Randomised controlled trial of the clinical and cost effectiveness of supervised pelvic floor muscle training plus vaginal pessary compared to supervised pelvic floor muscle training alone for management of pelvic organ prolapse

Background Prolapse causes distressing vaginal, bladder, bowel and sexual symptoms, and impaired quality of life. 40% of women over 50 years have prolapse, and symptomatic prolapse affects 11%. 9.5% of UK women have prolapse surgery and 15.8% have re-operation. Supervised pelvic floor muscle training (PFMT) is effective for treating and preventing prolapse symptoms and is first line management. A pessary, inserted vaginally to hold the prolapsed organs in place, also provides symptom relief. Two out of 3 women try a pessary when offered. PFMT and pessary are used together by some clinicians, however supporting evidence is lacking. NICE identified this as a research gap. Inserting a pessary may allow the pelvic floor muscles to be trained more effectively by reducing the obstructing prolapse, leading to a better treatment outcome. We will establish effectiveness and cost-effectiveness of PFMT plus pessary, and investigate intervention context and implementation, to inform evidence-based healthcare. Research question Is supervised PFMT plus vaginal pessary as an adjunct more effective and cost-effective than supervised PFMT alone at reducing symptoms at 12 months for women with prolapse? Aims & objectives 1)To undertake a randomised controlled trial to establish if a supervised PFMT programme with the addition of a vaginal pessary, compared to supervised PFMT alone, is more effective in improving prolapse symptoms, sexual function, prolapse-specific and general quality of life, adherence to treatment, perceived treatment benefit and satisfaction, pelvic floor muscle function and prolapse severity at 12 months. 2)To undertake an internal pilot to ensure the trial can recruit, randomise and retain sufficient numbers of participants, and deliver the intervention as planned. 3)To undertake an economic evaluation to establish whether supervised PFMT plus vaginal pessary is cost-effective compared to supervised PFMT alone. 4)To undertake a process evaluation (PE) to inform trial recruitment methods, and to explore and expand the proposed programme theory by understanding intervention context and implementation (fidelity, acceptability and adherence) within the trial. Methods Multicentre parallel group, superiority randomised controlled trial with internal pilot, mixed methods PE and economic evaluation, and outcomes measured at 6 and 12 months (primary outcome). The pilot and PE will optimise recruitment, randomisation and fidelity to intervention delivery. The PE will also explain the proposed programme theory. Patient & Public Involvement has been embedded in all aspects of the research. Timelines Duration 42 months. Months 0-6 approvals, develop documentation and data management system, pilot centre set-up; 7-12 internal pilot; 7-24 participant recruitment; 12-35 trial follow up at 6/12 months; 7-36 process evaluation data collection; 36-40 trial data analysis; 7-40 process evaluation data analysis; 40-42 reporting and dissemination. We aim to recruit on average 4 women per month in 13 centres (once established) over 18 months. Centre referral numbers support this recruitment plan. Anticipated impact & dissemination Dissemination would occur through varied accessible as well as academic formats. The anticipated impact is improved health and well-being for women with prolapse.