A multicentre randomised controlled trial of a pelvic floor muscle training intervention for the secondary prevention of pelvic organ prolapse (PREVPROL)

Research output: Contribution to journalArticle

Authors

Colleges, School and Institutes

Abstract

Background: Pelvic floor muscle training (PFMT) in women seeking treatment for prolapse reduces prolapse severity and symptoms. PFMT may also be effective in secondary prevention of prolapse and the need for future treatment.

Methods: We conducted a parallel-group, multicentre, randomised controlled trial in women from a longitudinal study of pelvic floor function after childbirth. Eligible women had stage I to III prolapse but had not sought treatment. Those with major stages of prolapse (stage IV), or no prolapse (stage 0), were excluded. Women were randomly assigned (1:1), by remote computer allocation, to receive one-to-one PFMT (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based PFMT classes and a DVD for home use (intervention group), or a lifestyle advice leaflet for women with prolapse (control group). Women and intervention physiotherapists could not be blinded to treatment. The primary outcome was self-report of prolapse symptoms (Pelvic Organ Prolapse Symptom Score, POP-SS) at two years, with lower scores indicating fewer symptoms.

Findings: 414 women were randomised (207 intervention, 207 control), with one post-randomisation exclusion per group (206 per group analysed). At baseline, 97% of women had prolapse above or at the hymen. Mean POP-SS score at two years was 3·2 (SD 3·4) for the intervention group, significantly lower than the control group (mean 4·2 (SD 4·4)), adjusted mean difference -1·01 (95% CI −1·70 to −0·33). The mean symptom score stayed similar across time-points in the control group, but decreased in the intervention group. Uptake of further treatment for prolapse within two years was less common in the intervention group (5·9% vs 14·4%, OR=0·29 (95% CI 0·12 to 0·71), p=0·007). Three adverse events occurred in the intervention group (one fall, one pain in tail bone, one chest pain and shortness of breath).

Interpretation: We provide evidence that PFMT leads to a small, but likely important reduction in prolapse symptoms, and lower uptake of prolapse treatment. This is important information for women and caregivers considering preventive strategies.

Details

Original languageEnglish
JournalThe Lancet
Early online date21 Dec 2016
Publication statusE-pub ahead of print - 21 Dec 2016