Condition category
Urological and Genital Diseases
Date applied
26/09/2017
Date assigned
06/10/2017
Last edited
06/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://w3.abdn.ac.uk/hsru/topsy

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

West of Scotland REC 03 or 05 - submission pending

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 measures

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

31/07/2021

Reason abandoned

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

31/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
Warrell Unit Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

University of Stirling

Sponsor details

-
Stirling
FK9 4LA
United Kingdom

Sponsor type

University/education

Website

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

Federal/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
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes