Hybrid Transobturator Tape Versus Conventional Synthetic Tape: A Randomized Controlled Trial Assessing Safety, Efficacy, and Female Sexual Function
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized controlled trial compares the safety, efficacy, and impact on female sexual function of a novel hybrid transobturator tape (combining an autologous rectus fascia strip with a polypropylene mesh) versus standard synthetic transobturator tape in women undergoing surgery for stress urinary incontinence.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female patients suffering from genuine stress urinary incontinence.
• Failed conservative management (pelvic floor exercises, medical therapy)
• Written informed consent.
Locations
Other Locations
Egypt
Benha University Hospital
RECRUITING
Banhā
Contact Information
Primary
Mahmoud Atef Abdel Aziz, MSc
atefmahmoud050@outlook.sa
+201555056932
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 90
Treatments
Active_comparator: Group A (Standard Synthetic TOT)
Patients undergo the standard outside-in transobturator tape procedure using a full synthetic polypropylene tape.
Experimental: Group B (Hybrid Sling)
Patients undergo the hybrid sling procedure using a composite graft consisting of an autologous rectus fascia strip centrally sutured to polypropylene tape arms.
Related Therapeutic Areas
Sponsors
Leads: Benha University