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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00270998 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Urinary Incontinence Mixed Stress and Urge Urinary Incontinence |
Behavioral: Pelvic muscle training and exercises Device: Intravaginal incontinence pessary Device: Both pessary and pelvic muscle exercises |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | ATLAS: Ambulatory Treatments for Leakage Associated With Stress, A Randomized Trial of Pelvic Muscle Exercise Versus Incontinence Pessary Versus Both for Women With Stress or Mixed Urinary Incontinence |
| Enrollment: | 450 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Pessary
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Device: Intravaginal incontinence pessary
Intravaginal incontinence pessary
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2: Experimental
Behavioral therapy
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Behavioral: Pelvic muscle training and exercises
Pelvic muscle training and exercises
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3: Experimental
Combination of pessary and behavioral therapy
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Device: Both pessary and pelvic muscle exercises
Intravaginal incontinence pessary and pelvic muscle training and exercises
|
Women commonly have symptoms of stress urinary incontinence (leakage with physical stress such as coughing or sneezing) and urinary urgency or urge incontinence (leakage associated with the overwhelming urge to urinate). Non-surgical treatment is usually offered as first-line therapy, such as pelvic muscle exercises ("Kegel" exercises) or pessary use. A pessary is a small ring that fits inside the vagina. Pelvic muscle training and exercises may help incontinence by increased awareness and strength of the muscles that are used in holding the urethra closed. Pessary use may help incontinence by providing more support to the bladder and urethra. Both treatments can be helpful in reducing or eliminating incontinence, but it is not known which treatment is better. The study will compare the level of improvement with pelvic muscle exercises, pessary use, and a combination of both exercises and pessary.
Women with stress or mixed urinary incontinence will be randomly assigned to 1 of 3 groups: (1) pelvic muscle training and exercises; (2) pessary use; and (3) both exercises and pessary. Women in the exercises groups will have 4 visits over 8 weeks with a specially trained therapist for pelvic muscle training and exercises. Women in the pessary group will be fitted with a pessary to be worn continuously. Assessments will include questionnaires, bladder diary, and physical examination. Follow-up evaluations occur at 3 months, 6 months (by telephone only), and 1 year after initial treatment.
Comparisons: The level of improvement after treatment will be compared in the 3 groups. In addition, women in the 3 groups will record the number of accidental leakage episodes by bladder diary; and the frequency of those episodes will be compared in the 3 groups. Other aspects of health, including health-related quality of life, will be compared in the 3 groups.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| University of California, San Diego Medical Center | |
| La Jolla, California, United States, 92037 | |
| United States, Illinois | |
| Loyola University | |
| Maywood, Illinois, United States, 60153 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Study Director: | Anne M Weber, MD, MS | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Principal Investigator: | Morton B Brown, PhD | Data Coordinating Center, University of Michigan |
More Information
| Responsible Party: | NICHD ( Susan Meikle, Project Scientist ) |
| Study ID Numbers: | PFDN 13 |
| Study First Received: | December 27, 2005 |
| Last Updated: | January 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00270998 |
| Health Authority: | United States: Federal Government |
|
Stress urinary incontinence |
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Signs and Symptoms Urinary Incontinence, Stress Urologic Diseases Urination Disorders |
Stress Urinary Incontinence Urinary Incontinence, Urge |
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Urological Manifestations Pathologic Processes |
