Transobturator Urethral Sling Placement With an Autologous Rectus Facia

Not Applicable

Completed

• Conditions: Surgery--Complications; Stress Urinary Incontinence
• Interventions: Procedure: Mid-urethral sling placement using synthetic mesh; Procedure: Mid-urethral sling placement using autologous rectus fascia

• Registration Number: NCT03949348
• Lead Sponsor: Ankara Training and Research Hospital

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.

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2019-01-01
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Completion: 2021-01-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• female patients that underwent mid-urethral sling placement

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
synthetic mesh	Mid-urethral sling placement using synthetic mesh	Patients who underwent a transobturator sling placement using synthetic mesh
autologous fascia	Mid-urethral sling placement using autologous rectus fascia	Patients who underwent a transobturator sling placement using autologous rectus fascia

Primary Outcome Measures

Name	Time	Method
ICIQ-SF	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 Outcome Measures

Name	Time	Method
Treatment Benefit Scale	2 years	TBS consists of four categories scored as 1 (greatly improved) or 2 (improved), considered as ''yes,'' or 3 (not changed) or 4 (worsened), which were considered as ''no''