Dysfunctional voiding.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Results after treatment compared to baseline determined at predetermined time points: • Incontinence episodes per day derived from the voiding diary • 24 hour frequency derived from the voiding diary • Number of UTIs: clinical symptoms (pollakiuria, dysuria) combined with a positive dipstick for leucocytes or a positive urine culture • Peak flow in ml/s derived from uroflowmetry • Scores derived from the PINQ and Vancouver SSDES questionnaires • Duration of improvement of voiding pattern and quality of life | — |