NCT03949348

Transobturator Urethral Sling Placement With an Autologous Rectus Facia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ankara Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence
• Surgery--Complications

Interventions

Type	Name	Description
PROCEDURE	Mid-urethral sling placement using autologous rectus fascia	Mid-urethral sling placement using autologous rectus fascia
PROCEDURE	Mid-urethral sling placement using synthetic mesh	Mid-urethral sling placement using synthetic mesh

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-01-01
• Completion: 2021-01-01
• First posted: 2019-05-14
• Last updated: 2021-08-26