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NCT03473041 Clinical Trial

Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

Stress Urinary Incontinence Clinical Trial

Official title:
Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03473041
Other study ID # 783
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 15, 2018
Last updated March 20, 2018
Start date March 2018
Est. completion date September 2019

Study information
Verified date March 2018
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 140
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- stress urinary incontinence

Exclusion Criteria:

- previous surgery for stress incontinence

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hybrid sling
sling formed of surgeon tailored autologous rectus sheath and polypropylene arms
• TVT-O
midurethral transobturator vaginal tape

Locations
Country Name City State
Egypt Kasr El Ainiy Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
sarah mohamed hassan

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary cure rate negative cough stress test 1 year follow up
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