Comparison between the two transobturator inside-out procedures for the surgical treatment of female stress urinary incontinence: A randomised clinical trial
Completed
- Conditions
- Female stress urinary incontinenceUrological and Genital DiseasesOther disorders of urinary system
- Registration Number
- ISRCTN65635093
- Lead Sponsor
- niversity Hospital of Sart Tilman (CHU de Sart Tilman) (Belgium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 168
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Objective and subjective cure of stress urinary incontinence at 1 year, measured by<br>1.1. Cough test (objective cure) <br>1.2. Measurement of Urinary Handicap (MUH), a validated self-administered questionnaire<br>2. Complication rates during a 1-year follow-up period, assessed by clinical examination and patient reporting at visits
- Secondary Outcome Measures
Name Time Method 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