No registrations found.
ID
Source
Brief title
Health condition
Dysfunctional voiding.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
Dysfunctional voiding (DV) is a term used for nonneurogenic increased urethral sphincter or pelvic floor muscle activity during voluntary voiding. The result is a lack of coordination between the detrusor muscle and the urethral sphincter. This results in either symptoms of urinary incontinence (UI), urinary tract infections (UTIs), or high post-void residual (PVR). A substantial group of children with DV, 10-40%, remains therapy-refractory. This group of children currently receives BoNT-A injections in the external urethral sphincter at Erasmus MC - Sophia as standard care. In a retrospective analysis performed by the investigators of the current protocol BoNT-A treatment has shown to be an effective and safe treatment option.
Children will receive BoNT-A treatment as standard care. Changes in voiding pattern and quality of life will be determined at predetermined time points based on uroflowmetry, dipstick analysis, PVR determination, voiding diaries, and questionnaires.
This patient group has an average of 6 outpatient visits per year as part of standard care. During the last study visit they will perform an extra uroflowmetry and keep a voiding diary for two days similar to the other five outpatient visits. Patients will be asked to fill out two questionnaires, which are not part of standard care, at seven time points. They are asked to keep a voiding diary for two days at seven time points, including for telephone contact. This is one extra time compared to standard care.
Study objective
To assess the change in voiding pattern and quality of life in children who receive BoNT-A treatment in a prospective setting.
Study design
Baseline, 2 weeks after baseline, week 0, week 2, week 6, 3 months, 6 months, 9 months, 12 months.
Intervention
Not applicable: study is observational.
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4530 |
| NTR-old | NTR4665 |
| Other | METC 2014-223 : OZBS62.14009 |