Opsys bulking agent bij mannelijke incontinentie
Suspended
- Conditions
- mannelijk incontinentiebulking stofmale incontinencebulking agent
- Registration Number
- NL-OMON26801
- Lead Sponsor
- ot sponsored trialperformer ZGT and Jeroen Bosch Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Subject remains dry at night.
•Ability to voluntarily stop micturition.
Exclusion Criteria
•Post-prostatectomy radiotherapy or brachytherapy.
•Subject radiated as treatment of Prostate Cancer, being this interstitial or external, neo-adjuvant, therapeutic or adjuvant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is whether treatment was successful, based on the two 24 h pad weight test (PWT) before and after treatment. The success rate of the procedure will be assessed according to the following criteria presented in Table 2.<br><br /><br /><br>Table 2. Criteria for defining treatment success, improvement and failure.<br /><br>ResultCriteria<br /><br>EndpointActual valueEndpointActual value<br>SUCCESS24-h PWT0 -3 gORVoiding diary <br>(Count pads)0 pads<br /><br>IMPROVEMENT24-h PWT¡Ý 50% reductionORVoiding diary <br /><br>(Count pads)¡Ý 50% less usage of pads<br /><br>FAILUREUnable to meet the previous criteria<br><br>
- Secondary Outcome Measures
Name Time Method