We aim to increase patient compliance by extending the existing treatment protocol of (oral or intravesical) anticholinergics plus application of CIC with the addition of bladder pressure measurement performed at home during CIC plus access to an…
ID
Source
Brief title
Condition
- Renal and urinary tract disorders congenital
- Spinal cord and nerve root disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in unscheduled hospital visits (due to bladder and kidney problems).
Secondary outcome
- Preservation of bladder and renal function and quelity of life.
- Patient compliance to medication and CIC.
- Incidence and severity of bladder dysfunction related symptoms (incontinence
and overactivity related discomfort).
- Time of detection and frequency of tethered cord or other new neurological
damage.
- Time of detection and frequency of urinary tract infection (UTI).
- Anticholinergic application form.
- Actual dose of medication, determined from the answers on the questionnaires
and answers on the specific question on use of medication in the webtool.
- Actual CIC frequency.
- Patient satisfaction with treatment.
- Workload treatment team.
- Visits to website (indicator for motivation).
Background summary
Children with neurogenic bladder/sphincter dysfunction (BSD) of which the main
diagnosis is myelomeningocele (MMC) need life-long treatment by a
multidisciplinary team to prevent loss of renal function, urinary tract
infection (UTI) and incontinence. Currently the standard approach is to prevent
high bladder pressure and bladder overactivity with anticholinergic drugs, to
empty the bladder by Clean Intermittent Catheterization (CIC) and, if this
option is available, to monitor urinary tract function with yearly video
urodynamic studies (VUDS). The medication is administered either oral or
intravesical. This approach has had some success but is still suboptimal.
Quality of life (QOL) is still reduced by incontinence, many patients are
plagued by recurring UTI's, and renal transplantation and even mortality are
still end-stages for MMC patients. In view of the serious consequences and the
life-long aspect of the disease there is a need to improve the treatment.
Study objective
We aim to increase patient compliance by extending the existing treatment
protocol of (oral or intravesical) anticholinergics plus application of CIC
with the addition of bladder pressure measurement performed at home during CIC
plus access to an interactive website that provides feedback on the individual
situation. This should improve the clinical results, the occurrence of
bladder/kidney problems, and the quality of life. Consequently it should reduce
the number of unscheduled hospital visits due to bladder and kidney problems.
Study design
Controlled intervention study.
Intervention
Group 1:
Standard treatment of oral or intravesical anticholinergics and CIC, yearly
visits to the outpatient clinic, and yearly quality of life questionnaire, and
urine volume twice a month, access to a website with general information on
their disease and its treatment. The choice of anticholinergic application form
is free.
Group 2:
Standard treatment of oral or intravesical anticholinergics and CIC, yearly
visits to the outpatient clinic, yearly quality of life questionnaire, and
measurement of bladder pressure at home by using an extended catheter placed
along a vertical ruler and urine volume twice a month. The patients (or
caregivers) enter the data on a secured website that provides them feedback on
their current situation and an overview of their historic situation. The
website is entered with a username and password. Patient name, patient number,
address, and the name of the treating doctor are not in the online database.
The choice of anticholinergic application form is free.
Study burden and risks
Burden to group 1 (control group):
- A 3 year participation in the study.
- Measurement of urine volume during the first catheterization of the day twice
a month.
- Filling out a questionnaire on quality of life once a year (4 total).
Burden to group 2 (test group):
- A 3 year participation in the study.
- Measurement of bladder pressure and urine volume during the first
catheterization twice a month and entering the data on the interactive website.
- Filling out a questionnaire on quality of life once a year (4 total).
Overall the burden and risks associated with participation are for both groups
considered to be minimal.
The study is group related as the study can only be performed in this patient
group.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Children 0-18 years
* Already treated at our centre with CIC and anticholinergics or new patients at our centre who need CIC and anticholinergic treatment
Exclusion criteria
* Non-neurogenic BSD (e.g. urethral valves)
* Neurogenic bladder after bladder augmentation
* Inability of patient/ caregivers to understand the instructions on how to perform CIC
* Inability of patient/ caregivers to understand the instructions on the home bladder pressure measurements
* Inability of patient/caregivers to understand the instructions on application of the anticholinergics intravesical
* Inability of patient/ caregivers to understand the instructions on the use of the website.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL42026.078.12 |
OMON | NL-OMON23230 |