Characteristics Associated With Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence

Abstract

Purpose: We sought to identify clinical and demographic characteristics associated with treatment response and satisfaction in women undergoing onabotulinumtoxinA and sacral neuromodulation therapies. Materials and Methods: We analyzed data from the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial. Baseline participant characteristics and clinical variables were associated with 2 definitions of treatment response, including 1) a reduction in mean daily urgency incontinence episodes during 6 months and 2) a 50% or greater decrease in urgency incontinence episodes across 6 months. The OAB-S (Overactive Bladder-Satisfaction) questionnaire was used to assess satisfaction. Results: A greater reduction in mean daily urgency incontinence episodes was associated with higher HUI-3 (Health Utility Index-3) scores in the onabotulinumtoxinA group and higher baseline incontinence episodes (each p <0.001) in the 2 groups. Increased age was associated with a lesser decrease in incontinence episodes in the 2 groups (p <0.001). Increasing body mass index (adjusted OR 0.82/5 points, 95% CI 0.70e0.96) was associated with reduced achievement of a 50% or greater decrease in incontinence episodes after each treatment. Greater age (adjusted OR 0.44/10 years, 95% CI 0.30e0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71e0.99) were associated with reduced achievement of a 50% or greater decrease in urgency incontinence episodes in the onabotulinumtoxinA group only (p <0.001 and 0.041, Accepted for publication April 27, 2017. No direct or indirect commercial incentive associated with publishing this article. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number.

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

“…The study’s SNM group had a greater reduction (−3.5 vs −2.3) in UUIE/d, a similar clinical responder rate following lead placement (84% vs 80%), and higher baseline UUIE/d (5.2 +/− 2.7) vs (3.1 +/− 2.7) than previously reported [11]. Greater reduction in UUIE/d has been associated with higher baseline incontinence episodes when evaluating predictors for success at 6 mo [12]. Over the 24-mo period, 58% of the SNM cohort required reprogramming, and 17% required three or more reprogrammings.…”

A Comprehensive Review of Overactive Bladder Pathophysiology: On the Way to Tailored Treatment

“…Most of the current established treatment options for OAB, such as antimuscarinics, SNM, and botulinum toxin, have been reported to be less effective in patients with metabolic syndrome, or at least less effective than in other patient populations [52][53][54]. In contrast, the β3-adrenoreceptor agonist mirabegron, which was designed initially as an antiobesity drug [55], was found to be equally effective in both obese and nonobese OAB patients [56], and might be well suited for this patient population although dose adjustment may be needed [57].…”

How can we better manage drug‐resistant OAB/DO? ICI‐RS 2018

“…ROSETTA Urinary Markers (RUM) was a planned secondary analysis measuring urinary biomarker levels in women with UUI and controls at baseline and 6 months after either treatment . ROSETTA Predictors was a planned secondary analysis performed to identify baseline clinical and demographic factors associated with treatment response and satisfaction in women participating in ROSETTA …”

“…The primary aim of ROSETTA Predictors was to identify baseline participant characteristics and clinical variables associated with either BTX‐A or SNM using two definitions of response: (a) reduction of mean daily UUIE 6 months after treatment and 2) greater than or equal to 50% reduction in UUIE over 6 months . A greater reduction in mean daily UUIEs was seen in both groups with DO present.…”