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To Evaluate the Use of Bioresorbable Tephaflex™ Sling for Stress Urinary Incontinence

NCT03673488 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2018-09-17

No results posted yet for this study

Summary

Urinary incontinence (UI) is a major public health issue affecting up to 25-50% of all women and has a detrimental impact on patient quality of life. Stress urinary incontinence (SUI) is the most common form of urinary incontinence and is defined as the leakage of urine, which occurs during physical activity of exertion or on sneezing or coughing. It has been reported that the prevalence of SUI is 25 to 45% of the female population. If pelvic floor exercises are not effective, mid-urethral slings (MUS) are widely used as a first-line surgical treatment. Subjective and objective cure rates of 91% and 85% respectively have been reported for retropubic midurethral slings.

Midurethral slings are commonly made of polypropylene (PP). Although the polypropylene products are effective and have relatively low rates of adverse events, the adverse events that do occur, like exposure and pain, have been related to the fact that a permanent synthetic mesh is implanted. Mesh-related complications are difficult to manage and may even involve partial or complete removal of the implant.

Clinically, there is a need to investigate whether mid-urethral sling surgery can be performed with a non-permanent mesh made from a resorbable biomaterial, as an alternative for PP. Non-permanent meshes may be associated with fewer complications and better quality of life. However, before non-permanent and permanent mesh procedures can be compared, there is a need to first establish the feasibility of using a mesh in a mid-urethral sling procedure.

The investigators hypothesize that a retropubic mid-urethral sling procedure to treat stress urinary incontinence, can be successfully performed using an implant made of poly-4-hydroxybutyrate (P4HB).

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

TephaFlex™ mid-urethral sling

The sling is made from P4HB material. It is placed in a similar technique to standard retropubic sling procedures, but will resorb over 18-24 months post surgery.

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Pelvic Floor Research Foundation of South Africa

    lead OTHER

Principal Investigators

  • Jan-Paul Roovers, MD · Pelvic Floor Research Foundation of South Africa

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • South Africa

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 NCT03673488 on ClinicalTrials.gov