NCT01502956|CompletedPhase 3ResultsDMC
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
ROSETTA
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Sponsor study identifier
Secondary identifiers
NIH
interventional
386
1 country
9
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)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®.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2011
Actual (reported)January 2, 2012
Actual (reported)February 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2016
Actual (reported)July 2016
Actual (reported)March 8, 2018
Actual (reported)Number of Urge Urinary Incontinence (UUI) Episodes
The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.
6 Months
Number of Participants With Improvement of Bladder Function and Urinary Leakage
6 Months
Change in Overactive Bladder
6 Months
Urinary Frequency and Nocturia
6 Months
Severity of Urge Incontinence Symptoms
6 Months
Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
6 months
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be defined as a ≥50% improvement in the mean number of UUIE/day on a minimum 3 day bladder diary, completed during the 7-14 days following the first stage lead placement (FSLP). Subjects with a ≥ 50% improvement mean number of UUIE/day will be eligible to proceed with implantation of the implantable pulse generator (IPG). Subjects will then be followed monthly to determine the response to therapy.
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, 35249-7333, United States
University of California, San Diego, Women's Pelvic Medicine Center
La Jolla, California, 92037, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131-0001, United States
Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 277707, United States
Cleveland Clinic, Obstretric and Gynecology and Women Health Institute
Cleveland, Ohio, 44194, United States
Oregon Health and Science University, Kohler Pavilion
Portland, Oregon, 97239, United States
Hendrickson WK, Amundsen CL, Rahn DD, Meyer I, Bradley MS, Smith AL, Myers DL, Jelovsek JE, Lukacz ES. Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence. Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):140-146. doi: 10.1097/SPV.0000000000001020.
Richter HE, Jelovsek JE, Iyer P, Rogers RG, Meyer I, Newman DK, Bradley MS, Harm-Ernandes I, Dyer KY, Wohlrab K, Mazloomdoost D, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women's Health. Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence. Am J Gastroenterol. 2020 Jan;115(1):115-127. doi: 10.14309/ajg.0000000000000482.
Cindy Amundsen, MD
Duke University
Holly Richter, PhD, MD
University of Alabama at Birmingham
Shawn A. Menefee, MD
Kaiser Permanente, San Diego, CA
Sandip Vasada, MD
The Cleveland Clinic
386 participants (actual enrollment reported by the registry).
First Submitted
December 27, 2011
First Posted
January 2, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy
Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univesity of Pittsburgh, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903, United States
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. Am J Obstet Gynecol. 2019 Nov;221(5):513.e1-513.e15. doi: 10.1016/j.ajog.2019.06.018. Epub 2019 Jun 15.
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. Am J Obstet Gynecol. 2018 Jan;218(1):111.e1-111.e9. doi: 10.1016/j.ajog.2017.10.006. Epub 2017 Oct 12.
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. Contemp Clin Trials. 2014 Mar;37(2):272-83. doi: 10.1016/j.cct.2014.01.009. Epub 2014 Jan 30.
Deborah L. Myers, MD
Brown/Women and Infants Hospital of Rhode Island
Yoko Kumesu, MD
University of New Mexico
Lily Arya, MD
University of Pennsylvania
Jerry Lowder, MD
University of Pittsburgh
W. Thomas Gregory, MD
Oregon Health and Science University
Dennis Wallace, PhD
RTI International
Susan Meikle, MD, MSPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
May 2, 2018
Results First Posted
March 8, 2018
Record last verified: 2018-04
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