Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

NCT07762300 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Not applicable

Started

2026-07-01

Last updated

2026-08-13

Condition(s) studied

Stress Urinary Incontinence (SUI)Transobturator TapeHybrid SlingFemale Sexual Function

Investigational drug(s) / intervention(s)

Standard Synthetic Transobturator Tape (TOT)Hybrid Transobturator Tape Sling

Standard Synthetic Transobturator Tape (TOT): Outside-in transobturator tape procedure utilizing a full synthetic polypropylene tape positioned tension-free under the mid-urethra.

Hybrid Transobturator Tape Sling: Insertion of a composite graft (autologous rectus fascia strip harvested via a Pfannenstiel incision and sutured between polypropylene tape arms) positioned via the obturator foramen route with the biological tissue directly under the mid-urethra.

Study 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

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Female patients suffering from genuine stress urinary incontinence. * Failed conservative management (pelvic floor exercises, medical therapy) * Written informed consent. Exclusion Criteria: * Mixed urinary incontinence with predominant urge component. * High-grade pelvic organ prolapse (POP-Q Stage \>= II), which required surgical intervention. * Neurogenic bladder or voiding dysfunction (Post-void residual \> 100 ml). * Coagulopathy or active urinary tract infection. * Patients who underwent recent pelvic radiotherapy. * Previous incontinence surgery (recurrent cases).

Primary outcome measure(s)

Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain). — Assessed at 6 months postoperatively.
Evaluation of local tissue complications and adverse events associated with the sling material.

Trial sites (1)

Facility	City	Region	Status
Benha University Hospital	Banhā	Qalyubia Governorate	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762300 on ClinicalTrials.gov ↗ ← All trials in Egypt