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

NCT02407145 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 218

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Urinary Stress Incontinence
  • Urinary Incontinence,Stress

Interventions

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.

Sponsors & Collaborators

  • Kebomed UK

    collaborator UNKNOWN

  • Julie Dawson

    lead OTHER

Principal Investigators

  • Sambit Mukhopadhyay · Norfolk and Norwich University Hospital Trust

  • Edward P Morris · Norfolk and Norwich University Hospital Trust

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-02-01
Completion
2021-04-01

Countries

  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02407145 on ClinicalTrials.gov