Holly E Richter1, C L Amundsen2, S W Erickson3, J E Jelovsek4, Y Komesu5, C Chermansky6, H S Harvie7, M Albo8, D Myers9, W T Gregory10, D Wallace3. 1. University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: hrichter@uabmc.edu. 2. Duke University, Durham, North Carolina. 3. RTI International, Research Triangle Park, North Carolina. 4. Cleveland Clinic, Cleveland, Ohio. 5. University of New Mexico, Albuquerque, New Mexico. 6. Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh. 7. University of Pennsylvania, Philadelphia, Pennsylvania. 8. University of California-San Diego, San Diego, California. 9. Brown University, Providence, Rhode Island. 10. Oregon Health and Science University, Portland, Oregon.
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 0.70-0.96) 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 0.30-0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71-0.99) 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, respectively). In the onabotulinumtoxinA group increased satisfaction was noted with higher HUI-3 score (p = 0.002) but there was less satisfaction with higher age (p = 0.001). CONCLUSIONS:Older women with multiple comorbidities, and decreased functional and health related quality of life had decreased treatment response and satisfaction with onabotulinumtoxinA compared to sacral neuromodulation for refractory urgency incontinence.
RCT Entities:
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 0.70-0.96) 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 0.30-0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71-0.99) 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, respectively). In the onabotulinumtoxinA group increased satisfaction was noted with higher HUI-3 score (p = 0.002) but there was less satisfaction with higher age (p = 0.001). CONCLUSIONS: Older women with multiple comorbidities, and decreased functional and health related quality of life had decreased treatment response and satisfaction with onabotulinumtoxinA compared to sacral neuromodulation for refractory urgency incontinence.
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