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WELCOME TO THE TOPSY STUDY

A Multi-centre randomised control trial, with nested 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

What is TOPSY?

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 TOPSY study aims 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.

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 woman 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. Woman in the self-management group will 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. They will still be fully supported by the clinical team should they require assistance.
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Can I take part?

If you would like to find out information about the TOPSY trial and to see if there are any recruiting sites near you, please contact the TOPSY Glasgow office either by email: TOPSY@gcu.ac.uk or call 0141 331 3516 and ask to speak to the TOPSY Trial mangager , Dr Kirsteen Goodman.

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If you are interested in taking part, or have any questions

Where can I take part?

Ayrshire and Arran (Ayr Hospital)

Key people:

Investigator:

  • Dr Wael Agur

Address:

Ayr Hospital
Outpatient Department
Dalmillington Road
Ayr
KA6 6DX
Ayrshire and Arran (University Hospital Crosshouse)

Key people:

Investigator:

  • Dr Wael Agur

Address:

Research and Development
58 Lister Street
University Hospital Crosshouse
Kilmarnock
KA2 0BB
NHS Grampian (Aberdeen Royal Infirmary))

Key people:

Investigator:

  • Dr Christine Hemming

Address:

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
Croydon Health Services NHS Trust

Key people:

Investigator:

  • Dr Ranee Thakar

Address:

The Orchid Suite, Croydon Pelvic Floor Centre
Purple Zone, Croham Building
1st Floor Croydon University Hospital
530 London Road, Croydon
CR7 7YE
Manchester University NHS Foundation Trust

Key people:

Investigator:

  • Dr Rohna Kearney

Address:

The Warrell Unit (Women's Outpatient Department)
Saint Mary's Hospital
Manchester University NHS Foundation Trust
Oxford Road, Manchester
M13 9WL
NHS South Tees Hospitals (James Cook University Hospital))

Key people:

Investigator:

  • Dr Aethele Khunda

Address:

NHS South Tees Hospitals
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
NHS Greater Glasgow and Clyde (Queen Elizabeth University Hospital)

Key people:

Investigator:

  • Dr Karen Guerrero

Address:

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G42 5TF
King's College Hospital NHS Foundation Trust

Key people:

Investigator:

  • Prof Linda Cardozo

Address:

Urogynaecology Department
Suite 8, Golden Jubilee Wing
King's College Hospital
Denmark Hill, London
SE5 9RS
Hampshire Hospitals NHS Foundation Trust

Key people:

Investigator:

  • Prof Christian Phillips

Address:

Urogynaecology Department
Sherborne Building Level 1
Basingstoke & North Hampshire Hospital
Aldermaston Road, Basingstoke, Hampshire
RG24 9NA
Cambridge University Hospitals NHS Foundation Trust

Key people:

Investigator:

  • Mr Ashish Pradhan

Address:

Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trus
Cambridge
CB2 0QQ
Sheffield Teaching Hospitals NHS Foundation Trust

Key people:

Investigator:

  • Prof Steve Radley

Address:

Level 4
Jessop Wing Hospital
Sheffield Teaching Hospitals NHSFT
Tree Root Walk, Sheffield
S10 2SF
Birmingham Women's and Children's NHS Foundation Trust

Key people:

Investigator:

  • Dr Pallavi Latthe

Address:

Birmingham Women's & Children's NHS Foundation Tru
Birmingham Women's Hospital
Mindelsohn way, Edgbaston
Birmingham
B15 2TG
Liverpool Women's NHS Foundation Trust

Key people:

Investigator:

  • Miss Gillian Fowler

Address:

Liverpool Women's NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
NHS Lothian (St. John's Hospital and Edinburgh Royal Infirmary)

Key people:

Investigator:

  • Dr Julia Wilkens

Address:

St John's Hospital
Howden Road
Livingston
West Lothian
EH54 6PP
- coming soon

Key people:

Investigator:

Address:

NHS Fife

Key people:

Investigator:

  • Ms Irene Russell

Address:

Research and Development
Level 2, Queen Margaret Hospital
Whitefield Road
Dunfermline
KY12 0SU
County Durham and Darlington NHS Foundation Trust

Key people:

Investigator:

  • Dr Jonathan Bradley

Address:

Research Nurse Office
Trust Head Quarters
University Hospital of North Durham
North Road, Durham
DH1 5TW
University Hospitals Plymouth NHS Trust

Key people:

Investigator:

  • Prof Robert Freeman

Address:

Research Offices, MSCP, Level 2
Bircham Park Offices
1 Roscoff Rise
Derriford, Plymouth
PL6 5FP
- coming soon

Key people:

Investigator:

Address:

Yeovil District Hospital NHS Foundation Trust

Key people:

Investigator:

  • Mrs Fatima Shah

Address:

Yeovil District Hospital
Higher Kingston
Yeovil
Somerset
BA21 4AT
Taunton and Somerset NHS Foundation Trust

Key people:

Investigator:

  • Mr Adel Naguib

Address:

Women and Children's Research Office (TOPSY)
Starling Clinic
Musgrove Park Hospital
Taunton, Somerset
TA1 5DA
The Newcastle upon Tyne Hospital NHS Foundation Trust

Key people:

Investigator:

  • Dr Karen Brown

Address:

Royal Victoria Hospital
Newcastle upon tyne
NE1 4LP
- coming soon

Key people:

Investigator:

Address:

Norfolk and Norwich University NHS Foundation Trust

Key people:

Investigator:

  • Mr Ilias Giarenis

Address:

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY

Study news

Recruitment

250/330

Trial sites

Latest addition to sites:

Norfolk and Norwich University NHS Foundation Trust
The Newcastle upon Tyne Hospital NHS Foundation Trust
Taunton and Somerset NHS Foundation Trust
Yeovil District Hospital NHS Foundation Trust

Key facts about the study and documents

What is this study about?

AIM
To see if clinic based care or self-management is better at improving women’s quality of life when they are using a vaginal pessary for treatment of pelvic organ prolapse.

What is involved?
For more information about what is involved in the TOPSY study please click on the link for the following;
1. The study flow chart which gives an overview of the study.
2. The five different Patient Information Leaflets for the different aspects of the study.


How long will the study last?
We aim to recruit 330 women to the trial. Recruitment will start in May 2018 and women will be followed up for 18 months. The study will last for 45 months in total and end in July 2021.

Key contacts

Click on cards to find out more

Organisation

Funding acknowledgement
This study is funded by the NIHR HTA (project number 16/82/01). More information about NIHR can be found at the NIHR website (www.nihr.ac.uk).

Department of Health disclaimer
The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Sponsorship
The study is sponsored by the University of Stirling and the Trial office is based at the NMAHP Research Unit at Glasgow Caledonian University.

General Data Protection Regulation (GDPR)
Participant Information

The University of Stirling is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The University of Stirling will keep identifiable information about you for 5 years after the study has finished. Appropriately qualified research staff from University of Stirling, University of Aberdeen and Glasgow Caledonian University may look at your research records in line with their responsibilities to the TOPSY study.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.