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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Stress Incontinence; Urinary Incontinence,Stress
• Intervention / Treatment: Other: 24 month follow up of women with validated questionnaire

Detailed 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 Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81679
    • Chirurgische Klinik
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• United Kingdom
  • Belfast, United Kingdom, BT16 1RH
    • South Eastern Health and Social Care Trust
  • Kilmarnock, United Kingdom, KA2 0BE
    • NHS Ayrshire & Arran
  • London, United Kingdom, NW1 2BU
    • University College Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospitals Trust
  • Solihull, United Kingdom, B91 1PS
    • Heart of England Nhs Foundation Trust
  • Wirral, United Kingdom, CH49 5PE
    • Wirral University Teaching Hospital NHS Foundation
  • Cambridgeshire
    • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
      • Hichingbooke Hospital
  • Cambrigeshire
    • Cambridge, Cambrigeshire, United Kingdom, CB2 0QQ
      • Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women presenting with urinary incontinence, presenting to the research centres through normal referral pathways

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PVDF retropubic midurethral sling; Women with urodynamic stress urinary incontinence having a retropubic polyvinylidene fluoride midurethral sling (DynaMesh®-SIS soft).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.	3 to 24 months
The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.	3 to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.	3 to 24 months
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
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

Collaborators and Investigators

• Sponsor: Julie Dawson
• Collaborators: Kebomed UK
• Investigators: Principal Investigator: Sambit Mukhopadhyay, Norfolk and Norwich University Hospital Trust; Study Chair: Edward P Morris, Norfolk and Norwich University Hospital Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimated): April 2, 2015

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: retropubic; midurethral sling; polyvinylidene fluoride
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2015O&G01M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED