ROSETTA

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.

STUDY RESULTS SUMMARY

Gill BC, et al. Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial. J Urol. 2023 Aug.

Hendrickson WK, et al. Predicting outcomes after intradetrusor onabotulinumtoxina for non-neurogenic urgency incontinence in women. Neurourol Urodyn. 2022 Jan.

Harvie HS, et al. Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial. J Urol. 2020 May.

Andy UU, et al. Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function. Am J Obstet Gynecol. 2019 Nov.

Amundsen CL, et al. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul.

Komesu YM, et al. Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications. Am J Obstet Gynecol. 2018 Jan.

Richter HE, et al. Characteristics Associated with Treatment Response and Satisfaction in Women Undergoing OnabotulinumtoxinA and Sacral Neuromodulation for Refractory Urgency Urinary Incontinence. J Urol. 2017 Oct.

Amundsen CL, et al. OnabotulinumtoxinA vs Sacral Neuromodulation for Urgency Incontinence-Reply. JAMA. 2017 Feb 7.

Amundsen CL, et al. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4.

Amundsen CL, et al. The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial. Contemp Clin Trials. 2014 Mar.

ClinicalTrials.gov

ClinicalTrials.Gov ID: NCT01502956