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Mixed Incontinence: Medical Or Surgical Approach?

NCT00803270 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-05-10

Study results available
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Summary

The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Conditions

Interventions

DRUG

Non-Surgical Intervention

Both oral urge incontinence medication and behavioral treatment

PROCEDURE

Surgical

Initial surgical (stress incontinence surgery) treatment approach.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • The University of Texas at San Antonio

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Beaumont Hospital

    collaborator OTHER

  • Loyola University

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Ann Gormley, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00803270 on ClinicalTrials.gov