Change in voiding pattern and quality of life in children with dysfunctional voiding who receive BoNT-A treatment: a prospective study.
Completed
- Conditions
- Dysfunctional voidingurinary incontinence10004994
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
* Male or female children aged 5-12 years
* Has therapy-refractory DV and the next step in treatment is BoNT-A injection
* Has received a minimum of five sessions of urotherapy
* Has received a minimum of two sessions of pelvic floor muscle physical therapy
* Signed informed consent
Exclusion Criteria
* Has anatomic abnormalities of the urinary tract
* Patients who have received additional treatment:
o BoNT-A injections in the detrusor muscle
o Appendicovesicostomy
o Bladder augmentation
* Has a neurogenic disorder
* Has a neuromuscular disorder
* Has a psychological disorder
* Uses products that influence neuromuscular transmission
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PVR, defined as volume of residual urine in the bladder after voluntary voiding<br /><br>determined through ultrasound, after treatment at predetermined time points<br /><br>compared to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Results after treatment compared to baseline determined at predetermined time<br /><br>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<br /><br>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</p><br>