Risk and decision making in the context of mesh procedures V1
Research type
Research Study
Full title
An investigation of the salient factors in decision-making relating to mesh procedures in a general urogynaecology surgical service.
IRAS ID
321253
Contact name
Joanna McParland
Contact email
Sponsor organisation
Glasgow Caledonian University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 17 days
Research summary
Pelvic organ prolapse (POP) is a common condition among women. POP occurs when 1 or more of the organs in the pelvis slip down from their normal position and bulge into the vagina, uterus, or both (Jelovsek et al., 2007; NHS, 2021). This condition has been shown to negatively impact the quality of life, daily activities, sexual function, and exercise of women (Jelovsek & Barber, 2006). One of the surgical options for POP treatment includes polypropylene mesh repair, used to support damaged or weakened biological tissue (Nüssler et al., 2018). Initially, mesh surgery was viewed as less invasive and more effective than traditional, non-mesh repairs (Morling et al., 2017). However, mesh surgery remains controversial. While mesh surgery may lower the reoccurrence of POP symptoms, there is also a risk of complications for some women (Maher et al., 2016; Mangir, 2020). Complications can include vaginal exposure of the mesh, erosion into the urinary tract or bowel, chronic pain, and infection (Barski et al., 2014; Cumberlege, 2020). In many countries there has been withdrawal or limited use of mesh surgery and increased concerns about complications, attracting widespread media attention (Izett et al., 2018). Given the risks associated with mesh surgery, it would be clinically valuable to explore the decision-making of people wishing to undergo a mesh procedure in a general urogynaecology service, looking at the information available to them and how they make use of this. Women who have decided whether or not to have mesh surgery for the treatment of POP will be eligible for this study. Eligible participants will be identified from outpatient clinics in urogynaecology in NHS Greater Glasgow and Clyde sites and waiting lists by an NHS clinical team. These participants will be invited to attend a 30–60-minute interview to discuss factors related to their decision-making.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0031
Date of REC Opinion
6 Feb 2023
REC opinion
Further Information Favourable Opinion