Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBenha University
About this trial
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.
Eligibility criteria
Qualifiers
Female patients suffering from genuine stress urinary incontinence.
Failed conservative management (pelvic floor exercises, medical therapy)
Written informed consent.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard Synthetic Transobturator Tape (TOT)
- Hybrid Transobturator Tape Sling
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov