ATLAS: Ambulatory Treatments for Leakage Associated With Stress

NCT00270998 | Completed Phase 3 Results DMC

• 1 other identifier: PFDN 13
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 8

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Keywords

Stress urinary incontinence

Outcome Measures

Primary Outcomes (2)

• "Much Better" or "Very Much Better" on PGI-I at 3 Months

  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.

  Outcome was measured at three months following randomization.

• No Bothersome Stress Incontinence Symptoms at 3 Months

  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.

  Outcome was measured at three months following randomization.

Secondary Outcomes (6)

• "Much Better" or "Very Much Better" on PGI-I at 12 Months

  Outcome was measured at 12 months following randomization.

• No Bothersome Stress Incontinence Symptoms at 12 Months.

  Outcome was measured at 12 months following randomization.

• 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months

  Outcome was measured at three months following randomization.

• 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months

  Outcome was measured at 12 months following randomization.

• Satisfaction With Treatment at 3 Months

  Outcome was measured at three months following randomization.

Study Arms (3)

Intravaginal Pessary

EXPERIMENTAL

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

Device: Intravaginal Pessary

Behavioral Therapy

EXPERIMENTAL

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

Pessary combined with behavioral therapy

EXPERIMENTAL

Combination of the explanations above.

Device: Pessary combined with behavioral therapy

Interventions

Behavioral Therapy BEHAVIORAL

Pelvic muscle training and exercises

Behavioral Therapy

Intravaginal Pessary DEVICE

Intravaginal pessary

Intravaginal Pessary

Pessary combined with behavioral therapy DEVICE

Intravaginal pessary and behavioral therapy

Pessary combined with behavioral therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

University of California, San Diego Medical Center

La Jolla, California, 92037, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (7)

• 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.

  PMID: 17327249 BACKGROUND

• 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.

  PMID: 20177294 RESULT

• 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.

  PMID: 23431210 DERIVED

• 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.

  PMID: 22914396 DERIVED

• 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.

  PMID: 22453323 DERIVED

• 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.

  PMID: 21344495 DERIVED

• 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.

  PMID: 19375574 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• Holly E Richter, PhD, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 29, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 30, 2018
• Results First Posted: August 10, 2017

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

US (8)