Addition of home measurement of bladder pressure and access to an interactive website reduces unscheduled hospital visits due to bladder and kidney problems.
ID
Bron
Verkorte titel
Aandoening
Meningomyelocele
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Reduction in unscheduled hospital visits due to bladder and kidney problems.
Achtergrond van het onderzoek
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.
The combined treatment with anticholinergics (oral or intravesical) and clean intermittent catheterization (CIC) reduces long term loss of bladder and kidney function in children with bladder overactivity. The clinical results of the combination anticholinergics and CIC in general practice are lower than could be expected on basis of the results obtained in controlled studies due to decreasing patient compliance in the long term. Compliance is defined here as use of medication and application of CIC according to the prescribed dose and frequency. The application of feedback tools may improve patient compliance and thereby the clinical results obtained with the current treatment of these patients.
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.
This study is a controlled intervention study. The study population exists of
100 children with Meningomyelocele, who are randomized in 2 groups:
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.
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.
Doel van het onderzoek
Addition of home measurement of bladder pressure and access to an interactive website reduces unscheduled hospital visits due to bladder and kidney problems.
Onderzoeksopzet
Screen visit, year 1, year 2, and year 3.
Onderzoeksproduct en/of interventie
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.
Publiek
Room Na-1712
's-Gravendijkwal 230
D.J. Kok
Rotterdam 3015 CE
The Netherlands
010-704 36 90
d.kok@erasmusmc.nl
Wetenschappelijk
Room Na-1712
's-Gravendijkwal 230
D.J. Kok
Rotterdam 3015 CE
The Netherlands
010-704 36 90
d.kok@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Children 0-18 years
- Already treated at our center with CIC and anticholinergics or new patients at our center who need CIC and anticholinergic treatment
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3858 |
NTR-old | NTR4101 |
CCMO | NL42026.078.12 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON39539 |