TOPSY trial – Treatment Of Prolapse with Self-care pessarY

• Research type

  Research Study

• Full title

  A multicentre randomised controlled 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.

• IRAS ID

  234662

• Contact name

  Carol Bugge

• Contact email

  carol.bugge@gcu.ac.uk

• Sponsor organisation

  Glasgow Caledonian University

• ISRCTN Number

  ISRCTN62510577

• Clinicaltrials.gov Identifier

  REC reference number, 17/WS/0267

• Duration of Study in the UK

  3 years, 3 months, 31 days

• Research summary

  Summary of Research
  Pelvic organ prolapse (prolapse) is a common condition in women where the bladder, bowel or womb descend into the vagina and cause symptoms that adversely affect quality of life. Many women choose a vaginal pessary to treat their prolapse symptoms. The pessary is usually fitted at a gynaecological clinic and the woman returns to clinic for pessary changes. It is possible that women could remove, clean and reinsert their pessary themselves at home, thus offering them more confidence in their ability to manage their own health (self-management).
  This 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 (visiting the clinic every six months).
  Women with any severity or kind of prolapse and who have used a pessary for at least two weeks will be invited to take part. They will receive written information about the study and if willing to take part they will be randomly assigned to either self-management or standard care. Women in the standard care group would be seen approximately every 6 months in a clinic for pessary removal and reinsertion. Woman in the self-management group will have a thirty minute appointment with a healthcare professional to teach them the necessary pessary care. Woman will asked to change their pessary within two weeks of the appointment and they will be telephoned to assess their ability to self­manage. They will also be given a phone number to call if they have any pessary problems.

  Women will be asked to fill out questionnaires at the start of the study and 6, 12 and 18 months later. To help understand how and why aspects of self-management may or may not work we will record some self-management sessions and interview some women and healthcare professionals.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Ffundingawards.nihr.ac.uk%252Faward%252F16%252F82%252F01%2FNBTI%2FhSC4AQ%2FAQ%2Fffcb944b-77e5-4f60-9d49-2f3000276c91%2F1%2FJnOnOB-la5&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cbcfb3400de08451dc62608dcd8c4b666%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638623586609384815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=CT6JCD668M9Qukd8wDnN6vIMOhC8zg7F8omPGU%2Bcvug%3D&reserved=0

• REC name

  West of Scotland REC 3

• REC reference

  17/WS/0267

• Date of REC Opinion

  23 Feb 2018

• REC opinion

  Further Information Favourable Opinion