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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 InterStim TM 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., (© 2023 Wiley Periodicals LLC.)

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., (© 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

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., (© 2019 Wiley Periodicals, Inc.)

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., (© 2016 Wiley Periodicals, Inc.)

Following use of botulinum toxin in the 1980s for the treatment of detrusor sphincter dyssynergia in patients with spinal cord injury (SCI), the potential therapeutic value of this neurotoxin in urology has been the subject of much interest. The DIGNITY (Double-blind InvestiGation of purified Neurotoxin complex In neurogenic deTrusor overactivitY) clinical research program aimed to compare onabotulinumtoxinA with placebo in terms of efficacy and safety in patients with neurogenic detrusor overactivity (NDO) due to SCI or multiple sclerosis. The EMBARK clinical research program mirrored these aims in patients with overactive bladder with urinary incontinence (UI). Each program comprised two phase III, randomized, placebo-controlled studies. In all four trials, primary efficacy endpoints were met, and significant benefits of onabotulinumtoxinA versus placebo were demonstrated across a range of secondary endpoints, including measures of health-related quality of life. The most common adverse event across both programs was urinary tract infection. Interim analyses of data from ongoing long-term extensions to these phase III trials have provided promising evidence for the efficacy of repeated injections. While further investigation is recommended to enrich the dataset, the available evidence indicates that onabotulinumtoxinA provides an effective treatment option for these two populations, which were previously considered very difficult to treat., (© 2014 Wiley Periodicals, Inc.)

Independent rectal contractions are frequently noted when performing multichannel urodynamics and are often considered to be artifactual. In an effort to determine if this activity is indeed significant, we reviewed 430 consecutive multichannel urodynamic studies performed on 289 patients. All studies were performed using an analog recorder at 0.5 mm/sec paper speed. Multichannel pressures included total vesical pressure measured by a urethral catheter, total abdominal pressure measured by a rectal balloon catheter, subtracted detrusor pressure (vesical minus abdominal), and uroflow measurement when possible. Rectal contractions were defined as multiple fluctuations in abdominal pressure as measured by the rectal balloon catheter which were independent of changes in total vesical pressure. These fluctuations could not be reproduced by abdominal stressing or Kegel-type maneuvers. Contractions were noted to be of high or low amplitude, continuous or intermittent. Of the 289 patients, 109 (38%) had a study positive for rectal contractions. Similarly, 168 of 430 studies (38%) were positive. In patients with neurologic disease, rectal contractions were noted in 61/120 (51%). In patients with no history of neurologic disease, 48/169 (29%) had rectal contractions (P < 0.001). Furthermore, when patients without a history of neurologic disease were evaluated with respect to the presence of detrusor instability, a positive study was noted in 27/67 (40%) with instability but in only 21/102 (21%) of patients without instability (P = 0.005). Rectal contractions also occurred with a higher frequency in patients with bladder hyperactivity of any etiology.(ABSTRACT TRUNCATED AT 250 WORDS)

The AUA symptom index is widely used to access patients with suspected benign prostatic hyperplasia (BPH). In order to determine how well symptoms as assessed by this index correlate with urodynamic findings, we evaluated 83 patients referred to our urology clinics with symptoms of BPH. All patients completed the AUA symptom index and then underwent a multichannel urodynamic evaluation. Patients were classified as obstructed, unobstructed, or equivocal according to the Abrams Griffiths nomogram. The AUA symptom index was recorded as the total score and, for purposes of symptom classification, further subdivided into an obstructive score (questions 3, 5, and 6) and an irritative score (questions 1, 2, 4, and 7). The mean age of the 83 patients was 67 (45-84). The mean total AUA symptom score was 16.6 (6-34), mean obstructive score was 6.1 (0-15), and the mean irritative score 10.4 (3-20). Pressure flow analysis using the Abrams-Griffiths nomogram classified 28 patients (34%) as obstructed, 17 (20%) as unobstructed, and 38 (46%) as equivocal. Using the analysis of variance procedure (ANOVA) there was no statistically significant difference in the mean total (P = 0.446), obstructive (P = 0.979), or irritative (P = 0.136) scores. Detrusor instability was present in 45 patients (54%). While total and obstructive scores were not significantly different in patients with detrusor instability vs. those with stable bladders, irritative scores were higher in patients with instability (P = 0.028) using the T-test procedure. Using ANOVA, the difference in post void residual (PVR) between the groups was not quite statistically significant (P = 0.057).(ABSTRACT TRUNCATED AT 250 WORDS)