Back to resultsAutologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
Primary Purpose
Stress Urinary Incontinence
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Hybrid sling
TVT-O
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring female stress incontinence, Transobturator tension free vaginal tape TVTO
Eligibility Criteria
Inclusion Criteria:
- stress urinary incontinence
Exclusion Criteria:
- previous surgery for stress incontinence
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hybrid sling
TVT-O
Arm Description
70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling
70 patients with stress urinary incontinence treated with conventional TVT-O
Outcomes
Primary Outcome Measures
cure rate
negative cough stress test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473041
Brief Title
Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
Official Title
Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
sarah mohamed hassan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)
Detailed Description
a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
female stress incontinence, Transobturator tension free vaginal tape TVTO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hybrid sling
Arm Type
Active Comparator
Arm Description
70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling
Arm Title
TVT-O
Arm Type
Active Comparator
Arm Description
70 patients with stress urinary incontinence treated with conventional TVT-O
Intervention Type
Procedure
Intervention Name(s)
Hybrid sling
Intervention Description
sling formed of surgeon tailored autologous rectus sheath and polypropylene arms
Intervention Type
Procedure
Intervention Name(s)
TVT-O
Intervention Description
midurethral transobturator vaginal tape
Primary Outcome Measure Information:
Title
cure rate
Description
negative cough stress test
Time Frame
1 year follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stress urinary incontinence
Exclusion Criteria:
previous surgery for stress incontinence
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
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