TVT-O versus TVT-S Trial.
Completed
- Conditions
- 1. Urinary incontinence (NLD: urine incontinentie)<br /> 2. stress incontinence<br />3. prosthesis<br />4. implants<br />5. TVT<br />6. TVT-o<br />7. TOT<br />8. TVT-s.
- Registration Number
- NL-OMON23119
- Lead Sponsor
- Jan-Paul W.R. Roovers, MD, PhD , Academisch Medisch Centrum, Amsterdam, the NetherlandsPiet Hinoul, MD, Ziekenhuis Oost Limburg, Genk, Belgium
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Urodynamically proven urinary stress incontinence.
Exclusion Criteria
1. Stage 2 or more genital prolapse (ICS classification);
2. Recurrent stress-incontinence;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morbidity:<br /> <br>1. A questionnaire to assess activities of daily life;<br /><br>2. A visual analogue scale (VAS score) to assess the experienced pain.<br>
- Secondary Outcome Measures
Name Time Method 1. General specific quality of life: SF-36;<br /><br>2. Disease specific quality of life: Urogenital;<br /> <br>3. Distress Inventory (UDI);<br /><br>4. Anatomical result – POP-Q score;<br /><br>5. Bladder function: voiding diary and uroflowmetry;<br /><br>6. Urogenital interventions in the first year after stress incontinence surgery;<br /><br>7. Catheter use.<br>