Stress Urinary Incontinence (SUI)NCT07762300
Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence
A study testing Standard Synthetic Transobturator Tape (TOT) and Hybrid Transobturator Tape Sling in people with Stress Urinary Incontinence (SUI) and Transobturator Tape, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Transobturator Tape, Hybrid Sling
- What is being tested?
- Standard Synthetic Transobturator Tape (TOT) and Hybrid Transobturator Tape Sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients suffering from genuine stress urinary incontinence.
- Failed conservative management (pelvic floor exercises, medical therapy)
- Written informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Mahmoud Atef Abdel Aziz, MSc, +201555056932, atefmahmoud050@outlook.sa
About this study
Official title: Hybrid Transobturator Tape Versus Conventional Synthetic Tape: A Randomized Controlled Trial Assessing Safety, Efficacy, and Female Sexual Function
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
- Being tested
- Standard Synthetic Transobturator Tape (TOT), Hybrid Transobturator Tape Sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Synthetic Transobturator Tape (TOT)Procedure or surgery
Outside-in transobturator tape procedure utilizing a full synthetic polypropylene tape positioned tension-free under the mid-urethra.
Hybrid Transobturator Tape SlingProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Group A (Standard Synthetic TOT) | Active comparator | Patients undergo the standard outside-in transobturator tape procedure using a full synthetic polypropylene tape. Receives: 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. Receives: Procedure: Hybrid Transobturator Tape Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 6 months postoperatively.
Secondary outcomes (6)
Objective cure rate
Clinical confirmation of urinary continence via standardized cough stress testing and urodynamic assessments (uroflowmetry and cystometry).
Measured: Assessed at 6 months postoperatively.
Subjective cure rate and patient satisfaction.
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.
Measured: Assessed at 6 months postoperatively.
Impact on quality of life and female sexual function.
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.
Measured: Assessed at 6 months postoperatively
Female sexual function measured by the Female Sexual Function Index (FSFI)
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.
Measured: Assessed at 6 months postoperatively
Total Operative Time
Total time required to complete the surgical procedure, measured in minutes.
Measured: Intraoperative (from initial skin incision to final wound closure).
Length of Postoperative Hospital Stay
Duration of hospital stay following surgery, measured in days.
Measured: Postoperative Day 1 through hospital discharge (up to 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Atef Abd El Aziz, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762300
- Sponsor's protocol ID
- MS.2026.14.5
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared externally in order to maintain participant confidentiality and privacy in accordance with local institutional ethics board guidelines.
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.