MiniMo-trial.
Completed
- Conditions
- Stress urinary incontinenceMid-urethral slingMiniArcMonarcPost-operative painCost-effectiveness
- Registration Number
- NL-OMON29267
- Lead Sponsor
- Academic Medical CenterMeibergdreef 91105 AZ AmsterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 192
Inclusion Criteria
Female symptomatic stress urinary incontinence resulting from urethral hypermobility and/or ISD (intrinsic sphincter deficiency).
Exclusion Criteria
1. Subjects who have stage 2 or more genital prolaps, according to the ICS-classification;
2. Subjects who undergo surgery for recurrence of stress incontinence;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Efficacy as surgical correction of stress urinary incontinence;<br /><br>2. Post-operative pain.
- Secondary Outcome Measures
Name Time Method 1. Complications;<br /><br>2. Morbidity and post-operative recovery;<br /><br>3. The need for repeated stress-incontinence surgery or specialized physiotherapy;<br /><br>4. Pelvic floor function;<br /><br>5. Cost-effectiveness from a societal perspective.