Veranderingen in plaspatroon en kwaliteit van leven bij kinderen met plasproblemen die een behandeling met Botox krijgen.
- Conditions
- Dysfunctional voiding.
- Registration Number
- NL-OMON23220
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
• Male or female children aged 5-12 years
• Has therapy-refractory DV and the next step in treatment is BoNT-A injection
Exclusion Criteria
• Has anatomic abnormalities of the urinary tract
• Patients who have received additional treatment:
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PVR, defined as volume of residual urine in the bladder after voluntary voiding determined through ultrasound, after treatment at predetermined time points compared to baseline.
- Secondary Outcome Measures
Name Time Method Results after treatment compared to baseline determined at predetermined time points:<br /><br>• Incontinence episodes per day derived from the voiding diary <br /><br>• 24 hour frequency derived from the voiding diary <br /> <br>• Number of UTIs: clinical symptoms (pollakiuria, dysuria) combined with a positive dipstick for leucocytes or a positive urine culture<br /><br>• Peak flow in ml/s derived from uroflowmetry<br /><br>• Scores derived from the PINQ and Vancouver SSDES questionnaires<br /><br>• Duration of improvement of voiding pattern and quality of life