Transobturator Urethral Sling Placement With an Autologous Rectus Facia

Ankara Training and Research Hospital

Status: Completed

Conditions: Stress Urinary Incontinence; Surgery--Complications

Treatments: Procedure: Mid-urethral sling placement using autologous rectus fascia; Procedure: Mid-urethral sling placement using synthetic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03949348

0635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients that underwent mid-urethral sling placement

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

35 participants in 2 patient groups

autologous fascia

Active Comparator group

Description:

Patients who underwent a transobturator sling placement using autologous rectus fascia

Treatment:

Procedure: Mid-urethral sling placement using autologous rectus fascia

synthetic mesh

Active Comparator group

Description:

Patients who underwent a transobturator sling placement using synthetic mesh

Treatment:

Procedure: Mid-urethral sling placement using synthetic mesh