Plain English Summary
Background and study aims
Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Two thirds of women initially choose a vaginal support pessary to treat their prolapse symptoms. It is usually fitted at a gynaecological clinic and the woman returns every 6 months to have it removed and changed. However, it is possible that women could remove, clean and reinsert their pessary themselves at home (self-management), thus offering them more confidence in their ability to maintain and improve their own health. The aim of this study is to assess if self-management of prolapse using a vaginal pessary is more effective at improving women's quality of life than standard follow up care.
Who can participate?
Women aged 18 and over with any severity or kind of prolapse who have successfully used a pessary for at least 2 weeks
What does the study involve?
Women are randomly allocated to either self-management or standard care. Women in the standard care group are seen every 6 months in a hospital or community clinic for pessary removal and reinsertion. Women in the self-management group have a 30-minute appointment with a specialist nurse or physiotherapist to ensure they know how to change and clean their pessary and to allow them time to practice. Women have a follow-up phone call 2 weeks after they have received the training to discuss any issues they may have. There is a telephone number that women can call throughout the study to report any issues or concerns they have. All women complete quality of life questionnaires at the start and at 6, 12 and 18 months. Information is collected to find out if self-management is more or less expensive for the NHS and for women. To help understand how and why aspects of self-management may/ may not work some self-management sessions are recorded and some women and health professionals are interviewed.
What are the possible benefits and risks of participating?
The support systems may help to manage the participants’ pelvic organ prolapse. Taking part in the study will not benefit the participant further but the information gained may help improve the treatment of women with pelvic organ prolapse. Pessaries are widely used in the NHS as treatment for pelvic organ prolapse. Both self-management and clinic-based care are already used within the NHS. Participation in the study is to help evaluate the support systems so no additional risks are expected. Women in the self-management group are asked to remove, clean and replace their pessary at least once every 6 months. They also receive a leaflet outlining possible complications to look out for. Some of the questions asked may seem personal but the information is important to help understand the study in full.
Where is the study run from?
St Mary's Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2017 to July 2021
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Carol Bugge
carol.bugge@stir.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Carol Bugge
ORCID ID
http://orcid.org/0000-0002-4071-0803
Contact details
University of Stirling
Pathfoot Building
Stirling
FK9 4LA
United Kingdom
+44 (0)1786 466109
carol.bugge@stir.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 16/82/01
Study information
Scientific title
A multi-centre randomised controlled trial , with process evaluation, to test the clinical and cost-effectiveness of self-management of vaginal pessaries to treat pelvic organ prolapse, compared to standard care to improve women's quality of life
Acronym
TOPSY
Study hypothesis
To determine the clinical and cost effectiveness of self-management of vaginal pessaries to treat pelvic organ prolapse, compared to standard pessary care according to the measurement of condition-specific quality of life.
Ethics approval
Approved 23/02/2018, West of Scotland Research Ethics Committee 03 (Clinical Research and Development, West Glasgow, Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SJ, UK; Tel: +44 (0)141 232 1807; Email: WoSREC3@ggc.scot.nhs.uk), REC ref: 17/WS/0267
Study design
Multi-centre randomised controlled trial with nested process evaluation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pelvic organ prolapse
Intervention
Women with any severity or kind of prolapse will be invited to take part in the study as long as they have successfully used a pessary for at least 2 weeks. Eligible women who provide written consent will be assigned randomly to either self-management or standard care. Women in the standard care group will be seen every 6 months in a hospital or community clinic for pessary removal and reinsertion. Women in the self-management group will have a 30 minute teaching appointment with a specialist nurse or physiotherapist trained in self-management delivery to ensure they know how to change and clean their pessary and to allow them time to practice. Women will have a follow up phone call 2 weeks after they have received the training to discuss any issues they may have. There will be a telephone number that women can call throughout the study to report any issues or concerns they have.
All women will complete quality of life questionnaires at the start and at 6, 12 and 18 months. Information will be collected to find out if self-management is more or less expensive for the NHS and for women. To help understand how and why aspects of self-management may/may not work some self-management sessions will be recorded and some women and health professionals will be interviewed.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months
Secondary outcome measures
1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months
2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months
3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months
4. Need for other prolapse treatment, measured at 6, 12 and 18 months
5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months
6. Treatment acceptability, measured at at baseline and 18 months
7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months
8. Pessary complications, measured at baseline, 6, 12 and 18 months
9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months
10. Adherence to self-management/standard pessary care, measured continuously throughout trial
11. Crossover to other group, measured continuously throughout trial
Overall trial start date
01/11/2017
Overall trial end date
31/01/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women with pelvic organ prolapse of any type or stage
2. Aged ≥18 years
3. Women treated with a vaginal pessary
4. Pessary retained for 2 weeks or more
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
330
Participant exclusion criteria
1. Women with a shelf or Gellhorn pessary as these are difficult for women to remove and replace themselves
2. Women lacking in manual dexterity, e.g. those with arthritis, as women would not be able to remove and replace her own pessary
3. Women judged by the treating clinician to have a cognitive deficit such that she would be unable to give informed consent or understand self-management instruction
4. Pregnant women
Recruitment start date
01/05/2018
Recruitment end date
31/01/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mary's Hospital
Warrell Unit
Oxford Road
Manchester
M13 9WL
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study protocol will be available on the NIHR website and the study website (https://w3.abdn.ac.uk/hsru/topsy) and will be published in an academic journal. The statistical analysis plan will be available as an appendix in the final report which will also be published on the NIHR website. Final NIHR HTA report due July 2021. Aim to publish in journals and present findings at both national and international conferences.
IPD sharing statement
All data requests should be submitted to Suzanne Hagen (S.Hagen@gcu.ac.uk) for consideration. Access to anonymised data may be granted following review.
Intention to publish date
31/07/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 process evaluation protocol in https://pubmed.ncbi.nlm.nih.gov/33032651/ (added 14/10/2020)
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/33032644/ (added 14/10/2020)