Transobturator Urethral Sling Placement With an Autologous Rectus Facia

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949348
• Other study ID #: 0635
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2021
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• female patients that underwent mid-urethral sling placement

Exclusion Criteria:

• active urinary infection

• neurologic disorders

• malignancies

• history of radiotherapy

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Surgery--Complications
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICIQ-SF	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.	2 years
Secondary	Treatment Benefit Scale	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''	2 years