1. Interview Study Patient Information Leaflet
IRAS ID:
Woman consents to take part in TOPSY study
Exploring women’s experiences of symptoms and treatment: An interview study linked to the TOPSY Study
Interview Study
Patient Information Leaflet
Woman sent information about the interview study
Contacted by a researcher to discuss and answer questions on the interview study
Woman decides to take part in the interview study
Interviews take place at:
Prior to starting with the allocated support system: face-to-face interview lasting about 30 minutes
At 18 months: face-to-face interview lasting about 60 minutes
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2. What is the purpose of the study?
Introduction
Thank you for already agreeing to be part of the TOPSY study. The study tests two ways of supporting women who have a vaginal pessary in place for pelvic organ prolapse to see if one way of support is better than the other.
You are invited to take part in an additional research study to complement the TOPSY study. Before you decide, it is important for you to understand why the research is being done and what it involves. Please take time to read the following information carefully and discuss it with others if you wish. One member of the research team will take 5 to 10 minutes to go through the information sheet with you and answer any questions you have about the study. Please ask us if anything is unclear or if you would like more information. Take the time you need to decide whether or not you wish to take part.
What is the purpose of the study?
This study is based around interviews with some of the women in the study. It aims to explore women’s experience of pelvic organ prolapse, a vaginal pessary as treatment and of the support system they receive, as part of the study.
Why have I been invited to take part?
You have been asked to take part because you are a woman with pelvic organ prolapse, treated with a vaginal pessary who has agreed to take part in the TOPSY study. We are aiming to talk to approximately thirty women. We would like to talk to women of different ages and who live in different areas of the UK.
Can I contact a member of the research team for further information?
If you have received this information leaflet you will automatically be contacted by telephone by a member of the research team. They can provide further information on this study, answer your questions and tell you about the next steps should you wish to continue with being part of this study.
If you have any further questions about the study at any stage, please feel free to contact:
Dr Carol Bugge OR Dr Melanie Dembinsky
Associate Professor Research Fellow
Faculty of Health Sciences& Sport Faculty of Health Sciences& Sport University of Stirling University of Stirling
Stirling Stirling
FK9 4LA FK9 4LA /
If you would like information about research more generally please contact:
Professor Jayne Donaldson
Dean of Faculty
Faculty of Health Sciences and Sport
University of Stirling
FK9 4LA
Information about the study is available on the web site:
Thank you for reading this and considering taking part in this study.
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3. What will happen to the results of the study?
The results will help us to understand women’s experience of pelvic organ prolapse and the support that women receive when they are treated with a vaginal pessary. We hope that the results will be published in journals so that others can learn from the results. If you wish, when the study is complete, we will send you information about the findings.
Who is organising and funding the study?
The study is sponsored by the University of Stirling, based in the UK, and is being funded by the National Institute of Health Research. The research is being carried out by a group of experienced doctors, nurses, physiotherapists and researchers along with women who have pelvic organ prolapse. The study has been approved by the West of Scotland Research Ethics Committee 03 and all local NHS sites involved.
We will be using information from you which you provide to us during the interview, such as prolapse stage and care pathway, in order to undertake this study and the University of Stirling will act as the data controller. Your personal data will be securely shared with Glasgow Caledonian University and the Centre for Healthcare Randomised Trials at the University of Aberdeen who are responsible for maintaining the study’s database.
The University of Stirling is 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 in a secure location. After the time, all information will be securely destroyed.
Legal basis for processing personal data
As part of the project we will be recording personal data relating to you. This will be processed in accordance with the General Data Protection Regulation (GDPR); Article 6 (1)(e). Under GDPR the legal basis for processing your personal data will be the official authority of the University.
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Do I have to take part?
No. It is up to you to decide if you want to take part. You can continue to take part in the main TOPSY study but decide not to be involved in this additional interview study.
A member of the “TOPSY Stirling Research team” will telephone you in a few days to describe the interview study, go through the information sheet and answer any questions you have. If, after that, you do decide to take part, we will make an appointment with you for the first interview. At that first interview you will be asked to sign a consent form and given a copy of the form to keep.
You can change your mind at any time and decide not to participate. The treatment and standard of care you receive will not be affected in any way if you decide not to take part now or if you withdraw from the study later.
You will not be paid any expenses for your involvement in this study.
What will happen to me if I take part?
If you agree to take part in this study, you will be interviewed twice; once when you agree to take part and once at 18 months.
The researcher will make an appointment with you for the first interview. That appointment can either be at your home or at the clinic depending on what you would prefer. The interview needs to take place before you start either clinic based care or self management. That first interview will last approximately 30 minutes. The interviewer will ask you about your experience of being recruited into the study, your symptoms, and your experience of being treated with a pessary.
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4. How long will I be involved in the study?
The second, and final, interview will take place 18 months after you join the TOPSY study. That interview can be at your home or at the clinic depending on your preference. It will take approximately one hour. The interviewer will ask you about your symptoms, your experience of clinic based care or self management, and any features of your life that you think affect how you have got on with your pessary and the care over the 18 months of the study. With your consent, all interviews will be recorded.
How long will I be involved in the study?
You will be involved in the study for the same 18 months you are involved in the TOPSY study. During that time you will be interviewed twice by a TOPSY researcher.
Will the information I provide be kept confidential?
Yes. Recordings will be securely stored on a password protected University computer. Aside from your local clinical team, only qualified research staff will have access to your information. Your identification will be removed from transcripts and any information that you do provide will be seen by the research team only. Women who have taken part will not be identified in any way in the reports. Even if we use quotes of things you have said, it will not be possible for others to identify who said it.
Your rights
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. You can find out more about how we use your information:
What are the possible disadvantages or risks of taking part?
We do not anticipate any risks to you from being involved in the interview study. The questions may be of a sensitive nature and some people may find discussing their prolapse and support systems for pessary treatment distressing. If you do, you can stop the interview and/or withdraw from the study. However, some people find it helpful to discuss their opinions and feelings.
What are the possible benefits of taking part?
The study may not help you but the information we gain may help improve treatment of women who use a vaginal pessary as treatment for pelvic organ prolapse.
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. In the first instance contact : Dr Melanie Dembinsky, Research Fellow, telephone – / If you remain unhappy and wish to complain formally, you can do this by contacting your local NHS Complaints Department.
The University’s Data Protection Officer is Joanna Morrow, Deputy Secretary. If you have any questions relating to data protection these can be addressed to in the first instance.
If you remain unhappy, you have the right to lodge a complaint against the University regarding data protection issues with the Information Commissioner’s Office (
Taking part in this study does not affect your normal legal rights. Whether or not you do take part, you will retain the same legal rights as any other patient in the NHS (which include professional indemnity insurance for negligence).
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