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Bekkenfysiotherapie of afwachten bij een milde urogenitale prolaps? (Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomized controlled trial in primary care) [Dutch] |
Wiegersma M, Panman CMCR, Kollen BJ, Berger MY, Lisman-van Leeuwen Y, Dekker JH |
Nederlands Tijdschrift voor Geneeskunde 2015;159:A8855 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To compare the effect of pelvic floor muscle training (PFMT) and watchful waiting on pelvic floor symptoms in women aged 55 years and over with symptomatic mild pelvic organ prolapse in primary care. DESIGN: Randomised controlled trial in primary care. METHOD: Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Women were randomised to PFMT or watchful waiting. Primary outcome was change in bladder, bowel and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients' perceived change of symptoms. RESULTS: Of the 278 women who were randomised to PFMT (n = 145) or watchful waiting (n = 142), 250 (87%) completed followup. Participants in the PFMT group improved by 9.1 (95% CI 15.4 to 2.8) points more on the PFDI20 than did participants in the watchful waiting group (p = 0.005). Of women in the PFMT group, 57% (82/145) reported an improvement of overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (p < 0.0001). Other secondary outcomes showed no significant difference between the groups. CONCLUSION: Although PFMT led to a significantly greater improvement in PFDI20 score, the difference between groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the PFMT group reported an overall improvement of symptoms.
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