ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Phase 3

Completed

Conditions: Urinary Incontinence
Stress Urinary Incontinence

Interventions: Device: Intravaginal Pessary
Device: Pessary combined with behavioral therapy
Behavioral: Behavioral Therapy

Registration Number: NCT00270998

Lead Sponsor: NICHD Pelvic Floor Disorders Network

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 445

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravaginal Pessary	Intravaginal Pessary	Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra.
Pessary combined with behavioral therapy	Pessary combined with behavioral therapy	Combination of the explanations above.
Behavioral Therapy	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.

Primary Outcome Measures

Name	Time	Method
No Bothersome Stress Incontinence Symptoms at 3 Months	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.
"Much Better" or "Very Much Better" on PGI-I at 3 Months	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.

Secondary Outcome Measures

Name	Time	Method
"Much Better" or "Very Much Better" on PGI-I at 12 Months	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.
No Bothersome Stress Incontinence Symptoms at 12 Months.	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.
Satisfaction With Treatment at 3 Months	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.
75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months	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.
75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months	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.
Satisfaction With Treatment at 12 Months	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.

Trial Locations

Locations (8): Duke University
🇺🇸
Durham, North Carolina, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Loyola University
🇺🇸
Maywood, Illinois, United States
University of California, San Diego Medical Center
🇺🇸
La Jolla, California, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
University of Alabama
🇺🇸
Birmingham, Alabama, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
University of Texas Southwestern
🇺🇸
Dallas, Texas, United States