Midurethral Sling With Autologus Rectus Sheath

• Sponsor: sarah mohamed hassan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03463863
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 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
Stress Urinary Incontinence	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: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Mar 16, 2018