Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
Sponsor
sarah mohamed hassan (Other)
Overall Status
Unknown status
CT.gov ID
NCT03473041
Collaborator
(none)
140
1
2
18
7.8
Study Details
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence
Anticipated Study Start Date
:
Mar 1, 2018
Anticipated Primary Completion Date
:
Sep 1, 2019
Anticipated Study Completion Date
:
Sep 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hybrid sling 70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling |
Procedure: Hybrid sling
sling formed of surgeon tailored autologous rectus sheath and polypropylene arms
|
| Active Comparator: TVT-O 70 patients with stress urinary incontinence treated with conventional TVT-O |
Procedure: TVT-O
midurethral transobturator vaginal tape
|
Outcome Measures
Primary Outcome Measures
- cure rate [1 year follow up]
negative cough stress test
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- stress urinary incontinence
Exclusion Criteria:
- previous surgery for stress incontinence
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr El Ainiy Hospital | Cairo | Egypt | 11562 |
Sponsors and Collaborators
- sarah mohamed hassan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
sarah mohamed hassan,
lecturer of obstetrics and gynecology,
Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT03473041
Other Study ID Numbers:
- 783
First Posted:
Mar 21, 2018
Last Update Posted:
Mar 21, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by sarah mohamed hassan,
lecturer of obstetrics and gynecology,
Kasr El Aini Hospital
Additional relevant MeSH terms: