Mesh study
Research type
Research Study
Full title
An observational study to determine the factors which increase the risk of long-term complications of polypropylene mesh tapes.
IRAS ID
273960
Contact name
Maya Basu
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Women who have had surgery using mesh tapes for incontinence are concerned about the development of complications. These include pain, exposure of mesh in the vagina and perforation of mesh into the bladder or urethra. Women want to know why these complications may develop. This study aims to assess if bacteria have contaminated the mesh at the time of initial surgery and how this may influence the body's response to the mesh. It also aims to compare these findings to the womens own microbiome to see if this influences the complications observed. The study will also assess how useful ultrasound may be at detecting mesh tape complications. All women with mesh complications will be eligible. There will be a control group of women who have had mesh without complications. The study will be conducted as part of the women's routine care. The control groups will be volunteers who attend for one research clinic appointment to have a scan, swabs and complete study questionnaires. The study will be conducted over 18 months.
REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0034
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion