ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress Urinary Incontinence, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Behavioral Therapy
* Device: Intravaginal Pessary
* Device: Pessary combined with behavioral therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravaginal Pessary<br>Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra. | Device: Intravaginal Pessary<br>* Intravaginal pessary<br>|
| Experimental: Behavioral Therapy<br>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<br>* Pelvic muscle training and exercises<br>|
| Experimental: Pessary combined with behavioral therapy<br>Combination of the explanations above. | Device: Pessary combined with behavioral therapy<br>* Intravaginal pessary and behavioral therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Much Better or Very Much Better on PGI-I at 12 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 12 months following randomization. | 
| No Bothersome Stress Incontinence Symptoms at 12 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 12 months following randomization. | 
| 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. | Outcome was measured at three months following randomization. | 
| 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. | Outcome was measured at 12 months following randomization. | 
| Satisfaction With Treatment at 3 Months | Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | Outcome was measured at three months following randomization. | 
| Satisfaction With Treatment at 12 Months | Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | Outcome was measured at 12 months following randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence