Trial record 8 of 18 for:    pelvic floor disorders | NICHD [Lead]

ATLAS: Ambulatory Treatments for Leakage Associated With Stress

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT00270998
First received: December 27, 2005
Last updated: September 27, 2013
Last verified: September 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • Questionnaire: Patient Global Impression of Improvement [ Time Frame: 3 and 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incontinent episodes by bladder diary [ Time Frame: 3 and 12 month ] [ Designated as safety issue: No ]
  • Incontinence-related quality of life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Change in pelvic muscle strength [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Expectation of treatment benefit [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pessary
Device: Intravaginal incontinence pessary
Intravaginal incontinence pessary
Experimental: 2
Behavioral therapy
Behavioral: Pelvic muscle training and exercises
Pelvic muscle training and exercises
Experimental: 3
Combination of pessary and behavioral therapy
Device: Both pessary and pelvic muscle exercises
Intravaginal incontinence pessary and pelvic muscle training and exercises

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Stress urinary incontinence or stress-predominant mixed urinary incontinence, with at least 2 episodes of stress incontinence on 7-day bladder diary and the number of stress incontinence episodes exceeding the number of urge incontinence episodes.
  • Urinary incontinence for at least three months.
  • Ambulatory adult women.
  • Stage 0-I-II pelvic organ prolapse.

Exclusion Criteria:

  • Continual urine leakage.
  • Pregnancy or planning pregnancy within 1 year.
  • Active urinary tract infection.
  • Urinary retention.
  • Currently on medication for incontinence.
  • Currently using a pessary.
  • Neurologic condition that affects bladder function.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270998

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
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
Investigators
Study Chair: Holly E Richter, PhD, MD University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT00270998     History of Changes
Other Study ID Numbers: PFDN 13
Study First Received: December 27, 2005
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Pelvic Floor Disorders Network:
Stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014