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

NCT02407145 | Completed

• 1 other identifier: 2015O&G01M
• Study Type: observational
• Target: 218
• Locations: 2 countries
• Sites: 10

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.

Conditions

Urinary Stress Incontinence; Urinary Incontinence,Stress

Keywords

retropubic; midurethral sling; polyvinylidene fluoride

Outcome Measures

Primary Outcomes (2)

• The subjective cure rate of retropubic midurethral PVDF slings in treating stress urinary incontinence.

  3 to 24 months

• The rate of complications of retropubic midurethral PVDF slings, in particular mesh erosions.

  3 to 24 months

Secondary Outcomes (3)

• Changes in quality of life, with regards to urinary symptoms, following placement of a retropubic midurethral PVDF sling.

  3 to 24 months

• 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

• 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

Study Arms (1)

PVDF retropubic midurethral sling

Women with urodynamic stress urinary incontinence having a retropubic polyvinylidene fluoride midurethral sling (DynaMesh®-SIS soft).

Other: 24 month follow up of women with validated questionnaire

Interventions

24 month follow up of women with validated questionnaire OTHER

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.

PVDF retropubic midurethral sling

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting with urinary incontinence, presenting to the research centres through normal referral pathways

You may qualify if:

• 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

You may not qualify if:

• urodynamic studies negative for stress urinary incontinence
• previous incontinence procedures
• non English/non German speaker depending on study centre
• lack capacity to consent

Sponsors & Collaborators

• Julie Dawson: lead
• Kebomed UK: collaborator

Study Sites (10)

Chirurgische Klinik

Munich, 81679, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Hichingbooke Hospital

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, Cambrigeshire, CB2 0QQ, United Kingdom

Location

South Eastern Health and Social Care Trust

Belfast, BT16 1RH, United Kingdom

Location

NHS Ayrshire & Arran

Kilmarnock, KA2 0BE, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Wirral University Teaching Hospital NHS Foundation

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

Norfolk and Norwich University Hospitals Trust

Norwich, NR4 7UY, United Kingdom

Location

Heart of England NHS Foundation Trust

Solihull, B91 1PS, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 8798092 BACKGROUND

• U.S. FDA Safety Communication: urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. July 2011

  BACKGROUND

• A summary of the evidence on the benefits and risks of vaginal mesh implants. October 2014. Medicines and Healthcare Products Regulatory Agency, United Kingdom.

  BACKGROUND

• 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.

  PMID: 17488229 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sambit Mukhopadhyay

  Norfolk and Norwich University Hospital Trust

  PRINCIPAL INVESTIGATOR

• Edward P Morris

  Norfolk and Norwich University Hospital Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 2, 2015
• Study Start: March 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

GB (8); DE (2)