To assess the change in voiding pattern and quality of life in children who receive BoNT-A treatment in a prospective setting.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
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.
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
A prospective observational cohort study.
Study burden and risks
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.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
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 |
|---|---|
| CCMO | NL48932.078.14 |