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Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women

Urinary Stress Incontinence Clinical Trial

Official title:
Safety and Efficacy of Low-elasticity Polyvinylidene Fluoride (DynaMesh®-SIS Soft) Retropubic Tension Free Midurethral Sling in the Treatment of Stress Urinary Incontinence in Women

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of stress urinary incontinence in women. Women who are having a retropubic PVDF midurethral sling for urodynamic stress incontinence will be followed up for 24 months to address its efficacy and rate of complications.

Clinical Trial Description

This study is designed to evaluate the safety and efficacy of low elasticity polyvinylidene fluoride (DynaMesh®-SIS soft) retropubic tension-free midurethral slings in the treatment of stress urinary incontinence (SUI) in women. Stress urinary incontinence is a common problem, affecting large numbers of women. If conservative measures are ineffective then surgery is offered. Surgery involves a permanent mesh sling being placed, tension free beneath the midurethra. The standard retropubic tension-free vaginal tape (TVT) has been used since 1996 using a polypropylene mesh.(1) The use of permanent mesh in gynaecology has come under scrutiny due to significant complications for women.(2) This year the Medicines and Healthcare Products Regulatory Agency (MHRA), UK concluded that there is not enough evidence to withdraw mesh from clinical usage.(3) The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.(4) Each sling is individually woven and and has low elasticity meaning dimensions are maintained under tension, such as with coughing or straining. The technique of retropubic placement of the DynaMesh®SIS soft does not differ from current retropubic TVT placement. The hypothesis is that the low elasticity polyvinylidene fluoride midurethral sling is non-inferior in both safety and efficacy compared with the safety and efficacy of traditional polypropylene slings, as reported in current literature. There are eleven research centres in two countries, The United Kingdom and Ireland. The DynaMesh®SIS soft sling is currently in use in four of eleven of the research hospitals, Norwich (main research centre), Antrim and Belfast in the UK and in Munich in Germany. It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK and Wurzbug in Germany. Women with urodynamic stress incontinence who are already assigned to have this retropubic midurethral tape placed for treatment will be recruited prior to their procedure for ongoing follow up. Participants will complete standardised urinary incontinence and quality of life questionnaires prior to their procedure and at 3,6,12, 18 and 24 months by post. Clinical follow up will occur at 3 and 12 months post operatively and as required if any concerns. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02407145
Study type Observational
Source Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact
Status Completed
Phase
Start date March 2016
Completion date April 1, 2021
View Details
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