Transobturator Urethral Sling Placement With an Autologous Rectus Facia

NCT ID: NCT03949348

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2021-01-01

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.

Conditions

Stress Urinary Incontinence; Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

autologous fascia

Patients who underwent a transobturator sling placement using autologous rectus fascia

Group Type: ACTIVE_COMPARATOR

Mid-urethral sling placement using autologous rectus fascia

Intervention Type: PROCEDURE

Mid-urethral sling placement using autologous rectus fascia

synthetic mesh

Patients who underwent a transobturator sling placement using synthetic mesh

Group Type: ACTIVE_COMPARATOR

Mid-urethral sling placement using synthetic mesh

Intervention Type: PROCEDURE

Mid-urethral sling placement using synthetic mesh

Interventions

Mid-urethral sling placement using autologous rectus fascia

Mid-urethral sling placement using autologous rectus fascia

Intervention Type: PROCEDURE

Mid-urethral sling placement using synthetic mesh

Mid-urethral sling placement using synthetic mesh

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• female patients that underwent mid-urethral sling placement

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muhammet Fatih Kilinc

Principal invastigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Linder BJ, Elliott DS. Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes. Urology. 2016 Jul;93:55-9. doi: 10.1016/j.urology.2016.03.025. Epub 2016 Mar 29.

Reference Type: RESULT

PMID: 27036519 (View on PubMed)

Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015 Mar;193(3):991-6. doi: 10.1016/j.juro.2014.08.125. Epub 2014 Oct 19.

Reference Type: RESULT

PMID: 25444955 (View on PubMed)

Other Identifiers

0635

Identifier Type: -

Identifier Source: org_study_id