Transobturator Urethral Sling Placement With an Autologous Rectus Facia
Primary Purpose
Stress Urinary Incontinence, Surgery--Complications
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mid-urethral sling placement using autologous rectus fascia
Mid-urethral sling placement using synthetic mesh
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach
Eligibility Criteria
Inclusion Criteria:
- female patients that underwent mid-urethral sling placement
Exclusion Criteria:
- active urinary infection
- neurologic disorders
- malignancies
- history of radiotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
autologous fascia
synthetic mesh
Arm Description
Patients who underwent a transobturator sling placement using autologous rectus fascia
Patients who underwent a transobturator sling placement using synthetic mesh
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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''
Full Information
NCT ID
NCT03949348
First Posted
May 13, 2019
Last Updated
August 23, 2021
Sponsor
Ankara Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03949348
Brief Title
Transobturator Urethral Sling Placement With an Autologous Rectus Facia
Official Title
Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Surgery--Complications
Keywords
midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients who undergo a transobturator sling placement using autologous rectus fascia
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous fascia
Arm Type
Active Comparator
Arm Description
Patients who underwent a transobturator sling placement using autologous rectus fascia
Arm Title
synthetic mesh
Arm Type
Active Comparator
Arm Description
Patients who underwent a transobturator sling placement using synthetic mesh
Intervention Type
Procedure
Intervention Name(s)
Mid-urethral sling placement using autologous rectus fascia
Intervention Description
Mid-urethral sling placement using autologous rectus fascia
Intervention Type
Procedure
Intervention Name(s)
Mid-urethral sling placement using synthetic mesh
Intervention Description
Mid-urethral sling placement using synthetic mesh
Primary Outcome Measure Information:
Title
ICIQ-SF
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment Benefit Scale
Description
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''
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Surgery for female stress urinary incontinence
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female patients that underwent mid-urethral sling placement
Exclusion Criteria:
active urinary infection
neurologic disorders
malignancies
history of radiotherapy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27036519
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.
Results Reference
result
PubMed Identifier
25444955
Citation
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.
Results Reference
result
Learn more about this trial
Transobturator Urethral Sling Placement With an Autologous Rectus Facia
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