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 Details — Status: Completed

Administrative data

• NCT number: NCT02407145
• Other study ID #: 2015O&G01M
• Status: Completed
• Start date: March 2016
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2023
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: April 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• women with proven urodynamic stress incontinence in whom a retropubic midurethral sling is appropriate treatment as per the treating urogynaecologist, gynaecologist or urologist

• women who have not had a previous incontinence procedure

• no concomitant prolapse procedure at the time of sling placement

Exclusion Criteria:

• urodynamic studies negative for stress urinary incontinence

• previous incontinence procedures

• non English/non German speaker depending on study centre

• lack capacity to consent

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress
• Urinary Stress Incontinence

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Chirurgische Klinik	Munich
Germany	Universitätsklinikum Würzburg	Würzburg
United Kingdom	South Eastern Health and Social Care Trust	Belfast
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambrigeshire
United Kingdom	Hichingbooke Hospital	Huntingdon	Cambridgeshire
United Kingdom	NHS Ayrshire & Arran	Kilmarnock
United Kingdom	University College Hospital	London
United Kingdom	Norfolk and Norwich University Hospitals Trust	Norwich
United Kingdom	Heart of England NHS Foundation Trust	Solihull
United Kingdom	Wirral University Teaching Hospital NHS Foundation	Wirral

Sponsors (2)

Lead Sponsor	Collaborator
Julie Dawson	Kebomed UK

Countries where clinical trial is conducted

Germany,  United Kingdom, 

References & Publications (4)

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. — View Citation

U.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.		3 to 24 months
Primary	The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.		3 to 24 months
Secondary	Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.		3 to 24 months
Secondary	The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence compared to the reported cure rate for traditional polypropylene retropubic slings.		3 to 24 months
Secondary	The rate of complications of retropubic midurethral PVDF slings, in particular vaginal erosions and how the rates of complications compare to those reported in the literature for traditional polypropylene retropubic slings.		3-24 months