notification despite no significant decline in subjective stress urinary incontinence or demonstrable stress urinary incontinence on preoperative evaluation. Further analysis is warranted to assess the impact of the FDA notification on treatment patterns in women with pelvic organ prolapse and stress urinary incontinence.

Risk Factors for Urinary Tract Infection following Mid Urethral Sling Surgery.

PURPOSE: Mid urethral sling surgery is common. Postoperative urinary tract infection rates vary in the literature and independent risk factors for urinary tract infection are not well defined. We sought to determine the incidence of and risk factors for urinary tract infection following mid urethral sling surgery. MATERIALS AND METHODS: A retrospective cohort of females who underwent sling surgery was captured from the 2006 to 2014 NSQIP® (National Surgical Quality Improvement Program®) database. Exclusion criteria included male gender, nonelective surgery, totally dependent functional status, preoperative infection, prior surgery within 30 days, ASA® (American Society of Anesthesiologists®) Physical Status Classification 4 or greater, concomitant procedure and operative time greater than 60 minutes. The primary outcome was the incidence of urinary tract infection within 30 days of mid urethral sling surgery. Risk factors for urinary tract infection were assessed by examining patient demographic, comorbidity and surgical variables. Logistic regression analyses were performed to estimate the ORs of individual risk factors. Multivariable logistic regression was then performed to adjust for confounding. RESULTS: A total of 9,022 mid urethral sling surgeries were identified. The urinary tract infection incidence was 2.6%. Factors independently associated with an increased infection risk included age greater than 65 years (OR 1.54, 95% CI 1.07-2.22), body mass index greater than 40 kg/m2 (OR 1.89, 95% CI 1.23-2.92) and hospital admission (OR 2.06, 95% CI 1.37-3.11). Mid urethral sling surgery performed by urologists carried a reduced risk of infection compared to the surgery done by gynecologists (OR 0.52, 95% CI 0.40-0.69). CONCLUSIONS: The urinary tract infection risk following mid urethral sling surgery in NSQIP associated hospitals is low. Novel patient and surgical factors for postoperative urinary tract infection have been identified and merit further study.

Long-Term Treatment with OnabotulinumtoxinA Results in Consistent, Durable Improvements in Health Related Quality of Life in Patients with Overactive Bladder.

PURPOSE: We present the long-term effects of repeat onabotulinumtoxinA 100 U treatment on health related quality of life in patients with overactive bladder and urinary incontinence who had an inadequate response to and/or were intolerant of an anticholinergic. MATERIALS AND METHODS: Patients who completed either of 2, 24-week phase III trials could enter a 3-year extension study and request multiple onabotulinumtoxinA 100 U treatments as needed. Results of the I-QOL (Incontinence-Quality of Life) and KHQ (King's Health Questionnaire) are reported for up to 6 treatments. Consistency of the response to repeat onabotulinumtoxinA treatments was evaluated by classifying patients by the I-QOL response to the first treatment and analyzing responses to treatments 2 to 6. RESULTS: After onabotulinumtoxinA treatments 1 to 6, improvements in I-QOL scores were consistently 2 to 3 times the minimally important difference, and improvements in KHQ role limitations and social limitations domain scores were 5 to 6 and 3 to 4 times the minimally important difference, respectively. Most patients achieved or exceeded the minimally important difference for I-QOL and KHQ domain scores. Furthermore, 72.9% of patients who achieved or exceeded the minimally important difference for I-QOL after treatment 1 did so for all subsequent treatments. Of patients with a poor response after treatment 1, 38.3% achieved improvements greater than the minimally important difference for all subsequent treatments. CONCLUSIONS: In patients with overactive bladder and incontinence consistent and clinically meaningful improvements in health related quality of life were observed with repeat onabotulinumtoxinA 100 U treatments. A positive response after treatment 1 tended to predict similar responses to subsequent treatments, whereas a lack of response to treatment 1 did not preclude positive response(s) to later treatments.