Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

Hybrid Transobturator Tape Versus Conventional Synthetic Tape: A Randomized Controlled Trial Assessing Safety, Efficacy, and Female Sexual Function

Registry ID

NCT07762300

Source registry

NCT

Status

RECRUITING

Phase

NA

Study type

INTERVENTIONAL

Sponsor

Benha University

Enrollment

90

Start date

2026-07-01

Completion date

2027-03-01

Last update

2026-08-13

Conditions

• Stress Urinary Incontinence (SUI)
• Transobturator Tape
• Hybrid Sling
• Female Sexual Function

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.

Interventions

• PROCEDURE: Hybrid Transobturator Tape Sling
• PROCEDURE: Standard Synthetic Transobturator Tape (TOT)

Inclusion criteria

Inclusion Criteria: * Female patients suffering from genuine stress urinary incontinence. * Failed conservative management (pelvic floor exercises, medical therapy) * Written informed consent.

Exclusion criteria

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 outcomes

[{"measure":"Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain).","timeFrame":"Assessed at 6 months postoperatively."}]

Locations

• Benha University Hospital, Banhā, Egypt

Publications

• Reference 1: El-Gamal, O., Soliman, M., Tawfik, A., & Abdel Raheem, A. (2013). Use of autologous rectus fascia in a new transobturator hybrid sling for treatment of female stress urinary incontinence: A pilot study. Scandinavian Journal of Urology, 47(1), 57-62. Reference 2: Wang, H., Liu, J., Fang, K., Liu, J., Chen, T., Yang, T., & Shi, X. (2022). Transobturator tape, tension-free vaginal tape, and transvaginal tension-free vaginal tape-obturator for the treatment of female stress urinary incontinence: A systematic review and network meta-analysis. International Journal of Gynaecology and Obstetrics, 157(3), 527-535.

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