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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Transobturator Tape Versus Conventional Synthetic Tape: A Randomized Controlled Trial Assessing Safety, Efficacy, and Female Sexual Function
- ClinicalTrials.gov ID
- NCT07762300
- Acronym / sponsor ID
- MS.2026.14.5
- Conditions
- Stress Urinary Incontinence (SUI), Transobturator Tape, Hybrid Sling, Female Sexual Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Standard Synthetic TOT) | Active comparator | Procedure: Standard Synthetic Transobturator Tape (TOT)Patients undergo the standard outside-in transobturator tape procedure using a full synthetic polypropylene tape. |
| Group B (Hybrid Sling) | Experimental | Procedure: Hybrid Transobturator Tape SlingPatients undergo the hybrid sling procedure using a composite graft consisting of an autologous rectus fascia strip centrally sutured to polypropylene tape arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients suffering from genuine stress urinary incontinence.
- Failed conservative management (pelvic floor exercises, medical therapy)
- Written informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Synthetic Transobturator Tape (TOT)Outside-in transobturator tape procedure utilizing a full synthetic polypropylene tape positioned tension-free under the mid-urethra. | Procedure or surgery | Group A (Standard Synthetic TOT) |
| Hybrid Transobturator Tape SlingInsertion 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. | Procedure or surgery | Group B (Hybrid Sling) |
Primary outcome
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.
6 secondary outcomes
Objective cure rate
Time frame: Assessed at 6 months postoperatively.
Subjective cure rate and patient satisfaction.
Time frame: Assessed at 6 months postoperatively.
Impact on quality of life and female sexual function.
Time frame: Assessed at 6 months postoperatively
Female sexual function measured by the Female Sexual Function Index (FSFI)
Time frame: Assessed at 6 months postoperatively
Total Operative Time
Time frame: Intraoperative (from initial skin incision to final wound closure).
Length of Postoperative Hospital Stay
Time frame: Postoperative Day 1 through hospital discharge (up to 7 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- BackgroundReference 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Atef Abdel Aziz, MSc (+201555056932, atefmahmoud050@outlook.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain). (time frame: Assessed at 6 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.