Clinical trialNCT01502956CompletedPhase 3Interventional

Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)

SponsorNICHD Pelvic Floor Disorders NetworkEnrollment386Urinary Incontinence, Urge

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study will evaluate select technical attributes of the interventions as well as the effect of these two interventions on other lower urinary tract and pelvic floor symptoms. Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary incontinence episodes over the 6-month follow-up period as compared to Botox A® injection. A supplemental study investigates whether biological markers including those related to inflammation and connective tissue remodeling change following treatments with Botox A® and Interstim®.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Cindy Amundsen, MD
Duke University
Study Chair
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Deborah L. Myers, MD
Brown/Women and Infants Hospital of Rhode Island
Principal Investigator
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Dennis Wallace, PhD
RTI International
Principal Investigator
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Holly Richter, PhD, MD
University of Alabama at Birmingham
Principal Investigator
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Jerry Lowder, MD
University of Pittsburgh
Principal Investigator
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Lily Arya, MD
University of Pennsylvania
Principal Investigator
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Sandip Vasada, MD
The Cleveland Clinic
Principal Investigator
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Shawn A. Menefee, MD
Kaiser Permanente, San Diego, CA
Principal Investigator
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Susan Meikle, MD, MSPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator
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W. Thomas Gregory, MD
Oregon Health and Science University
Principal Investigator
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Yoko Kumesu, MD
University of New Mexico
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States
University of California, San Diego, Women'S Pelvic Medicine Center
La Jolla, California, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
Cleveland Clinic, Obstretric and Gynecology and Women Health Institute
Cleveland, Ohio, United States
Oregon Health and Science University, Kohler Pavilion
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Univesity of Pittsburgh, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island, Center for Women'S Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Botox® injection

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Feb 2012
Primary completion: 31 Jul 2016
Completion: 31 Jul 2016
Last update posted: 2 May 2018
Registered enrollment: 386
Registry id: NCT01502956

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.