ATLAS

Ambulatory Treatments for Leakage Associated with Stress. Pessary versus Pelvic Floor Muscle Therapy versus Combined Therapy: A randomized Controlled Trial of Non-Surgical Treatment for Stress Urinary Incontinence

The Ambulatory Treatments for Leakage Associated with Stress Incontinence (ATLAS) Trial was a study comparing 3 non-surgical approaches to the management of stress urinary incontinence, which is involuntary urine leakage with activities such as running, coughing and sneezing. The treatments included behavioral therapy, which is the strengthening of the pelvic muscles and strategies for use of these muscles and the use of a pessary, which is a device placed into the vagina to help support the bladder neck. The third treatment approach was combination behavioral therapy and pessary use. The primary outcome time-point was 3 months after randomization and measured the patient's impression of improvement and improvement of stress incontinence symptoms, both validated measures used to evaluate women undergoing treatment for incontinence. Compared to the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared to 33%, p=0.006) and scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the patient global impression of improvement (no significant difference, p=0.10). Significantly more women in the behavioral group were satisfied with treatment as compared to the pessary group (75% compared with 63%, respectively, p=0.02). Combination therapy was not significantly different from single-modality therapy. There were no differences on any outcome measures by 12 months and greater than half of all patients were satisfied in all treatment groups.


STUDY RESULTS SUMMARY

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Richter HE, et al. Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial. Clin Trials. 2007.

Brubaker L, et al. Quantification of vaginal support: are continuous summary scores better than POPQ stage? Am J Obstet Gynecol. 2010 Nov.

Barber MD, et al. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr.

ClinicalTrials.gov

ClinicalTrials.Gov ID: NCT00270998