Safety and efficacy of PVDF (DynaMesh®SIS soft) retropubic slings.
Research type
Research Study
Full 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.
IRAS ID
167499
Contact name
Sambit Mukhopadhyay
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 3 days
Research 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.
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 DynaMesh®-SIS soft sling is currently in use in four of eight of the research hospitals, Norwich, Antrim, Belfast and Munich. It will be introduced in London, Dublin, Cambridge and Huntingdon.
Women who are having a retropubic tape inserted for SUI and have never had an incontinence operation will be included. They will have bladder studies (urodynamics) prior. Participants will complete validated urinary incontinence and quality of life questionnaires prior to their procedure and 3, 6, 12, 18 and 24 months postoperatively. Clinical follow up will occur at 3 and 12 months postoperatively and as required if any concerns.
The study is funded by Kebomed UK.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0204
Date of REC Opinion
15 Jul 2015
REC opinion
Further Information Favourable Opinion