ClinicalTrials.gg
RecruitingNCT07762300Updated Aug 13, 2026

Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

An interventional study of Standard Synthetic Transobturator Tape (TOT) and Hybrid Transobturator Tape Sling in Stress Urinary Incontinence (SUI), Transobturator Tape and Hybrid Sling, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 39 studies in Urinary Incontinence, Stress with a site in Egypt — 15 open to participants now, 19 under way, none of them phase 3. Urinary Incontinence, Stress · Egypt.

Planned enrollment
9th of 31
90 · median 60
Started
2026
with 5 others
No phase
23 of 39
11 open now
Primary completion
2027-03
later than 16 of 18 live
Registered
37th of 39
by date
Lead sponsor
3 of 39
Benha University

Among the 39 studies in Urinary Incontinence, Stress with a site in Egypt, this one is the 9th largest by planned enrollment of the 31 interventional ones that give a count, is one of 6 that started in 2026, is one of 23 with no phase, reaches primary completion later than 16 of the 18 other live ones, and was the 37th registered.

Urinary Incontinence, Stress

653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.

Browse Urinary Incontinence, Stress studies →

Open to participants now

15 of the 39 studies in Urinary Incontinence, Stress with a site in Egypt are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Stress Urinary Incontinence (SUI)
  • Transobturator Tape
  • Hybrid Sling
  • Female Sexual Function
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Group A (Standard Synthetic TOT)

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

    Procedure: Standard Synthetic Transobturator Tape (TOT)

  • Experimental
    Group B (Hybrid Sling)

    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

  • ProcedureStandard Synthetic Transobturator Tape (TOT)

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

  • ProcedureHybrid Transobturator Tape Sling

    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.

06

What researchers measure

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.

    Time frame: Assessed at 6 months postoperatively.

Secondary outcomes

  1. Objective cure rate

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

    Time frame: Assessed at 6 months postoperatively.

  2. 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.

    Time frame: Assessed at 6 months postoperatively.

  3. 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.

    Time frame: Assessed at 6 months postoperatively

  4. 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.

    Time frame: Assessed at 6 months postoperatively

  5. Total Operative Time

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

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

  6. Length of Postoperative Hospital Stay

    Duration of hospital stay following surgery, measured in days.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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.

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

Of 226 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 8 months is below that.

Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 13, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Mar 1, 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762300
Lead sponsor
Benha University
Responsible party
‪Mahmoud Atef‬ Abd El Aziz (Lecturer of Urology, Benha University) — Principal investigator
First posted
Aug 13, 2026
Start date
Jul 1, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Mahmoud Atef Abdel Aziz, MSc
Contact
atefmahmoud050@outlook.sa
+201555056932

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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