Treatment of prolapse with self-care pessary: the TOPSY trial

ISRCTN	ISRCTN62510577
DOI	https://doi.org/10.1186/ISRCTN62510577
Protocol serial number	HTA 16/82/01
Sponsor	Glasgow Caledonian University
Funder	National Institute for Health Research

Submission date: 26/09/2017
Registration date: 06/10/2017
Last edited: 18/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
Glasgow Caledonian University (UK)

When is the study starting and how long is it expected to run for?
November 2017 to January 2024

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Prof Carol Bugge, Carol.Bugge@gcu.ac.uk

Contact information

Prof Carol Bugge
Scientific

School of Health & Life Sciences
Glasgow Caledonian University
Govan Mbeki Building
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom

ORCID ID	0000-0002-4071-0803
Phone	+44 (0)141 331 8796
Email	Carol.Bugge@gcu.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomized controlled trial with nested process evaluation
Secondary study design	Randomised controlled trial
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
Study acronym	TOPSY
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	Pelvic organ prolapse
Intervention	Current intervention as of 31/08/2022: 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. Eligible participants who have opted in will also be sent a questionnaire at 4-year follow-up. _____ Previous 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
Primary outcome measure(s)	Current primary outcome measure as of 31/08/2022: Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months and 4 years _____ Previous primary outcome measure: Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 31/08/2022: 1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months and 4 years 2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months and 4 years 3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months and 4 years 4. Need for other prolapse treatment, measured at 6, 12 and 18 months and 4 years 5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months and 4 years 6. Treatment acceptability, measured at at baseline and 18 months and 4 years 7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months and 4 years 8. Pessary complications, measured at baseline, 6, 12 and 18 months and 4 years 9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months and 4 years 10. Adherence to self-management/standard pessary care, measured continuously throughout trial 11. Crossover to other group, measured continuously throughout trial 12. Everyday physical activity assessed using the International Physical Activity Questionnaire modified for the elderly (IPAQ-E) at 4 years. The four questions ask about the amount of time in days and minutes, people spend sitting, walking, doing moderate and vigorous physical activity in the last 7 days. _____ Previous 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
Completion date	31/01/2024

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	Female
Target sample size at registration	330
Total final enrolment	340
Key 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
Key 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
Date of first enrolment	01/05/2018
Date of final enrolment	31/01/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Mary's Hospital

Warrell Unit
Oxford Road
Manchester
M13 9WL
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		23/11/2023	19/12/2023	Yes	No
Results article	Clinical and cost-effectiveness	01/05/2024	22/05/2024	Yes	No
Results article	Long term follow-up	20/08/2025	20/08/2025	Yes	No
Protocol article		08/10/2020	14/10/2020	Yes	No
Protocol article	Process evaluation protocol	08/10/2020	14/10/2020	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse	05/09/2022	06/09/2022	Yes	No
Other publications	Multi-method process evaluation	05/12/2025	18/12/2025	Yes	No
Study website		11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2025: Publication reference added.
20/08/2025: Publication reference added.
22/05/2024: Publication reference added.
19/12/2023: Publication reference added.
06/09/2022: Publication reference added.
31/08/2022: The following changes have been made:
1. The intervention has been changed.
2. The primary outcome measure has been changed.
3. The secondary outcome measures have been changed
4. The intention to publish date has been changed from 31/07/2022 to 31/01/2025.
5. The sponsor has been changed from the University of Stirling to Glasgow Caledonian University.
30/08/2022: The following changes have been made:
1. The scientific contact details have been updated.
2. The overall trial end date has been changed from 31/01/2022 to 31/01/2024 and the plain English summary updated accordingly.
14/01/2022: The total final enrolment was added.
14/10/2020: Publication references added.
28/11/2019: IPD sharing statement and ethics approval details added.
22/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2019 to 31/01/2020.
2. The overall trial end date was changed from 31/07/2021 to 31/01/2022.
3. The intention to publish date was changed from 31/07/2021 to 31/07/2022.