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Veranderingen in plaspatroon en kwaliteit van leven bij kinderen met plasproblemen die een behandeling met Botox krijgen.


- candidate number18261
- NTR NumberNTR4665
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2014
- Secondary IDsOZBS62.14009 METC 2014-223
- Public TitleVeranderingen in plaspatroon en kwaliteit van leven bij kinderen met plasproblemen die een behandeling met Botox krijgen.
- Scientific TitleChange in voiding pattern and quality of life in children with dysfunctional voiding who receive BoNT-A treatment: a prospective study.
- ACRONYMChange in voiding pattern after BoNT-A
- hypothesisTo assess the change in voiding pattern and quality of life in children who receive BoNT-A treatment in a prospective setting.
- Healt Condition(s) or Problem(s) studiedDysfunctional voiding, Children
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2014
- planned closingdate1-aug-2016
- Target number of participants30
- InterventionsNot applicable: study is observational.
- Primary outcomePVR, 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 outcomeResults 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
- TimepointsBaseline, 2 weeks after baseline, week 0, week 2, week 6, 3 months, 6 months, 9 months, 12 months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs L.A. Hoen, 't
- CONTACT for SCIENTIFIC QUERIESDrs L.A. Hoen, 't
- Sponsor/Initiator Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryDysfunctional 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.
- Main changes (audit trail)
- RECORD2-jul-2014 - 1-aug-2014


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