Clinical trial NCT00270998: ATLAS: Ambulatory Treatments for Leakage Associated With Stress
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Urinary Incontinence
Keywords: Stress urinary incontinence
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
First posted: 2005-12-29
Enrollment: 445
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: "Much Better" or "Very Much Better" on PGI-I at 3 Months
timeFrame: Outcome was measured at three months following randomization.
measure: No Bothersome Stress Incontinence Symptoms at 3 Months
timeFrame: Outcome was measured at three months following randomization.
Secondary outcomes:
measure: "Much Better" or "Very Much Better" on PGI-I at 12 Months
timeFrame: Outcome was measured at 12 months following randomization.
measure: No Bothersome Stress Incontinence Symptoms at 12 Months.
timeFrame: Outcome was measured at 12 months following randomization.
measure: 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months
timeFrame: Outcome was measured at three months following randomization.
measure: 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months
timeFrame: Outcome was measured at 12 months following randomization.
measure: Satisfaction With Treatment at 3 Months
timeFrame: Outcome was measured at three months following randomization.
measure: Satisfaction With Treatment at 12 Months
timeFrame: Outcome was measured at 12 months following randomization.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly E Richter, PhD, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.