During the COVID-19 pandemic we are continuing to follow-up all women who are taking part in TOPSY. You will continue to receive your questionnaires at 6,12 and 18 months. Some of you have opted to complete these questionnaires via email. If you complete the questionnaires this way, please keep doing this as normal.
Some of you have opted to complete the questionnaires via a paper booklet that we post to you and you send back in a pre-paid envelope. We are still posting these when we can. They might appear through your letter box a little earlier than usual, or a little later, but please can you complete and return these in the envelope provided as soon as it is safe for you to do so.
If you have opted for a paper questionnaire but can’t return this to us for any reason, and you would be willing to complete via email, please send your name and email address to TOPSY@gcu.ac.uk and we can arrange this.
If you are due for your 18 month TOPSY study clinic appointment, instead of an appointment one of the nurses or clinicians from your centre will call you to ask you some questions over the phone. An alternative clinic appointment will be made for you when clinics are up and running as normal.
If you have any concerns or worries about your pessary, please call the number given to you by your clinic. However you can also email TOPSY@gcu.ac.uk or call 0141 331 3516 and leave a message. All messages will be picked up and somebody from the study office will return your call.
You can also find information about COVID-19 from the NHS websites in nhs.uk/conditions/coronavirus-covid-19/" target="_blank">England ,Scotland, Wales and Northern Ireland.
There is also information about COVID-19 on the UK government website.
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.
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.
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.
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.
The study is sponsored by the University of Stirling and the Trial office is based at the NMAHP Research Unit at Glasgow Caledonian University.
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.