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Background

Stress urinary incontinence (SUI) is a distressing condition of involuntary urinary leakage in response to everyday actions that occurs in more than 30 per cent of women. The surgical implantation of a sub-urethral mesh device made of polypropylene (PP) remains the gold-standard treatment for SUI.

Unfortunately, PP meshes have been responsible, in a proportion of patients, for an unacceptable incidence of chronic pain. These complications, when they occur, have a devastating impact on quality of life. The use of PP meshes as a treatment for SUI has been halted in some countries, including the UK.

Solution

Our innovative approach uses a multi-layer elastomeric polymer that has a history of use in long-term implantable medical devices and responds to dynamic pressure without fatigue. We have designed our material to mimic the architecture of patients' native tissues.

It shows similar viscoelastic properties as pelvic floor fascial tissue and we have demonstrated good preliminary biocompatibility in animal models.

Benefits

As a direct substitute for polypropylene meshes in tension-free vaginal tapes (TVTs), our new material provides an important update to the gold standard treatment. It integrates better with patients’ tissues and is better suited to the dynamic environment of the pelvic floor.

Specifically:

• our material has an improved elastic response to the dynamic distension arising from changes in pelvic floor pressures;
• this, together with the material’s biocompatibility, leads to a lower inflammatory response and reduced levels of fibrosis; and
• we are also developing designs for improving approaches to the insertion, adjustment and fixing of such devices.

Intellectual Property 

The European and US patents have been granted.