Skip to main content
Clinical Trials/NCT03949348
NCT03949348
Completed
Not Applicable

Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.

Ankara Training and Research Hospital0 sites35 target enrollmentMay 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Ankara Training and Research Hospital
Enrollment
35
Primary Endpoint
ICIQ-SF
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.

Detailed Description

Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can affect quality of life. Some clinical trials reported that the lifetime risk of a woman undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the most common surgery performed for female SUI. This procedure has high efficacy and low perioperative morbidity. Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic Association), the safety and efficacy of surgery for SUI using mesh devices has been questioned by a community of patients and clinicians. After Food and Drug Administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in SUI. Recently, female patients in England formed the campaign group "Sling the Mesh" to protest the synthetic mesh. Several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. The autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction. The investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
January 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ankara Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Fatih Kilinc

Principal invastigator

Ankara Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • female patients that underwent mid-urethral sling placement

Exclusion Criteria

  • active urinary infection
  • neurologic disorders
  • malignancies
  • history of radiotherapy

Outcomes

Primary Outcomes

ICIQ-SF

Time Frame: 2 years

The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in women in research and clinical practice across the world. It is scored on a scale from 0-21; higher values represent worse outcomes. The ICIQ-UI Short Form provides a brief and robust measure to assess the impact of symptoms of incontinence on outcome.

Secondary Outcomes

  • Treatment Benefit Scale(2 years)

Similar Trials