Female Sexual Function, Hybrid Sling, Stress Urinary Incontinence (SUI), Transobturator Tape
Conditions
Brief 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.
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mesh-related complications (including vaginal erosion, extrusion, and chronic groin pain). | Assessed at 6 months postoperatively. | Evaluation of local tissue complications and adverse events associated with the sling material. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective cure rate | Assessed at 6 months postoperatively. | Clinical confirmation of urinary continence via standardized cough stress testing and urodynamic assessments (uroflowmetry and cystometry). |
| Subjective cure rate and patient satisfaction. | Assessed at 6 months postoperatively. | 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. |
| Impact on quality of life and female sexual function. | Assessed at 6 months postoperatively | 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. |
| Female sexual function measured by the Female Sexual Function Index (FSFI) | Assessed at 6 months postoperatively | 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. |
| Total Operative Time | Intraoperative (from initial skin incision to final wound closure). | Total time required to complete the surgical procedure, measured in minutes. |
| Length of Postoperative Hospital Stay | Postoperative Day 1 through hospital discharge (up to 7 days). | Duration of hospital stay following surgery, measured in days. |
Countries
Egypt
Contacts
CONTACTMahmoud Atef Abdel Aziz, MSc
Outcome results
None listed