Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
NCT ID: NCT02407145
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
218 participants
OBSERVATIONAL
2016-03-31
2021-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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PVDF retropubic midurethral sling
Women with urodynamic stress urinary incontinence having a retropubic polyvinylidene fluoride midurethral sling (DynaMesh®-SIS soft).
24 month follow up of women with validated questionnaire
24 month follow up (clinical and questionnaire based) of women who are already assigned to have a PVDF retropubic midurethral sling (DynaMesh®-SIS soft) as a part of their planned treatment of urodynamic stress incontinence.
Interventions
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24 month follow up of women with validated questionnaire
24 month follow up (clinical and questionnaire based) of women who are already assigned to have a PVDF retropubic midurethral sling (DynaMesh®-SIS soft) as a part of their planned treatment of urodynamic stress incontinence.
Eligibility Criteria
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Inclusion Criteria
* women who have not had a previous incontinence procedure
* no concomitant prolapse procedure at the time of sling placement
Exclusion Criteria
* previous incontinence procedures
* non English/non German speaker depending on study centre
* lack capacity to consent
20 Years
FEMALE
No
Sponsors
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Kebomed UK
UNKNOWN
Julie Dawson
OTHER
Responsible Party
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Julie Dawson
Research Services Manager
Principal Investigators
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Sambit Mukhopadhyay
Role: PRINCIPAL_INVESTIGATOR
Norfolk and Norwich University Hospital Trust
Edward P Morris
Role: STUDY_CHAIR
Norfolk and Norwich University Hospital Trust
Locations
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Chirurgische Klinik
Munich, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Hichingbooke Hospital
Huntingdon, Cambridgeshire, United Kingdom
Addenbrooke's Hospital
Cambridge, Cambrigeshire, United Kingdom
South Eastern Health and Social Care Trust
Belfast, , United Kingdom
NHS Ayrshire & Arran
Kilmarnock, , United Kingdom
University College Hospital
London, , United Kingdom
Wirral University Teaching Hospital NHS Foundation
Metropolitan Borough of Wirral, , United Kingdom
Norfolk and Norwich University Hospitals Trust
Norwich, , United Kingdom
Heart of England NHS Foundation Trust
Solihull, , United Kingdom
Countries
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References
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Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
U.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011
A summary of the evidence on the benefits and risks of vaginal mesh implants. October 2014. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
Klinge U, Binneboesel M, Kuschel S, Schuessler B. Demands and properties of alloplastic implants for the treatment of stress urinary incontinence. Expert Rev Med Devices. 2007 May;4(3):349-59. doi: 10.1586/17434440.4.3.349.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2015O&G01M
Identifier Type: -
Identifier Source: org_study_id