PROSPECT
 
PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials


Around 1 in 10 women will need prolapse surgery at some point in their lives. There is not enough evidence from research to identify which operation is best. New techniques have been introduced which use mesh to reinforce the surgery, but these have not been properly evaluated, especially in terms of how well they improve prolapse symptoms. In particular, a recent review by NICE (the National Institute for Clinical Excellence) has found that there is insufficient information on the efficacy and safety of mesh used in prolapse surgery in women. 

The study will be carried out in at least 15 hospitals in the UK. We will randomise women having an anterior and/or posterior vaginal wall prolapse operation to one of two trials:
  1. A woman who is having her first repair operation will be randomised to one of: a) a standard anterior or posterior prolapse repair, b) a standard repair with a biological graft inlay to support the stitches; or c) a standard repair with a non-absorbable mesh inlay to support the stitches.

  2. A woman who is having a second or subsequent repair will be randomised to: d) a standard anterior or posterior prolapse repair, e) a standard repair with a non-absorbable mesh inlay to support the stitches, or f) a new mesh repair using an introducer (mesh kit). This last option will only be available for women having a secondary operation for prolapse as it is thought that it is more invasive than the other options and so should be reserved for such women, because they have a higher risk of failure.
All women having prolapse operations will be eligible for our study. They will be given information about the study before they are admitted to hospital. After discussion with their gynaecologist, women will be able to choose whether or not they are willing to be randomised to one of the specified operations. Those women who do not wish to be randomised to a particular procedure but are happy for their outcomes to be monitored, will be examined and will complete the questionnaires in the same way as the randomised groups as part of a Comprehensive Cohort.

Women will have a routine gynaecological examination before surgery and they will complete questionnaires both before and after their operation. Further symptom questionnaires will also be filled in 6, 12 and 24 months later. The women will be examined and reviewed in outpatients at 4 to 6 months after surgery. Our primary outcome is the cure or improvement of prolapse symptoms, as reported by the women themselves.


Trial staff login · Public information

COVID-19 update
In response to COVID-19, the study team are working from home. We are continuing to keep in touch with the participants in the study. It may be that we are in touch with you by a different method than usual (for example we may telephone you to complete questionnaires, rather than send them by post). If you have any questions about the study, please get in touch on 01224 438161 (and leave a message) or email prospect@abdn.ac.uk.

You can also find information about COVID-19 from the NHS websites in England, Scotland, Wales and Northern Ireland.

There is also information about COVID-19 on the UK government website.

General Data Protection Regulation Participant Information
This notice is provided in compliance with the General Data Protection Regulation (GDPR). It relates to the use of personally identifiable information collected for the purposes of the PROSPECT study.

Background
PROSPECT was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme in 2009 to assess the clinical effectiveness (including safety) and cost-effectiveness of three treatment modalities [(1) synthetic non-absorbable mesh inlay; (2) biological graft; and (3) mesh kit] compared with standard repair in women with pelvic organ prolapse of the anterior or posterior vaginal walls. Women having their first operation was considered independently from those having a repeat procedure of the same compartment because different surgical options were considered appropriate for clinical reasons. Women who did not wish to be randomised, or were not suitable for randomisation, were still eligible to be followed-up using the same protocol as part of the Comprehensive Cohort.

This notice is designed to provide general information about what we do with the research data that we collect when it includes personally-identifiable information.

Who is responsible for the data we collect?
Under the GDPR, the 'data controller' is responsible for what happens to data which is collected. The 'Data controller' for PROSPECT is the University of Aberdeen. You can find out more about how we use your information by contacting the PROSPECT Co-Chief Investigators (Dr Fiona Reid or Dr Suzanne Breeman; prospect@abdn.ac.uk) or the Data Protection Officer at the University of Aberdeen (dpa@abdn.ac.uk) .

Personal data we collect about individuals
During the conduct of the PROSPECT study we collected personal identifying data about study participants, for example, name, postal address and NHS number. This information was only collected with a particular purpose in mind, for example, sending postal questionnaires to participants for the collection of data. Importantly, this information is only made available to specified individuals in the study research team on a 'need to know' basis. For example the members of the research team who carry out the data analysis are not given access to the identifying data.

How we use personal data
As a publicly-funded organisation, and to comply with article 6 (1)(e) and 9(2)(j) of the GDPR, we ensure that it is in the public interest when we use personally-identifiable information in our research. Health and care research should serve the public interest, which means that before we are able to access the personal identifiable information we have to demonstrate that our research serves the interests of society as a whole.

To ensure we carry out our research to the highest standards we comply with the UK Policy Framework for Health and Social Care Research and other regulatory requirements.

How long we keep personal data for
The PROSPECT study we will keep personal identifiable data for twenty-five years after the study has finished.

How we protect data
We ensure that we protect personal identifiable data in accordance with the Data Protection Act 2018. To do this we use 'technical measures' such as encryption and passwords to protect the individual datasets as well as the systems the datasets are held in. We also use 'operational measures' to protect the data, for example, by limiting the number of people who have access to the databases in which identifiable data is held.

Sharing identifiable data
Personal identifiable data which is collected and managed by the PROSPECT research team will not be shared with anyone else unless this is required as part of the conduct of the research. For example, we ‘link’ information collected in the PROSPECT study to information collected by the NHS central registers (in England this is NHS Digital and in Scotland this is the Information Services Division [ISD]) to identify when study participants are admitted to hospital for prolapse-related treatment. To do this we have to share the identifiable information. We also use the information to make contact with study participants when they have agreed to be followed up.

At the end of any study, anonymised data (from which individuals cannot be identified) may be shared with other research groups who are doing similar research. The data which is shared in these circumstances will not include any information to enable individuals to be identified. Any information shared will only be used for the purpose of health and care research, and will not be used to contact individuals or to affect their care. No automated decision making tools, includes profiling, will be used.

The rights of individuals
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. However, your participation in PROSPECT is voluntary and you can withdraw your consent at any time without giving a reason by contacting the research team at the University of Aberdeen (contact details below). If you do 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.

Complaints
The individuals whose data we hold have the right to complain. If you are one of those individuals and you wish to raise a complaint about how we have handled your personal data, you can contact the research team at the University of Aberdeen (contact details below). If you are not happy after that, you can contact our Data Protection Officer, dpa@abdn.ac.uk, who will investigate the matter.

If you are still not satisfied with their response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO) by post (Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF) or phone (0303 123 1113).

Contact us
If you would like to contact us directly for more information about how we use and protect data collected for the purposes of the PROSPECT study, you can contact the research team at the University of Aberdeen by post (Health Services research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD), phone (01224 438161) or email (prospect@abdn.ac.uk).



 
Health Services Research Unit, University of Aberdeen - www.abdn.ac.uk/hsru