Midurethral Sling With Autologus Rectus Sheath

Sponsor
sarah mohamed hassan (Other)
Overall Status
Completed
CT.gov ID
NCT03463863
Collaborator
(none)
70
1
16.7
4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: rectus sheath midurethral sling
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Aug 10, 2016
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2018

Outcome Measures

Primary Outcome Measures

  1. cure rate of stress incontinence [one year after surgery]

    history and urodynamic study

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • stress incontinence
Exclusion Criteria:
  • overactive bladder

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:
NCT03463863
Other Study ID Numbers:
  • 732222
First Posted:
Mar 13, 2018
Last Update Posted:
Mar 16, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2018