Continence pessary compared with behavioral therapy or combined therapy for stress incontinence

A randomized controlled trial

Holly E. Richter, 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

Research output: Contribution to journalArticle

79 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)609-617
Number of pages9
JournalObstetrics and Gynecology
Volume115
Issue number3
DOIs
StatePublished - Mar 2010

Fingerprint

Pessaries
Randomized Controlled Trials
Therapeutics
Pelvic Floor
Patient Satisfaction
Outcome Assessment (Health Care)
Equipment and Supplies
Intention to Treat Analysis

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Continence pessary compared with behavioral therapy or combined therapy for stress incontinence : A randomized controlled trial. / Richter, Holly E.; Burgio, Kathryn L.; Brubaker, Linda; Nygaard, Ingrid E.; Ye, Wen; Weidner, Alison; Bradley, Catherine S.; Handa, Victoria L.; Borello-France, Diane; Goode, Patricia S.; Zyczynski, Halina; Lukacz, Emily S.; Schaffer, Joseph; Barber, Matthew; Meikle, Susan; Spino, Cathie.

In: Obstetrics and Gynecology, Vol. 115, No. 3, 03.2010, p. 609-617.

Research output: Contribution to journalArticle

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 2010, 'Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: A randomized controlled trial', Obstetrics and Gynecology, vol. 115, no. 3, pp. 609-617. https://doi.org/10.1097/AOG.0b013e3181d055d4
Richter, Holly E. ; Burgio, Kathryn L. ; Brubaker, Linda ; Nygaard, Ingrid E. ; Ye, Wen ; Weidner, Alison ; Bradley, Catherine S. ; Handa, Victoria L. ; Borello-France, Diane ; Goode, Patricia S. ; Zyczynski, Halina ; Lukacz, Emily S. ; Schaffer, Joseph ; Barber, Matthew ; Meikle, Susan ; Spino, Cathie. / Continence pessary compared with behavioral therapy or combined therapy for stress incontinence : A randomized controlled trial. In: Obstetrics and Gynecology. 2010 ; Vol. 115, No. 3. pp. 609-617.
@article{7cfc0f8516ad4ba9b6a845a9aceebae3,
title = "Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: A randomized controlled trial",
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.",
author = "Richter, {Holly E.} and Burgio, {Kathryn L.} and Linda Brubaker and Nygaard, {Ingrid E.} and Wen Ye and Alison Weidner and Bradley, {Catherine S.} and Handa, {Victoria L.} and Diane Borello-France and Goode, {Patricia S.} and Halina Zyczynski and Lukacz, {Emily S.} and Joseph Schaffer and Matthew Barber and Susan Meikle and Cathie Spino",
year = "2010",
month = "3",
doi = "10.1097/AOG.0b013e3181d055d4",
language = "English (US)",
volume = "115",
pages = "609--617",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Continence pessary compared with behavioral therapy or combined therapy for stress incontinence

T2 - A randomized controlled trial

AU - Richter, Holly E.

AU - Burgio, Kathryn L.

AU - Brubaker, Linda

AU - Nygaard, Ingrid E.

AU - Ye, Wen

AU - Weidner, Alison

AU - Bradley, Catherine S.

AU - Handa, Victoria L.

AU - Borello-France, Diane

AU - Goode, Patricia S.

AU - Zyczynski, Halina

AU - Lukacz, Emily S.

AU - Schaffer, Joseph

AU - Barber, Matthew

AU - Meikle, Susan

AU - Spino, Cathie

PY - 2010/3

Y1 - 2010/3

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=77649146667&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77649146667&partnerID=8YFLogxK

U2 - 10.1097/AOG.0b013e3181d055d4

DO - 10.1097/AOG.0b013e3181d055d4

M3 - Article

VL - 115

SP - 609

EP - 617

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 3

ER -