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

Summary

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®.

Conditions

• Urinary Incontinence, Urge

Interventions

DEVICE

InterStim® device

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.

DRUG

Botox® injection

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.

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Brown University

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• RTI International

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• 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

• 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)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations