Pelvic floor muscle exercises plus pessary for treatment of prolapse versus pelvic floor muscle exercises alone
| ISRCTN | ISRCTN10890272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10890272 |
| IRAS number | 338183 |
| Secondary identifying numbers | NIHR 160810, CPMS 60082 |
- Submission date
- 22/08/2024
- Registration date
- 24/04/2025
- Last edited
- 09/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Pelvic organ prolapse is when the organs in a woman’s pelvis descend into her vagina. Prolapse is very common, affecting 40% of women over the age of 50, and becomes more common as women age. It has distressing symptoms and negative effects on women’s daily lives. One common treatment is pelvic floor muscle training (PFMT) where women are taught by a specialist physiotherapist or nurse how to exercise the muscles around their vagina. If this is done regularly, over time, it can reduce the symptoms of prolapse. A vaginal pessary is another prolapse treatment. The pessary, which is a plastic or silicone device (often shaped like a ring), is inserted into a woman’s vagina to lift and hold the pelvic organs in place. UK guidelines recommend that women with prolapse consider PFMT treatment, and separately that they can consider pessary treatment. The guidelines suggest that research is needed to find out if adding a pessary to PFMT would be more effective than PFMT alone. Some physiotherapists in the UK have told us they combine these treatments in their practice, and they think it can be beneficial as it holds up the prolapse during PFMT, and this improves symptoms more. One study in a single hospital in Hong Kong has looked at this question, but the study had some limitations, so a larger study with stronger methods is needed. If combining these two treatments gives better results, this knowledge can be used to improve the lives of women with prolapse. It may also reduce NHS costs if women do not then need further prolapse treatment, such as surgery. This research aims to find out if wearing a vaginal pessary whilst exercising pelvic floor muscles is better at improving symptoms than exercising pelvic floor muscles without a pessary, for women with prolapse.
Who can participate?
Patients over the age of 18 who have been referred for PFMT for pelvic organ prolapse
What does the study involve?
Eligible patients who consent to taking part will be allocated at random, by a computer, to one of the two groups:
Group 1: Women in the PFMT and pessary group will have a 16-week PFMT programme and have a vaginal pessary. The pessary can be kept in or removed and re-inserted from time to time, depending on preference
Group 2: Women in the PFMT group will have a 16-week PFMT programme.
The PFMT programme in both groups will involve attending 5 appointments, with at least 3 appointments being face to face, will be tailored to individuals and a daily pelvic floor muscle home exercise programme prescribed. Between each appointment, participants will be asked to complete a daily diary for one week to record pelvic floor exercises completed and pessary use (for those in Group 1). The study team will collect information on women’s prolapse symptoms, their quality of life, whether they feel an improvement, how acceptable they found treatment, whether they had to have other prolapse treatment and whether their pelvic floor muscles are stronger. This information will be recorded after 6 and 12 months, and the 2
Groups of women will be compared to see which treatment is best and which offers the NHS the best value for money. Women in each group will be asked about their experiences. NHS staff will also be asked about their experiences of the study and the treatments. This will help to explain why the combined treatment did or did not work better for women.
What are the possible benefits and risks of participating?
The PFMT and pessary care patients receive may help them manage their pelvic organ prolapse and improve their quality of life. The information collected in this study may help improve the care of other women with pelvic organ prolapse in the future.
Where is the study run from?
The study is sponsored by Glasgow Caledonian University, based in Scotland, UK. The research is being carried out by teams of experienced doctors, nurses, physiotherapists and researchers working from a number of centres based throughout the UK.
When is the study starting and how long is it expected to run for?
May 2023 to April 2028. Recruitment to the study begins in May 2025 and is expected to run until October 2027.
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (HTA), UK
Who is the main contact?
Dr Catriona O’Dolan (Trial Manager), PEPPY@gcu.ac.uk
Contact information
Public, Scientific, Principal Investigator
Cowcaddens road
Glasgow
G4 0BA
United Kingdom
 ORCID ID |
0000-0002-9741-9160 |
|---|---|
| Phone | +44 (0)7920751281 |
| s.hagen@gcu.ac.uk |
Scientific
Research Centre for Health, School of Health & Life Sciences
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| ORCID ID |
0000-0002-9765-2464 |
|---|---|
| Phone | +44 (0)141 331 8355 |
| Catriona.ODolan@gcu.ac.uk |
Public
Research Centre for Health, School of Health & Life Sciences
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| Phone | +44 (0)141 331 8355 |
|---|---|
| PEPPY@gcu.ac.uk |
Study information
| Study design | Pragmatic multicentre parallel-group superiority randomized controlled trial with an internal pilot and parallel process evaluation and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at https://www.peppy-trial.co.uk/Public/Public/index.cshtml |
| Scientific title | 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 |
| Study acronym | PEPPY |
| Study objectives | Inserting a pessary may allow the pelvic floor muscles to be trained more effectively that pelvic floor muscle training alone by reducing the obstructing prolapse, leading to a better treatment outcome. |
| Ethics approval(s) |
Approved 13/02/2025, West of Scotland REC 4 (272 Bath Street, Glasgow, G2 4JR, United Kingdom; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 25/WS/0001 |
| Health condition(s) or problem(s) studied | Pelvic organ prolapse |
| Intervention | Supervised pelvic floor muscle training (PFMT) is an effective non-surgical option for treating and preventing prolapse symptoms and is first-line management. A vaginal pessary, a support device inserted vaginally to hold the prolapsed organs in place, also provides symptom relief, and two-thirds of women try a pessary when offered. The researchers will invite women with prolapse who are starting PFMT treatment to take part in the study. Women who agree to take part will have an equal chance of receiving PFMT alone (group 1) or receiving a pessary fitted (group 2). The researchers will collect information on women’s prolapse symptoms, their quality of life, whether they feel an improvement, how acceptable they found treatment, whether they had to have other prolapse treatment and whether their pelvic floor muscles are stronger. The researchers will record this information after 6 and 12 months, and compare the two groups of women to see which treatment is best and which offers the NHS the best value for money. They will ask women in each group about their experiences. They will also ask NHS staff about their experiences of the study and the treatments. This will help explain why the combined treatment did or did not work better for women. Randomisation will be made using a secure web-based database and randomisation system developed and hosted by the Clinical Trials Unit (The Centre for Healthcare Randomised Trials (CHaRT) at the University of Aberdeen). Allocation will be minimised on age (<52/ ≥52 years), prolapse severity (POP-Q System: stage 0/1, stage 2, stage 3/4) and centre, ensuring balance between randomised groups in these factors. |
| Intervention type | Mixed |
| Primary outcome measure | Participant-reported symptoms of pelvic floor dysfunction measured using the Pelvic Floor Dysfunction Inventory-20 (PFDI-20) questionnaire at baseline, 6 and 12 months |
| Secondary outcome measures | 1. Participant-reported condition-specific quality of life measured using the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) at baseline, 6 and 12 months 2. Patient-reported generic quality of life measured using the general health-related quality of life questionnaire (EQ-5D-5L) at baseline, 6 and 12 months 3. Patient-reported improvement in condition measured using the Global Impression of Improvement (PGI-I) scale validated for prolapse at 6 and 12 months, compared to Patient Global Impression of Severity (PGI-S) at baseline 4. Patient-reported sexual function measured using ICIQ-Vaginal Symptoms module (ICIQ-VS), Sexual Matters subscale at baseline, 6 and 12 months 5. Patient-reported uptake of other prolapse treatment measured using items on unvalidated items on the participant questionnaire at baseline, 6 and 12 months 6. Patient-reported self-efficacy for Pelvic Floor Muscle Training measured using Pelvic Floor Muscle Exercise Self-efficacy Scale at baseline, 6 and 12 months 7. Patient-reported intervention adherence measured using the participant exercise and pessary use diary completed for 7 days at 4 timepoints during the intervention period, and 6 and 12-month questionnaires 8. Pelvic floor muscle strength and function measured using the Modified Oxford Scale (MOS), assessed by a clinician via digital palpation at baseline and 12 months 9. Prolapse severity measured by a clinician using a Pelvic Organ Prolapse Quantification (POP-Q) method at baseline and 12 months 10. Economic outcomes measured using Quality Adjusted Life Years (QALYS) calculated from the EQ-5D-5L at baseline, 6 and 12 months 11. Economic outcomes measured using the Healthcare utilisation questionnaire at baseline, 6 and 12 months |
| Overall study start date | 17/05/2023 |
| Completion date | 30/04/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 552 women (276 per group) |
| Key inclusion criteria | Women who have been referred for PFMT for prolapse, even if they have had previous prolapse treatment (PFMT, pessary, surgery) as currently PFMT would be offered for all such women. If a woman has significant vaginal tissue atrophy, participation in the trial would be delayed until after this has been treated. |
| Key exclusion criteria | 1. Women for whom prolapse is not the main presenting problem 2. Women currently using a vaginal pessary (unless they discontinue for 1 month) 3. Women who are pregnant or less than 6 months postnatal 4. Women having active treatment for pelvic cancer 5. Women with severe vulval disease 6. Women who have cognitive impairment affecting capacity to give informed consent |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 31/10/2026 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
United Kingdom
Sponsor information
University/education
Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom
| Phone | +44 (0)7920751281 |
|---|---|
| Sharron.Dolan@gcu.ac.uk | |
| Website | https://www.gcu.ac.uk/ |
"ROR" |
https://ror.org/03dvm1235 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. A lay summary of the findings will be sent to participants and disseminated to healthcare professionals involved in the trial, centre PIs and staff members. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from from the Chief Investigator, Suzanne Hagen (s.hagen@gcu.ac.uk). |
Editorial Notes
09/05/2025: Contact details updated.
22/08/2024: Study's existence confirmed by the NIHR.
