Clinical trial NCT02407145: Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Stress Incontinence
Urinary Incontinence,Stress
Keywords: retropubic
midurethral sling
polyvinylidene fluoride
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Kebomed UK
First posted: 2015-04-02
Enrollment: 218
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting with urinary incontinence, presenting to the research centres through normal referral pathways

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.
timeFrame: 3 to 24 months
measure: The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.
timeFrame: 3 to 24 months
Secondary outcomes:
measure: Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.
timeFrame: 3 to 24 months
measure: 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.
timeFrame: 3 to 24 months
measure: 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.
timeFrame: 3-24 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Chirurgische Klinik
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Huntingdon
country: United Kingdom
facility: Hichingbooke Hospital
state: Cambridgeshire
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambrigeshire
city: Belfast
country: United Kingdom
facility: South Eastern Health and Social Care Trust
city: Kilmarnock
country: United Kingdom
facility: NHS Ayrshire & Arran
city: London
country: United Kingdom
facility: University College Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals Trust
city: Solihull
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation
Study officials:
affiliation: Norfolk and Norwich University Hospital Trust
name: Sambit Mukhopadhyay
role: PRINCIPAL_INVESTIGATOR
affiliation: Norfolk and Norwich University Hospital Trust
name: Edward P Morris
role: STUDY_CHAIR
References:
citation: 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.
citation: U.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011
citation: A summary of the evidence on the benefits and risks of vaginal mesh implants. October 2014. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
citation: 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.