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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard Synthetic Transobturator Tape (TOT)
Procedure/SurgeryOutside-in transobturator tape procedure utilizing a full synthetic polypropylene tape positioned tension-free under the mid-urethra.
Hybrid Transobturator Tape Sling
Procedure/SurgeryInsertion 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Group A (Standard Synthetic TOT)Active comparator 1 intervention
Group B: Group B (Hybrid Sling)Experimental treatment 1 intervention
Trial outcomes
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 postoperatively4
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov