Hybrid Transobturator Tape Versus Conventional Synthetic Tape for Stress Urinary Incontinence

Benha University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Standard Synthetic Transobturator Tape (TOT)PROCEDURE

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

Hybrid Transobturator Tape SlingPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

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.

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.

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

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

Total Operative Time

Central Contacts

Mahmoud Atef Abdel Aziz, MSc

CONTACT

+201555056932 atefmahmoud050@outlook.sa

Data from ClinicalTrials.gov

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