Change in voiding pattern and quality of life in children with dysfunctional voiding who receive BoNT-A treatment: a prospective study.

Change in voiding pattern and quality of life in children with dysfunctional voiding who receive BoNT-A treatment: a prospective study. - Change in voiding pattern after BoNT-A

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40770

Enrollment

Registered

2014-06-11

Start date

2015-01-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysfunctional voiding urinary incontinence

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

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	—

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

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Countries

Netherlands

Outcome results