Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary careBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7378 (Published 22 December 2014) Cite this as: BMJ 2014;349:g7378
- Marian Wiegersma, PhD student and general practice trainee,
- Chantal M C R Panman, PhD student and general practice trainee,
- Boudewijn J Kollen, epidemiologist,
- Marjolein Y Berger, GP and professor,
- Yvonne Lisman-Van Leeuwen, epidemiologist,
- Janny H Dekker, GP and associate professor
- 1University of Groningen, University Medical Center Groningen, Department of General Practice, FA21, PO Box 196, 9700 AD Groningen, Netherlands
- Correspondence to: J H Dekker
- Accepted 10 November 2014
Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.
Design Randomised controlled trial.
Setting Dutch primary care.
Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.
Interventions Pelvic floor muscle training versus watchful waiting.
Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), 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 in symptoms.
Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.
Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.
Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.
We thank Aaltje Schram, Bert Messelink, Truuske De Bock, and Karin Vermeulen for their contributions to the design of this study. We also thank the participating general practices for their ongoing support and all the participants for their invaluable contribution to this study.
Contributors: MW collected the data, did the analysis, and wrote the paper. CMCRP collected the data and contributed to the writing of the paper. BJK assisted with the analysis and contributed to the writing of the paper, MYB assisted in the study design and contributed to the writing of the paper. YL-VL assisted in the study design, assisted with the analysis, and contributed to the writing of the paper. JHD designed the study, was project leader, and contributed to the writing of the paper. JHD is the guarantor.
Funding: This trial is funded by the Netherlands Organization for Health Research and Development (ZonMw), project number 4201.1001. The funder played no role in the study design; in the collection, analysis, and interpretation of data; or in the writing of the report and the decision to submit the article for publication. All researchers were independent from funders.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The Medical Ethics Committee of the University Medical Centre Groningen (Netherlands) (METc2009.215) approved this study. All participants gave written informed consent.
Transparency declaration: The lead author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Data sharing: No additional data available.
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