Combined Treatment for Mixed Incontinence

Summary

The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population.

A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.

Conditions

• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Interventions

PROCEDURE

Miduretheral Sling

MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).

OTHER

Miduretheral Sling with behavioral/pelvic floor therapy

MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

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

  collaborator NIH

• RTI International

  collaborator OTHER

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Vivian W. Sung · Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery

• Dennis Wallace · RTI International

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-28

Primary Completion

2017-08-09

Completion

2017-09-29

Countries

• United States

Study Locations