Treatment of prolapse with self-care pessary: the TOPSY trial
| ISRCTN | ISRCTN62510577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62510577 |
| Secondary identifying numbers | HTA 16/82/01 |
- Submission date
- 26/09/2017
- Registration date
- 06/10/2017
- Last edited
- 22/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
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 |
| Carol.Bugge@gcu.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial with nested process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2017 |
| Completion date | 31/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
University/education
Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom
| Phone | +44 141 331 8882 |
|---|---|
| y.glover@gcu.ac.uk | |
| Website | http://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 | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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? |
|---|---|---|---|---|---|
| Protocol article | process evaluation protocol | 08/10/2020 | 14/10/2020 | Yes | No |
| Protocol article | protocol | 08/10/2020 | 14/10/2020 | Yes | 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 |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 23/11/2023 | 19/12/2023 | Yes | No | |
| Results article | Clinical and cost-effectiveness | 01/05/2024 | 22/05/2024 | Yes | No |
Editorial Notes
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.
