THE ATLAS TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Although surgical treatment for stress urinary incontinence (SUI) has a high satisifaction rate, many women prefer non-surgical treatment. Two commonly-used modes of non-surgical treatment include pelvic muscle exercises and intravaginal continence pessaries (the latter refers to devices women wears in the vagina). Despite the common use of these two treatments, there is little information comparing their effectiveness. The hypotheses being tested with this study include that treatment with a pessary is more effective than pelvic muscle exercises for SUI (after 3 months of treatment) and that treatment with both of these therapies simultaneously is more effective than either treatment alone for SUI (after 3 months of treatment). To test these hypotheses, women will be randomized to either intravaginal continence pessary, pelvic muscle exercises, or combination for 12 months. Response will be assessed by Global Improvement questionnaire and other validated questionnaire measures. This will provide important information in describing and comparing treatment success and subject satisfaction with these non-surgical treatments for SUI.