Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment
For some patients, oral medications (pills) and behavioral therapy do not help enough for very bothersome urgency urinary incontinence (for example, leaking of urine that happens along with an urge to urinate, but not enough time to get to the toilet). This can occur because the pills just do not work, or because the side effects are too bothersome to take. We describe this poor response or intolerance to commonly prescribed medications as refractory overactive bladder or urgency urinary incontinence.
The ROSETTA study is a formal comparison of two treatments for urge urinary incontinence.The ROSETTA study compares the use of Botox A® (onabotulinumtoxin A) with sacral neuromodulation (also called InterStim® therapy).
Since 1997, doctors have offered women with refractory urgency urinary incontinence a treatment called neuromodulation. Like a pacemaker for the heart, InterStim® uses mild electrical pulses to stimulate nerves going to the bladder. These electrical “messages” (neuromodulation) influence bladder function to help prevent urgency urinary incontinence. It is a reversible treatment, and is the only implantable neuromodulation system approved by the Federal Drug Administration (FDA) in the United States for the treatment of this condition. Botox has also been approved by the FDA in January 2013 for injection into the bladder in women with refractory urgency urinary incontinence. The injections are typically done in the office and take about 15 minutes.
Both Interstim® and Botox A® have been studied before, so we know that they are effective in the treatment of urge incontinence. This study will compare the two treatments to see whether one is better than the other at reducing urge incontinence episodes in women. Also, this study will look closely at the effects that these two treatments have on other bladder and pelvic floor symptoms.
Women in this study are being randomly assigned to receive either an injection of Botox A® into the bladder or the Interstim® device. All women are being asked to complete bladder symptom diaries and questionnaires, and to undergo examinations every 6 months for 2 years after treatment.
The study started in June 2012. We expect that enrollment of 380 women will occur over 2 years. The primary outcome, effectiveness of treatment 6 months after starting therapy will be analyzed in the spring of 2015, so look for an update at that time.
STUDY RESULTS:
Amundsen CL, Richter HE, Menefee S, Vasavada S, Rahn DD, Kenton K, Harvie HS, Wallace D, Meikle S. The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial. Contemporary clinical trials. 2014 Mar; 37(2): 272-83.
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Harvie HS, Amundsen CL, Neuwahl SJ, Honeycutt AA, Lukacz ES, Sung VW, Rogers RG, Ellington D, Ferrando CA, Chermansky CJ, Mazloomdoost D, Thomas S. Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial. J. Urol.. 2020 05; 203(5): 969-977.
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Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct; 316(13): 1366-1374.
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Amundsen CL, Richter HE, Wallace D, Pelvic Floor Disorders Network. OnabotulinumtoxinA vs Sacral Neuromodulation for Urgency Incontinence-Reply. JAMA. 2017 Feb; 317(5): 535-536.
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Richter HE, Amundsen CL, Erickson SW, Jelovsek JE, Komesu Y, Chermansky C, Harvie HS, Albo M, Myers D, Gregory WT, Wallace D, NICHD Pelvic Floor Disorders Network. Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence. The Journal of urology. 2017 10; 198(4): 890-896.
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Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D, Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. European urology. 2018 07; (): .
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Komesu YM, Amundsen CL, Richter HE, Erickson SW, Ackenbom MF, Andy UU, Sung VW, Albo M, Gregory WT, Paraiso MF, Wallace D, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications. American journal of obstetrics and gynecology. 2018 01; 218(1): 111.e1-111.e9.
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Andy UU, Amundsen CL, Honeycutt E, Markland AD, Dunivan G, Dyer KY, Korbly NB, Bradley M, Vasavada S, Mazloomdoost D, Thomas S, NICHD Pelvic Floor Disorders Network. Sacral Neuromodulation versus OnabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function. American journal of obstetrics and gynecology. 2019 Jun; (): .
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Read more about this study at clinicaltrials.gov.