Phase 3
Completed N=445
ATLAS: Ambulatory Treatments for Leakage Associated With Stress
Source: ClinicalTrials.gov NCT00270998 ↗Enrolled (actual)
445
Serious AEs
3.8%
Results posted
Aug 2017
Primary outcomePrimary: "Much Better" or "Very Much Better" on PGI-I at 3 Months — 80; 72; 59 Participants — p=<0.0492
◆ Published Evidence
Highly cited
148citations · ~9 / year
Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.
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.
Linked Publications (5)
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Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.
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Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ).
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Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors.
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Predictors of success and satisfaction of nonsurgical therapy for stress urinary incontinence.
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Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY "Much Better" or "Very Much Better" on PGI-I at 3 Months |
80; 72; 59 | <0.0492 sig |
| PRIMARY No Bothersome Stress Incontinence Symptoms at 3 Months |
66; 71; 49 | 0.006 sig |
| SECONDARY "Much Better" or "Very Much Better" on PGI-I at 12 Months |
49; 48; 47 | <0.0492 sig |
| SECONDARY No Bothersome Stress Incontinence Symptoms at 12 Months. |
49; 59; 52 | <0.0492 sig |
| SECONDARY 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months |
80; 68; 69 | <0.0492 sig |
| SECONDARY 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months |
52; 54; 51 | <0.0492 sig |
| SECONDARY Satisfaction With Treatment at 3 Months |
118; 110; 94 | 0.03 sig |
| SECONDARY Satisfaction With Treatment at 12 Months |
81; 79; 75 | <0.0492 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00270998) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.