ATLAS: Ambulatory Treatments for Leakage Associated With Stress

• ClinicalTrials.gov Identifier: NCT00270998
• Recruitment Status: Completed
• First Posted: December 29, 2005
• Results First Posted: August 10, 2017
• Last Update Posted: May 30, 2018
• Sponsor: NICHD Pelvic Floor Disorders Network
• Information provided by (Responsible Party): NICHD Pelvic Floor Disorders Network

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence; Urinary Incontinence	Behavioral: Behavioral Therapy; Device: Intravaginal Pessary; Device: Pessary combined with behavioral therapy	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 445 participants
• 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
• Study Start Date: June 2005
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

1. "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.
2. 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 :

1. "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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• 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

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:

Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network 

Publications of Results:

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.

Other 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.

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

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.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT00270998
• Other Study ID Numbers: PFDN 13
• First Posted: December 29, 2005
• Results First Posted: August 10, 2017
• Last Update Posted: May 30, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by 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; Behavioral Symptoms; Elimination Disorders; Mental Disorders