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ATLAS: Ambulatory Treatments for Leakage Associated With Stress

NCT00270998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2018-05-30

Study results available
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Summary

Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises and pessary use. Pelvic muscle exercises (often known as "Kegel" exercises) train and strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence. Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better, or if a combination of the two treatments at the same time is best. This study will determine whether pelvic muscle training and exercises, pessary use, or a combination of both exercises and pessary is most effective at improving incontinence in women. The study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.

Conditions

Interventions

BEHAVIORAL

Behavioral Therapy

Pelvic muscle training and exercises

DEVICE

Intravaginal Pessary

Intravaginal pessary

DEVICE

Pessary combined with behavioral therapy

Intravaginal pessary and behavioral therapy

Sponsors & Collaborators

  • NICHD Pelvic Floor Disorders Network

    lead NETWORK

Principal Investigators

  • Holly E Richter, PhD, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00270998 on ClinicalTrials.gov