Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02407145
Other study ID # 2015O&G01M
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02867748 - TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings N/A
Recruiting NCT02617797 - Radiofrequency in the Female Stress Urinary Incontinence N/A
Active, not recruiting NCT02538991 - TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence N/A
Completed NCT02480231 - Mid-Urethral Sling Tensioning Trial N/A
Terminated NCT02591381 - Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT00984958 - Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure N/A
Completed NCT00190567 - Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence Phase 2
Completed NCT02423486 - The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback N/A
Completed NCT01754558 - One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence N/A
Recruiting NCT00136071 - Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence N/A
Completed NCT00190619 - Efficacy and Safety of Duloxetine Phase 3
Completed NCT04288648 - Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Active, not recruiting NCT05182632 - Tele-rehabilitation Group Program for Urinary Incontinence in Older Women N/A
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT01784172 - Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial Phase 2
Recruiting NCT02935803 - A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients N/A
Active, not recruiting NCT02039830 - Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women N/A
Recruiting NCT04817839 - Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures N/A
Completed NCT03439527 - Multisystem Cell Therapy for Improvement of Urinary Continence Phase 1
Completed NCT01392651 - Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI N/A