- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270998
ATLAS: Ambulatory Treatments for Leakage Associated With Stress
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35249
- University Of Alabama
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California
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La Jolla, California, United States, 92037
- University of California, San Diego Medical Center
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intravaginal Pessary
Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra.
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Intravaginal pessary
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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.
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Pelvic muscle training and exercises
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EXPERIMENTAL: Pessary combined with behavioral therapy
Combination of the explanations above.
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Intravaginal pessary and behavioral therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Much Better" or "Very Much Better" on PGI-I at 3 Months
Time Frame: Outcome was measured at three months following randomization.
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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.
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Outcome was measured at three months following randomization.
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No Bothersome Stress Incontinence Symptoms at 3 Months
Time Frame: Outcome was measured at three months following randomization.
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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.
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Outcome was measured at three months following randomization.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Much Better" or "Very Much Better" on PGI-I at 12 Months
Time Frame: Outcome was measured at 12 months following randomization.
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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.
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Outcome was measured at 12 months following randomization.
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No Bothersome Stress Incontinence Symptoms at 12 Months.
Time Frame: Outcome was measured at 12 months following randomization.
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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.
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Outcome was measured at 12 months following randomization.
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75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months
Time Frame: Outcome was measured at three months following randomization.
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Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
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Outcome was measured at three months following randomization.
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75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months
Time Frame: Outcome was measured at 12 months following randomization.
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Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
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Outcome was measured at 12 months following randomization.
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Satisfaction With Treatment at 3 Months
Time Frame: Outcome was measured at three months following randomization.
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Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
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Outcome was measured at three months following randomization.
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Satisfaction With Treatment at 12 Months
Time Frame: Outcome was measured at 12 months following randomization.
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Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
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Outcome was measured at 12 months following randomization.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Richter HE, Burgio KL, Goode PS, Borello-France D, Bradley CS, Brubaker L, Handa VL, Fine PM, Visco AG, Zyczynski HM, Wei JT, Weber AM; Pelvic Foor Desorders Network. Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial. Clin Trials. 2007;4(1):92-101. doi: 10.1177/1740774506075237.
- Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4.
- Borello-France D, Burgio KL, Goode PS, Ye W, Weidner AC, Lukacz ES, Jelovsek JE, Bradley CS, Schaffer J, Hsu Y, Kenton K, Spino C; Pelvic Floor Disorders Network. Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors. Phys Ther. 2013 Jun;93(6):757-73. doi: 10.2522/ptj.20120072. Epub 2013 Feb 21.
- Schaffer J, Nager CW, Xiang F, Borello-France D, Bradley CS, Wu JM, Mueller E, Norton P, Paraiso MF, Zyczynski H, Richter HE. Predictors of success and satisfaction of nonsurgical therapy for stress urinary incontinence. Obstet Gynecol. 2012 Jul;120(1):91-7. doi: 10.1097/AOG.0b013e31825a6de7.
- Kenton K, Barber M, Wang L, Hsu Y, Rahn D, Whitcomb E, Amundsen C, Bradley CS, Zyczynski H, Richter HE; Pelvic Floor Disorders Network. Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):118-21. doi: 10.1097/SPV.0b013e31824a021d.
- Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.
- Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, Wheeler TL; Pelvic Floor Disorders Network. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009 May;200(5):580.e1-7. doi: 10.1016/j.ajog.2009.02.007.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFDN 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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