Holly E Richter1, Kathryn L Burgio, Linda Brubaker, Ingrid E Nygaard, Wen Ye, Alison Weidner, Catherine S Bradley, Victoria L Handa, Diane Borello-France, Patricia S Goode, Halina Zyczynski, Emily S Lukacz, Joseph Schaffer, Matthew Barber, Susan Meikle, Cathie Spino. 1. From the University of Alabama at Birmingham, Birmingham, Alabama; Birmingham VA Medical Center, Birmingham, Alabama; Loyola University, Maywood, Illinois; University of Utah, Salt Lake City, Utah; University of Michigan, Ann Arbor, Michigan; Duke University, Durham, North Carolina; University of Iowa, Iowa City, Iowa; Johns Hopkins School of Medicine, Baltimore, Maryland; Duquesne University, Pittsburgh, Pennsylvania; Magee-Womens Hospital, Pittsburgh, Pennsylvania; University of California San Diego, San Diego, California; University of Texas Southwestern, Dallas, Texas; Cleveland Clinic, Cleveland, Ohio; and National Institutes of Health, Bethesda, Maryland.
Abstract
OBJECTIVE: 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. METHODS: This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach. RESULTS: At 3 months, 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 (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups. CONCLUSION: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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.
RCT Entities:
OBJECTIVE: 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. METHODS: This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach. RESULTS: At 3 months, 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 (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998.
Authors: Holly E Richter; Kathryn L Burgio; Patricia S Goode; Diane Borello-France; Catherine S Bradley; Linda Brubaker; Victoria L Handa; Paul M Fine; Anthony G Visco; Halina M Zyczynski; John T Wei; Anne M Weber Journal: Clin Trials Date: 2007 Impact factor: 2.486
Authors: Patricia S Goode; Kathryn L Burgio; Julie L Locher; David L Roth; Mary G Umlauf; Holly E Richter; R Edward Varner; L Keith Lloyd Journal: JAMA Date: 2003-07-16 Impact factor: 56.272
Authors: Yuko M Komesu; Loren H Ketai; Rebecca G Rogers; Steven C Eberhardt; Jennifer Pohl Journal: Am J Obstet Gynecol Date: 2008-03-20 Impact factor: 8.661
Authors: Matthew D Barber; Cathie Spino; Nancy K Janz; Linda Brubaker; Ingrid Nygaard; Charles W Nager; Thomas L Wheeler Journal: Am J Obstet Gynecol Date: 2009-05 Impact factor: 8.661
Authors: E J C Hay-Smith; K Bø; L C M Berghmans; H J M Hendriks; R A de Bie; E S C van Waalwijk van Doorn Journal: Cochrane Database Syst Rev Date: 2007-07-18
Authors: Mathieu Bettez; Le Mai Tu; Kevin Carlson; Jacques Corcos; Jerzy Gajewski; Martine Jolivet; Greg Bailly Journal: Can Urol Assoc J Date: 2012-10 Impact factor: 1.862
Authors: Victoria L Handa; Emily Whitcomb; Alison C Weidner; Ingrid Nygaard; Linda Brubaker; Catherine S Bradley; Marie Fidela R Paraiso; Joseph Schaffer; Halina M Zyczynski; Min Zhang; Holly E Richter Journal: Female Pelvic Med Reconstr Surg Date: 2011 Impact factor: 2.091
Authors: Joseph Schaffer; Charles W Nager; Fang Xiang; Diane Borello-France; Catherine S Bradley; Jennifer M Wu; Elizabeth Mueller; Peggy Norton; Marie Fidela R Paraiso; Halina Zyczynski; Holly E Richter Journal: Obstet Gynecol Date: 2012-07 Impact factor: 7.661