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NCT03463863 Clinical Trial

Midurethral Sling With Autologus Rectus Sheath

Stress Urinary Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03463863
Other study ID # 732222
Secondary ID
Status Completed
Phase Phase 3
First received March 7, 2018
Last updated March 15, 2018
Start date August 10, 2016
Est. completion date January 2018

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

assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- stress incontinence

Exclusion Criteria:

- overactive bladder

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• rectus sheath midurethral sling

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 of stress incontinence history and urodynamic study one year after surgery
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