Urgent PC Versus a Generic Posterior Tibial Neurostimulator for Overactive Bladder: A Retrospective Noninferiority Study.

OBJECTIVE: The aim of the study was to determine whether a generic posterior tibial neurostimulator was noninferior to Urgent PC in the treatment of nonneurogenic OAB, urgency urinary incontinence, and mixed urinary incontinence. Secondary outcomes include rates of starting and completing 3 months of maintenance therapy, treatment success after 3 months, and adverse events. METHODS: We performed a retrospective cohort analysis of women whose nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence was treated with either Urgent PC or a generic posterior tibial neurostimulator. Previous research shows a 55% treatment success rate for posterior tibial nerve stimulation (PTNS). To demonstrate noninferiority with a limit of 14% and 80% power, our analysis required 157 patients per group. RESULTS: We included 267 Urgent PC and 234 generic patients and excluded 51 patients from analysis. A per-protocol analysis demonstrated treatment success in 55.3% (121 of 219) of the Urgent PC and 48.6% (85 of 175) of the generic cohort (P = 0.187). An intention-to-treat analysis showed treatment success in 45.3% (121 of 267) of the Urgent PC and 36.3% (85 of 234) of the generic cohort (P = 0.690). There were no significant differences in rates of starting (82.2% vs 78.2%, P = 0.409) or completing (79.9% vs 70.9%, P = 0.129) 3 months of maintenance therapy, treatment success after 3 months (78.5% vs 73.8%, P = 0.485), and adverse events (0.37% vs 0.85%, P = 1.000) in the Urgent PC versus generic group, respectively. CONCLUSIONS: In this cohort of women undergoing PTNS for nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence, the generic neurostimulator demonstrated noninferior rates of treatment success compared with Urgent PC.

Percutaneous Tibial Nerve Stimulation in Diabetic and Nondiabetic Women With Overactive Bladder Syndrome: A Retrospective Cohort Study.

OBJECTIVES: The primary objective of this study was to compare optimal response ("very much better" or "much better" on the Patient Global Impression of Improvement [PGI-I] index) to posterior tibial nerve stimulation (PTNS) for overactive bladder (OAB) in patients with and without diabetes mellitus. Secondary outcomes included longitudinal data regarding PTNS use in patients with diabetes and controls. METHODS: We performed a retrospective cohort analysis of women in our tertiary care center who completed at least 10 weekly and 1 maintenance PTNS treatments for OAB, excluding patients who were treated with PTNS for a non-OAB primary diagnosis. Participants were grouped into those with diabetes mellitus and those without. Previous research demonstrated a 20% difference in subjective response to anticholinergics in persons with diabetes versus persons without diabetes with OAB. To demonstrate a 20% difference in optimal PGI-I with 80% power, our analysis required 92 patients in each group. RESULTS: We identified 356 patients: 96 with diabetes mellitus, and 260 controls. There was no statistically significant difference in the primary outcome, with 43 (44.8%) of 96 persons with diabetes versus 115 (44.2%) of 260 controls demonstrating optimal PGI-I response (P = 0.92). Among patients with diabetes, no baseline variables were found to predict treatment response, including hemoglobin A1c greater than 7%, diabetes with sequelae, or higher Charlson Comorbidity Index. CONCLUSIONS: In women undergoing PTNS for OAB, the optimal PGI-I response rate is similar in patients with and without diabetes.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use.

OBJECTIVES: The aims of this study were to determine predictors of successful pessary fitting and continued pessary use in patients with pelvic relaxation. DESIGN: Retrospective observational study. SETTING AND SUBJECTS: The medical records of 130 consecutive patients evaluated for pessary treatment of pelvic relaxation by a single specially trained nurse practitioner (CRJ) at Kaiser Foundation Hospital, Harbor City, Calif, between May 1, 1997, and June 30, 2002, were retrospectively reviewed. INSTRUMENTS: Voiding diaries, data collection sheet, and questionnaires. METHODS: The medical records of the 130 patients were retrospectively reviewed, and data were recorded on data collection sheets. Patients using pessaries completed a questionnaire to assess treatment effectiveness. RESULTS: Coexisting stress urinary incontinence and previous prolapse and cystocele/rectocele repairs were each found to be independent predictors of unsuccessful pessary fitting. Fifty percent of successfully fitted patients had discontinued pessary use by 24 months. Current pessary users were more likely to have undergone prior pelvic reconstructive surgery (37% vs 13%, P = .02), less likely to require a space-filling pessary (13% vs 37%, P = .03), and more likely to recommend pessary to their friends or family (87% vs 50%, P = .007) compared to patients who discontinued pessary use. CONCLUSIONS: Prior pelvic reconstructive surgery is associated with an increased risk of unsuccessful pessary fitting; however, those patients who are successfully fitted tend to continue pessary use.