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Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.

Publication ,  Journal Article
Richter, HE; Burgio, KL; Brubaker, L; Nygaard, IE; Ye, W; Weidner, A; Bradley, CS; Handa, VL; Borello-France, D; Goode, PS; Zyczynski, H ...
Published in: Obstet Gynecol
March 2010

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.

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Published In

Obstet Gynecol

DOI

EISSN

1873-233X

Publication Date

March 2010

Volume

115

Issue

3

Start / End Page

609 / 617

Location

United States

Related Subject Headings

  • Urinary Incontinence, Stress
  • Pessaries
  • Patient Satisfaction
  • Obstetrics & Reproductive Medicine
  • Middle Aged
  • Intention to Treat Analysis
  • Humans
  • Follow-Up Studies
  • Female
  • Behavior Therapy
 

Citation

APA
Chicago
ICMJE
MLA
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Richter, H. E., Burgio, K. L., Brubaker, L., Nygaard, I. E., Ye, W., Weidner, A., … Pelvic Floor Disorders Network, . (2010). Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol, 115(3), 609–617. https://doi.org/10.1097/AOG.0b013e3181d055d4
Richter, Holly E., Kathryn L. Burgio, Linda Brubaker, Ingrid E. Nygaard, Wen Ye, Alison Weidner, Catherine S. Bradley, et al. “Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.Obstet Gynecol 115, no. 3 (March 2010): 609–17. https://doi.org/10.1097/AOG.0b013e3181d055d4.
Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, et al. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609–17.
Richter, Holly E., et al. “Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial.Obstet Gynecol, vol. 115, no. 3, Mar. 2010, pp. 609–17. Pubmed, doi:10.1097/AOG.0b013e3181d055d4.
Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C, Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609–617.

Published In

Obstet Gynecol

DOI

EISSN

1873-233X

Publication Date

March 2010

Volume

115

Issue

3

Start / End Page

609 / 617

Location

United States

Related Subject Headings

  • Urinary Incontinence, Stress
  • Pessaries
  • Patient Satisfaction
  • Obstetrics & Reproductive Medicine
  • Middle Aged
  • Intention to Treat Analysis
  • Humans
  • Follow-Up Studies
  • Female
  • Behavior Therapy