Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008815

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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 eight research centres in three countries, The United Kingdom, Ireland and
Germany. The DynaMesh®SIS soft sling is currently in use in four of eight 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 and Huntingdon in the UK and Dublin in
Ireland.

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.

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Organizational Data

  •   DRKS00008815
  •   2015/08/11
  •   2015/03/24
  •   yes
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Secondary IDs

  •   NCT02407145  (ClinicalTrials.gov)
  •   2015O+G01M  ( (Norfolk and Norwich University Hospitals NHS Foundation Trust) )
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Health Condition or Problem studied

  •   Urinary Stress Incontinence
  •   Urinary Incontinence,Stress
  •   N39.3 -  Stress incontinence
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Interventions/Observational Groups

  •   Other: 24 month follow up of women with validated questionnaire
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Efficacy of retropubic midurethral PVDF slings assessed by subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence compared to the reported cure rate for traditional polypropylene retropubic slings.; time frame: 3 to 18 months

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Secondary Outcome

- Safety of retropubic midurethral PVDF slings assessed by the rate of complications of retropubic midurethral PVDF slings, in particular vaginal erosions, compared to those reported in the literature for traditional polypropylene retropubic slings; time frame: 3 to 18 months
- Quality of life assessed by changes in ICIQ-LUTS(qol) questionnaires over the study period; time frame: 3 to 18 months

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Countries of Recruitment

  •   Germany
  •   Ireland
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2015/08/31
  •   268
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   20   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Norfolk and Norwich University Hospitals NHS Foundation Trust
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    • Kebomed UK
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    • Norfolk and Norwich University Hospital Trust
    • Sambit Mukhopadhyay 
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    • Sambit Mukhopadhyay 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

  •   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.; 8798092
  •   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. Review.; 17488229
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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
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  • German director of clinical investigation 
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  • Further contact 
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.