Alison C Weidner1, Matthew D Barber2, Alayne Markland3, David D Rahn4, Yvonne Hsu5, Elizabeth R Mueller6, Sharon Jakus-Waldman7, Keisha Y Dyer8, Lauren Klein Warren9, Marie G Gantz9, Susie Meikle10. 1. Department of Obstetrics and Gynecology, Duke University Medical Center, 5324 McFarland Dr, Suite 310, Durham, NC 27707 (USA). 2. Department of Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio. 3. Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, Alabama. 4. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas. 5. Department of Obstetrics and Gynecology, University of Utah Medical Center, Salt Lake City, Utah. 6. Department of Urology, Loyola University Medical Center Stritch School of Medicine, Chicago, Illinois. 7. Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, Downey, California. 8. Department of Obstetrics and Gynecology, Kaiser Permanente San Diego Medical Center, San Diego, California. 9. Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, North Carolina. 10. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Gynecologic Health and Disease Branch, Bethesda, Maryland.
Abstract
BACKGROUND: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. OBJECTIVE: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). DESIGN: This study is a secondary report of a 2 × 2 factorial randomized controlled trial. SETTING: This study was a multicenter trial. PARTICIPANTS: Participants were adult women with stage 2-4 POP and SUI. INTERVENTION: Perioperative BPMT versus usual care and sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) were provided. MEASUREMENTS: Participants undergoing transvaginal surgery (SSLF or ULS for POP and a midurethral sling for SUI) received usual care or five perioperative BPMT visits. The primary outcome was change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII), and Brink scores. RESULTS: The 374 participants were randomized to BPMT (n = 186) and usual care (n = 188). Outcomes were available for 137 (74%) of BPMT participants and 146 (78%) of the usual care participants at 24 months. There were no statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, or body image scale measures. LIMITATIONS: The clinicians providing BPMT had variable expertise. Findings might not apply to vaginal prolapse procedures without slings or abdominal apical prolapse procedures. CONCLUSIONS: Perioperative BPMT performed as an adjunct to vaginal surgery for POP and SUI provided no additional improvement in QOL or sexual function compared with usual care.
BACKGROUND: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. OBJECTIVE: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). DESIGN: This study is a secondary report of a 2 × 2 factorial randomized controlled trial. SETTING: This study was a multicenter trial. PARTICIPANTS: Participants were adult women with stage 2-4 POP and SUI. INTERVENTION: Perioperative BPMT versus usual care and sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) were provided. MEASUREMENTS: Participants undergoing transvaginal surgery (SSLF or ULS for POP and a midurethral sling for SUI) received usual care or five perioperative BPMT visits. The primary outcome was change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII), and Brink scores. RESULTS: The 374 participants were randomized to BPMT (n = 186) and usual care (n = 188). Outcomes were available for 137 (74%) of BPMT participants and 146 (78%) of the usual care participants at 24 months. There were no statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, or body image scale measures. LIMITATIONS: The clinicians providing BPMT had variable expertise. Findings might not apply to vaginal prolapse procedures without slings or abdominal apical prolapse procedures. CONCLUSIONS: Perioperative BPMT performed as an adjunct to vaginal surgery for POP and SUI provided no additional improvement in QOL or sexual function compared with usual care.
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