Female stress urinary incontinence Urological and Genital Diseases Other disorders of urinary system
Conditions
Interventions
Surgical treatment: original inside-out transobturator tape (TVT-O™) versus a modification of the procedure, with no perforation of the obturator membrane and a shorter tape length. The procedure last
Sponsors
University Hospital of Sart Tilman (CHU de Sart Tilman) (Belgium)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age between 25 and 85 years 2. Clinical and urodynamic diagnoses of Stress Urinary Incontinence (SUI) 3. Positive stress test 4. Maximum cystometric capacity 300 ml or greater
Exclusion criteria
Exclusion criteria: 1. Urodynamically proven detrusor overactivity 2. Impaired bladder contractility 3. Post void residual (PVR) 100 ml or greater 4. Contraindication to anaesthesia 5. Pregnancy 6. Neurogenic bladder 7. Active urinary or vaginal infection 8. Concomitant symptomatic and/or significant (more than second degree) pelvic organ prolapse (POP) 9. Patient not willing or unable to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Objective and subjective cure of stress urinary incontinence at 1 year, measured by 1.1. Cough test (objective cure) 1.2. Measurement of Urinary Handicap (MUH), a validated self-administered questionnaire 2. Complication rates during a 1-year follow-up period, assessed by clinical examination and patient reporting at visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of postoperative pain at baseline, 1 day, 1, 6 and 12 months, measured by Visual Analogue Score (VAS) - inner thigh pain assessed for each side, left and right | — |
Countries
Belgium
Outcome results
None listed