Development of Core Outcome Sets for pelvic floor disorders
Research type
Research Study
Full title
Development of Core Outcome Sets for pelvic floor disorders
IRAS ID
266957
Contact name
Stergios Doumouchtsis
Contact email
Sponsor organisation
Epsom & St Helier University Hospitals NHS Trust
Clinicaltrials.gov Identifier
981, COMET Registration
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We will undertake a study which is part of a wider project for Core Outcome and Outcome Measure Sets development that includes:
- Performing systematic reviews on pelvic floor disorders for the selection of patient reported outcomes and patient reported outcome measures in pelvic floor disorders studies. We have already published the following:
https://www.ncbi.nlm.nih.gov/pubmed/30431183
https://www.ncbi.nlm.nih.gov/pubmed/30431183
https://www.ncbi.nlm.nih.gov/pubmed/31357257
https://www.ncbi.nlm.nih.gov/pubmed/30009461- Meta-syntheses (analyzing data across qualitative studies). We have recently finalised a meta-synthesis of qualitative studies on pelvic organ prolapse, which is currently under review. Ongoing work is carried out within our research group to complete meta-syntheses on stress urinary incontinence, childbirth pelvic floor trauma and overactive bladder.
- Patient interviews (will be part of the qualitative study). We aim to include at least 20 women with stress urinary incontinence, 20 with pelvic organ prolapse, 20 with childbirth pelvic floor trauma and 20 with overactive bladder.
All the project streams that were mentioned above are aiming to generate a long list of outcomes and outcome measures used in pelvic floor disorders studies and that are relevant to the patients. The outcomes and outcome measures will be merged into an inventory.
The inventory will inform the 2 rounds of Delpi survey, in oreder to finally reach consensus on specific outcomes and outcome measures that should be included in the final Core Outcome and Outcome Measure Sets for pelvic floor disorders.
REC name
West of Scotland REC 1
REC reference
20/WS/0050
Date of REC Opinion
6 Mar 2020
REC opinion
Unfavourable Opinion