Transobturator Urethral Sling Placement With an Autologous Rectus Facia
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|ClinicalTrials.gov Identifier: NCT03949348|
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : August 26, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence Surgery--Complications||Procedure: Mid-urethral sling placement using autologous rectus fascia Procedure: Mid-urethral sling placement using synthetic mesh||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients who undergo a transobturator sling placement using autologous rectus fascia|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.|
|Actual Study Start Date :||May 1, 2016|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||January 1, 2021|
Active Comparator: autologous fascia
Patients who underwent a transobturator sling placement using autologous rectus fascia
Procedure: Mid-urethral sling placement using autologous rectus fascia
Mid-urethral sling placement using autologous rectus fascia
Active Comparator: synthetic mesh
Patients who underwent a transobturator sling placement using synthetic mesh
Procedure: Mid-urethral sling placement using synthetic mesh
Mid-urethral sling placement using synthetic mesh
- ICIQ-SF [ Time Frame: 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.
- Treatment Benefit Scale [ Time Frame: 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''
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Surgery for female stress urinary incontinence|
|Accepts Healthy Volunteers:||No|
- female patients that underwent mid-urethral sling placement
- active urinary infection
- neurologic disorders
- history of radiotherapy
|Responsible Party:||Muhammet Fatih Kilinc, Principal invastigator, Ankara Training and Research Hospital|
|Other Study ID Numbers:||
|First Posted:||May 14, 2019 Key Record Dates|
|Last Update Posted:||August 26, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
midurethral sling placement
autologous rectus fascia
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms