Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence.
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2017-10
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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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Richter, Holly E, CL Amundsen, SW Erickson, JE Jelovsek, Y Komesu, C Chermansky, HS Harvie, M Albo, et al. (2017). Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence. J Urol, 198(4). pp. 890–896. 10.1016/j.juro.2017.04.103 Retrieved from https://hdl.handle.net/10161/15111.
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Cindy Louise Amundsen
- Treatment with a minimally invasive neural modulation system (sacral and posterior tibial nerve) for control of urinary continence
- Application of botox therapy for urinary urge incontinence
- Evaluation and treatment for nocturnal voiding
- Application of nerve stimulation for urinary retention
- Minimally invasive prolapse surgery for pelvic organ prolapse repairs
- Treatment for stress urinary incontinence with minimally invasive techniques
- Evaluation of the urinary microbiome as it relates to recurrent urinary tract infections and lower urinary tract symptoms
John E Jelovsek
Dr. Jelovsek is the F. Bayard Carter Distinguished Professor of OBGYN at Duke University and serves as Director of Data Science for Women’s Health. He is Board Certified in OBGYN by the American Board of OBGYN and in Female Pelvic Medicine & Reconstructive Surgery by the American Board of OBGYN and American Board of Urology. He has an active surgical practice in urogynecology based out of Duke Raleigh. He has expertise as a clinician-scientist in developing and evaluating clinical prediction models using traditional biostatistics and machine learning approaches. These “individualized” patient-centered prediction tools aim to improve decision-making regarding the prevention of lower urinary tract symptoms (LUTS) and other pelvic floor disorders after childbirth (PMID:29056536), de novo stress urinary incontinence and other patient-perceived outcomes after pelvic organ prolapse surgery, risk of transfusion during gynecologic surgery, and urinary outcomes after mid-urethral sling surgery (PMID: 26942362). He also has significant expertise in leading trans-disciplinary teams through NIH-funded multi-center research networks and international settings. As alternate-PI for the Cleveland Clinic site in the NICHD Pelvic Floor Disorders Network, he was principal investigator on the CAPABLe trial (PMID: 31320277), one of the largest multi-center trials for fecal incontinence studying anal exercises with biofeedback and loperamide for the treatment of fecal incontinence. He was the principal investigator of the E-OPTIMAL study (PMID: 29677302), describing the long-term follow up sacrospinous ligament fixation compared to uterosacral ligament suspension for apical vaginal prolapse. He was also primary author on research establishing the minimum important clinical difference for commonly used measures of fecal incontinence. Currently, he serves as co-PI in the NIDDK Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01DK097780-05) where he has been involved in studies in the development of Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) and LURN SI-10 questionnaires for men and women with LUTS. He is also the site-PI for the PREMIER trial (1R01HD105892): Patient-Centered Outcomes of Sacrocolpopexy versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse.
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