Lab based model to test materials used to treat pelvic floor disorders
Research type
Research Study
Full title
A laboratory study to assess the failure mechanisms of materials used to treat pelvic floor disorders and to establish a predictable in vitro model for biocompatibility testing
IRAS ID
309968
Contact name
Victoria Workman
Contact email
Sponsor organisation
University of Sheffield
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Stress Urinary Incontinence and pelvic organ prolapse are very common conditions affecting the quality of life of thousands of women worldwide. The surgical implantation of a vaginal mesh is currently the best option to treat these disorders; however, very serious complications are associated to these products such as chronic pain, tissue damage and infection. Vaginal mesh products were introduced in the market without the relevant pre-clinical testing using hernia products as predicates. It was assumed that if these mesh implants worked well in one site of the body they would work equally well elsewhere.
For this project we want to develop an in vitro model to test the safety of these products. The model will allow us to understand some of the mechanisms by which these products fail leading to the clinical complications observed. This model will reduce the need for animal testing and could be used to predict post-implantation adverse outcomes for new and existing products.
A tissue engineered vaginal model will be produced in the lab from de-cellularised sheep vaginal tissues, wasted tissues obtained from an abattoir, which is re-seeded with lab expanded cells from human vaginal tissues. The model will allow us to assess simulated wound healing by introducing commercial devices and other new developed products within an incision made on the tissue engineered model. Acellular human dermis will be used as reference material for normal wound healing. Cadaveric dermis has been used for the surgical repair of the pelvic floor showing good biocompatibility without promoting a host response leading to clinical complications; however, low cure rates have been reported which is associated with rapid degradation of this biomaterial.
Surplus vaginal donated human tissue from surgery will provide an excellent, clinically relevant resource to perform this research, and to develop a model with potential to improve patient management.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
22/SW/0143
Date of REC Opinion
26 Sep 2022
REC opinion
Favourable Opinion