Implementation of pelvic floor muscle training for women
Research type
Research Study
Full title
Implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse (PROlapse and PFMT: implementing Evidence Locally - PROPEL).
IRAS ID
179719
Contact name
Margaret Maxwell
Contact email
Sponsor organisation
University of Stirling
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Pelvic Organ Prolapse (POP) can affect up to half the female population aged over 40. Surgery has been the main treatment option but many women end up with an additional prolapse and around 30% have repeat surgery. A recent large scale trial has shown that pelvic floor muscle training (PFMT) is an effective and potentially cost effective treatment and should be recommended as the first treatment option. However, there area limited numbers of physiotherapists specialising in women’s health and prolapse. Research is required to support alternative implementation of PFMT as a first line treatment for POP. The opportunity also exists to examine the longer term outcomes of original trial participants.
This project aims to conduct a Realist Evaluation to study implementation and outcomes of different models of delivery to increase service provision of PFMT across contrasting NHS sites; and to use linked healthcare data for longer term follow up of treatment outcomes for original POPPY trial participants.
Setting: Specialist women's health services in three sites: Glasgow, Leicester and Caithness/Inverness.
Methods: Qualitative data will be collected at 4 time-points across each site to establish an understanding of local contexts and decisions regarding options for delivery of PFMT and to monitor implementation, up-take, adherence and outcomes.
Outcomes: Patient outcomes used in the POPPY trial will be collected at baseline, six months and up to one year follow-up for up to 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). Secondary outcome measures are: quality of life EQ-5D-5L; prolapse severity (POP-Q); and need for further treatment. An economic evaluation will assess the costs and benefits associated with the different delivery models taking account of further health care resource use by the women.
Longer term follow-up of the original POPPY trial participants will be undertaken using record linkage of hospital and outpatient datasets.REC name
Wales REC 7
REC reference
15/WA/0427
Date of REC Opinion
27 Nov 2015
REC opinion
Favourable Opinion