Back to resultsMidurethral Sling With Autologus Rectus Sheath
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
rectus sheath midurethral sling
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- stress incontinence
Exclusion Criteria:
- overactive bladder
Sites / Locations
- Kasr El Ainiy Hospital
Outcomes
Primary Outcome Measures
cure rate of stress incontinence
history and urodynamic study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03463863
Brief Title
Midurethral Sling With Autologus Rectus Sheath
Official Title
The Safety And Efficacy Of Autologus Rectus Sheath Fascia As A 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
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
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
assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling
Detailed Description
the rectus sheath is harvested in 5 cm length and 2 cm width , A 2cm width 8 cm length polypropolyine mesh is attached to the harvest rectus sheet sling on both side The procedure is carried with a similar technique to the outside in TOT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
rectus sheath midurethral sling
Primary Outcome Measure Information:
Title
cure rate of stress incontinence
Description
history and urodynamic study
Time Frame
one year after surgery
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 incontinence
Exclusion Criteria:
overactive bladder
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Midurethral Sling With Autologus Rectus Sheath
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