Urinary Stress Incontinence Clinical Trial
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
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 |
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Julie Dawson | Kebomed UK |
Germany, United Kingdom,
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
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 |
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