ATLAS: Ambulatory Treatments for Leakage Associated With Stress

NCT ID: NCT00270998

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

Pelvic muscle training and exercises

Pessary combined with behavioral therapy

Combination of the explanations above.

Group Type: EXPERIMENTAL

Pessary combined with behavioral therapy

Intervention Type: DEVICE

Intravaginal pessary and behavioral therapy

Intravaginal Pessary

Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra.

Group Type: EXPERIMENTAL

Intravaginal Pessary

Intervention Type: DEVICE

Intravaginal pessary

Interventions

Behavioral Therapy

Pelvic muscle training and exercises

Intervention Type: BEHAVIORAL

Intravaginal Pessary

Intravaginal pessary

Intervention Type: DEVICE

Pessary combined with behavioral therapy

Intravaginal pessary and behavioral therapy

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NICHD Pelvic Floor Disorders Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly E Richter, PhD, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama

Birmingham, Alabama, United States

University of California, San Diego Medical Center

La Jolla, California, United States

Loyola University

Maywood, Illinois, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17327249 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20177294 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23431210 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22914396 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22453323 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21344495 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19375574 (View on PubMed)

Related Links

http://www.nichd.nih.gov

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

Other Identifiers

PFDN 13

Identifier Type: -

Identifier Source: org_study_id