Hybrid Transobturator Tape vs Standard Synthetic TOT for Stress Urinary Incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares two surgical options for stress urinary incontinence in women: a novel hybrid transobturator tape combining autologous fascia with mesh, and the conventional synthetic transobturator tape. Participants are randomized to receive one of the two procedures, and outcomes include safety, efficacy, and effects on female sexual function. The trial targets women who have not benefited from conservative treatments and meet specific health criteria, with follow-up to assess continence and any adverse events. It is conducted at Benha University Hospital under Benha University as lead sponsor.

Why it matters

Who can join: the full rules

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).

Where it's running

• Benha University Hospital
  Banhā, Qalyubia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Mahmoud Atef Abdel Aziz, MSc
• Email: atefmahmoud050@outlook.sa
• Phone: +201555056932

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.