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Demographic and Clinical Variables Associated With Treatment Response in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation

Abstract: PD54-05
Sources of Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development

Introduction

Refractory urgency urinary incontinence (UUI) can be treated with onabotulinumtoxinA and sacral neuromodulation but it is unclear whether treatment response differs based on patient characteristics. The objective was to identify clinical and demographic factors associated with treatment response in women participating in a randomized trial comparing efficacy of these two therapies.

Methods

These data were obtained from the Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA) trial. Adjusting for clinical site, age stratum and treatment, univariable analyses were performed to identify baseline participant characteristics and clinical variables associated with each treatment using two definitions of response: 1) a reduction of mean daily UUIE longitudinally over 6 months 2) ≥50% decrease in UUIE across 6 months. Variables with p≤0.1 were included in multivariable analyses. Linear and logistic regression models were fit to estimate each outcome and reported as mean reductions and adjusted odds ratios (OR) with 95% confidence intervals (CI), respectively.

Results

Variables significantly associated with treatment response on univariable and multivariable analyses are noted in the table. Increasing age, higher BMI and higher baseline IIQ score significantly reduced the chances of achieving ≥50% decrease in UUIEs at 6 months for both treatments with a significantly greater effect noted with age in the onabotulinumtoxinA group. A mean reduction in daily UUIE over 6 months was independently associated with higher baseline HUI scores and greater baseline UUIE per day. Higher health utility index scores also had a greater effect on participants in the onabotulinumtoxinA group. Increasing age was associated with less reduction in UUIE per day.

Conclusions

Six months after treatment, age, BMI, baseline UUIE, IIQ and HUI were similarly associated with treatment response in women undergoing sacral neuromodulation and onabotulinumtoxinA with interesting differential effects noted with age and HUI. This information may assist in counseling patients regarding the efficacy and expectations of these treatment modalities for women with refractory UUI.

Funding

Eunice Kennedy Shriver National Institute of Child Health and Human Development

Authors
Holly E Richter
Cindy Amundsen
Eric Jelovsek
Stephen Erickson
Yuko Komesu
Christopher Chermansky
Norbert Kadima
Deborah Myers
Heidi Harvie
Michael Albo
Dennis Wallace
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