Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

NCT07762300 | Recruiting

• 1 other identifier: MS.2026.14.5
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain).

  Evaluation of local tissue complications and adverse events associated with the sling material.

  Assessed at 6 months postoperatively.

Secondary Outcomes (6)

• Objective cure rate

  Assessed at 6 months postoperatively.

• Subjective cure rate and patient satisfaction.

  Assessed at 6 months postoperatively.

• Impact on quality of life and female sexual function.

  Assessed at 6 months postoperatively

• Female sexual function measured by the Female Sexual Function Index (FSFI)

  Assessed at 6 months postoperatively

• Total Operative Time

  Intraoperative (from initial skin incision to final wound closure).

Study Arms (2)

Group A (Standard Synthetic TOT)

ACTIVE COMPARATOR

Patients undergo the standard outside-in transobturator tape procedure using a full synthetic polypropylene tape.

Procedure: Standard Synthetic Transobturator Tape (TOT)

Group B (Hybrid Sling)

EXPERIMENTAL

Patients undergo the hybrid sling procedure using a composite graft consisting of an autologous rectus fascia strip centrally sutured to polypropylene tape arms.

Procedure: Hybrid Transobturator Tape Sling

Interventions

Standard Synthetic Transobturator Tape (TOT) PROCEDURE

Outside-in transobturator tape procedure utilizing a full synthetic polypropylene tape positioned tension-free under the mid-urethra.

Group A (Standard Synthetic TOT)

Hybrid Transobturator Tape Sling PROCEDURE

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.

Group B (Hybrid Sling)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mahmoud Atef Abdel Aziz, MSc

CONTACT

+201555056932; atefmahmoud050@outlook.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)