A trial comparing two different tapes used for surgical treatment of stress urinary incontinence.
Recruiting
- Conditions
- urinary stress incontinencemid urethral slingTVT-OAjust
- Registration Number
- NL-OMON20238
- Lead Sponsor
- niversity Medical center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 145
Inclusion Criteria
1. Predominant stress incontinence;
2. Stress incontinence is confirmed;
Exclusion Criteria
1. Postvoid residual volume > 100cc;
2. History of anti-incontinence surgery;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the immediate and postoperative pain (up to 6 weeks) after an Ajust® or TVT-O® procedure.
- Secondary Outcome Measures
Name Time Method Objective cure of the SUI at 6 and 12 months follow up:<br /><br>1. Subjective cure and improvement of the SUI at 6 and 12 months follow up;<br /><br>2. Complications after the procedures;<br /><br>3. De novo obstructive or irritative bladder symptoms;<br /><br>4. Time to return to normal daily activities/work.