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ATLAS: Ambulatory Treatments for Leakage Associated With Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270998
First Posted: December 29, 2005
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dwallace, NICHD Pelvic Floor Disorders Network
  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 Urinary Incontinence Behavioral: Behavioral Therapy Device: Intravaginal Pessary Device: Pessary combined with behavioral therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 dwallace, NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • "Much Better" or "Very Much Better" on PGI-I at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." Participants were considered a success if they responded "much better" or "very much better," or a failure if they responded otherwise.

  • No Bothersome Stress Incontinence Symptoms at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participants answer either "no" or "yes" with a bother component of "not at all" or "somewhat" to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.


Secondary Outcome Measures:
  • "Much Better" or "Very Much Better" on PGI-I at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." Participants were considered a success if they responded "much better" or "very much better," or a failure if they responded otherwise.

  • No Bothersome Stress Incontinence Symptoms at 12 Months. [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participants answer either "no" or "yes" with a bother component of "not at all" or "somewhat" to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.

  • 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.

  • 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.

  • Satisfaction With Treatment at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.

  • Satisfaction With Treatment at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.


Enrollment: 445
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: Intravaginal Pessary
Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra.
Device: Intravaginal Pessary
Intravaginal pessary
Experimental: Behavioral Therapy
Pelvic floor muscle training and exercise which includes strong contraction of the pelvic floor muscles to prevent incontinence by occluding the urethra and regular practice can improve pelvic muscle support.
Behavioral: Behavioral Therapy
Pelvic muscle training and exercises
Experimental: Pessary combined with behavioral therapy
Combination of the explanations above.
Device: Pessary combined with behavioral therapy
Intravaginal pessary and behavioral therapy

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: dwallace, Project Director, NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT00270998     History of Changes
Other Study ID Numbers: PFDN 13
First Submitted: December 27, 2005
First Posted: December 29, 2005
Results First Submitted: April 18, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 20, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders