Thaiana B Duarte1, Kari Bø2, Luiz Gustavo O Brito3, Sabrina M Bueno1, Thays Mr Barcelos1, Marília Ap Bonacin1, Cristine Hj Ferreira4. 1. Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil. 2. Department of Sports Medicine, Norwegian School of Sport Sciences and Department of Obstetrics and Gynecology, University Hospital, Lørenskog, Norway. 3. Department of Gynecology and Obstetrics, School of Medical Sciences, University of Campinas, Campinas, Brazil. 4. Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil. Electronic address: cristine@fmrp.usp.br.
Abstract
QUESTION: In women undergoing surgery for pelvic organ prolapse (POP), what is the average effect of the addition of perioperative pelvic floor muscle training on pelvic organ prolapse symptoms, pelvic floor muscle strength, quality of life, sexual function and perceived improvement after surgery? DESIGN: Randomised controlled trial with concealed allocation, blinded assessors, and intention-to-treat analysis. PARTICIPANTS: Ninety-six women with an indication for POP surgery. INTERVENTION: The experimental group received a 9-week pelvic floor muscle training protocol with four sessions before the surgery and seven sessions after the surgery. The control group received surgery only. OUTCOME MEASURES: Symptoms were assessed using the Pelvic Floor Distress Inventory (PFDI-20), which is scored from 0 'unaffected' to 300 'worst affected'. Secondary outcomes were assessed using vaginal manometry, validated questionnaires and Patient Global Impression of Improvement, which is scored from 1 'very much better' to 7 'very much worse'. All participants were evaluated 15 days before surgery, and at Days 40 and 90 after surgery. RESULTS: There was no substantial difference in POP symptoms between the experimental and control groups at Day 40 (31 (SD 24) versus 38 (SD 42), adjusted mean difference -6, 95% CI -25 to 13) or Day 90 (27 (SD 27) versus 33 (SD 33), adjusted mean difference -4, 95% CI -23 to 14). The experimental group perceived marginally greater global improvement than the control group; mean difference -0.4 (95% CI -0.8 to -0.1) at Day 90. However, the estimated effect of additional perioperative pelvic floor muscle training was estimated to be not beneficial enough to be considered worthwhile for any other secondary outcomes. CONCLUSION: In women undergoing POP surgery, additional perioperative pelvic floor muscle training had negligibly small effects on POP symptoms, pelvic floor muscle strength, quality of life or sexual function. TRIAL REGISTRATION: ReBEC, RBR-29kgz5.
RCT Entities:
QUESTION: In women undergoing surgery for pelvic organ prolapse (POP), what is the average effect of the addition of perioperative pelvic floor muscle training on pelvic organ prolapse symptoms, pelvic floor muscle strength, quality of life, sexual function and perceived improvement after surgery? DESIGN: Randomised controlled trial with concealed allocation, blinded assessors, and intention-to-treat analysis. PARTICIPANTS: Ninety-six women with an indication for POP surgery. INTERVENTION: The experimental group received a 9-week pelvic floor muscle training protocol with four sessions before the surgery and seven sessions after the surgery. The control group received surgery only. OUTCOME MEASURES: Symptoms were assessed using the Pelvic Floor Distress Inventory (PFDI-20), which is scored from 0 'unaffected' to 300 'worst affected'. Secondary outcomes were assessed using vaginal manometry, validated questionnaires and Patient Global Impression of Improvement, which is scored from 1 'very much better' to 7 'very much worse'. All participants were evaluated 15 days before surgery, and at Days 40 and 90 after surgery. RESULTS: There was no substantial difference in POP symptoms between the experimental and control groups at Day 40 (31 (SD 24) versus 38 (SD 42), adjusted mean difference -6, 95% CI -25 to 13) or Day 90 (27 (SD 27) versus 33 (SD 33), adjusted mean difference -4, 95% CI -23 to 14). The experimental group perceived marginally greater global improvement than the control group; mean difference -0.4 (95% CI -0.8 to -0.1) at Day 90. However, the estimated effect of additional perioperative pelvic floor muscle training was estimated to be not beneficial enough to be considered worthwhile for any other secondary outcomes. CONCLUSION: In women undergoing POP surgery, additional perioperative pelvic floor muscle training had negligibly small effects on POP symptoms, pelvic floor muscle strength, quality of life or sexual function. TRIAL REGISTRATION: ReBEC, RBR-29kgz5.