To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy.
Multi-site, randomized clinical trial (“Ambulatory Treatments for Leakage Associated with Stress Incontinence” (ATLAS)) randomized 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3months, were Patient Global Impression of Improvement (PGI-I) and the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI). A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcomes measures were repeated at 6 and 12 months. Primary analyses used intention-to-treat approach.
At 3 months, 40% of the pessary group and 49% of the behavioral group were “much better” or “very much better” on PGI-I (p=0.09). Compared to the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% vs. 33%, p=0.006) and treatment satisfaction (75% vs. 63%, p=0.02). Combination therapy was significantly better than pessary on PGI-I (53%, p=0.02) and PFDI (44%, p=0.05), but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to12 months on any measure, and patient satisfaction remained above 50% for all treatment groups.
Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.