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NCT Number: NCT07762300

Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

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.

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Key information

Conditions

Stress Urinary Incontinence (SUI) Female Sexual Function Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hybrid Sling Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Transobturator Tape Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location status: Recruiting

Location contact

Mahmoud Atef Abdel Aziz, MSc

CONTACT

[email protected]

+201555056932

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard Synthetic Transobturator Tape (TOT)

Procedure

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

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.

Primary outcomes

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

    Time frame: Assessed at 6 months postoperatively.

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

Secondary outcomes

  1. Objective cure rate

    Time frame: Assessed at 6 months postoperatively.

    Clinical confirmation of urinary continence via standardized cough stress testing and urodynamic assessments (uroflowmetry and cystometry).

  2. Subjective cure rate and patient satisfaction.

    Time frame: Assessed at 6 months postoperatively.

    Measured using the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is a 7-point single-item questionnaire with scores ranging from 1 ("Very much better") to 7 ("Very much worse"). Lower scores indicate greater clinical improvement and higher patient satisfaction.

  3. Impact on quality of life and female sexual function.

    Time frame: Assessed at 6 months postoperatively

    Evaluated using validated questionnaires including the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Total scores range from 0 to 21, where higher scores indicate greater severity of incontinence and worse impact on quality of life.

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

    Time frame: Assessed at 6 months postoperatively

    Evaluated using the Female Sexual Function Index (FSFI), covering 6 domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Total full-scale scores range from 2.0 to 36.0, where higher scores indicate better sexual function.

  5. Total Operative Time

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

    Total time required to complete the surgical procedure, measured in minutes.

  6. Length of Postoperative Hospital Stay

    Time frame: Postoperative Day 1 through hospital discharge (up to 7 days).

    Duration of hospital stay following surgery, measured in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Atef Abdel Aziz, MSc

CONTACT

[email protected]

+201555056932

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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