No registrations found.
ID
Source
Brief title
Health condition
meningomyelocele
neuropathic bladder-sphincter dysfunction
spina bifida
urinary tract infections
Sponsors and support
dr. B Zegers, pediatrician, UMCU
dr. P. Dik, pediatric urologist, UMCU
dr. W. Feitz, pediatric urologist, UMCN
dr. R. de Gier, pediatric urologist, UMCN
Intervention
Outcome measures
Primary outcome
1. Number of urinary tract infections;
2. Number of pyelonephritic episodes.
Secondary outcome
Changes in antibiotic resistance patterns in the cultured uropathogens.
Background summary
170 children with MMC and CIC will be randomised with informed consent in two groups:
One with continuing LDCP and Second with LDCP stopped. Eligible subject will be recruited from the academic hositals in Utrecht and Nijmegen. Possibly also the academic hospitals in Leuven and Antwerp, Belgium will be involved. In all centers care and management of children with MMC know a long-standing team approach.
Recent ultrasound imaging of kidneys and bladder, as well as full urodynamic investigation results, will be available for each patient enrolled in the study and these baselines are repeated after the study. Over a period of 18 months a leucocyte esterase test (Combur 2) and a Uricult test (Uricult, Orion Diagnostica, Finland) are performed biweekly. Combined these tests have a high predictive value. All Uricult dipslides are sent to the laboratory of the treating hospital for incubation and, when positive, culturing to define the microorganism and its microbiologic properties.
Any occurence of fever is followed up and treated as a pyelonephritic episode.
After termination of the study a comparison of the incidences of significant bacteriuria and pyelonephritic episodes in the two groups is performed.
We expect that LDCP leads to a small decrease in the incidences of significant bacteriuria and pyelonephritic episodes, but induces UTI with more drug resistant microorganisms.
Study objective
In MMC-children treated with CIC, the incidences of significant bacteriuria and pyelonephritic episodes are only slightly smaller in the group of subjects treated with LDCP compared to the group without LDCP.
Intervention
The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.
Wilhelmina Children's Hospital,
Department of Pediatrics,
KE04.133.1,
P.O. Box 85090
P. Winkler-Seinstra
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
p.winkler@umcutrecht.nl
Wilhelmina Children's Hospital,
Department of Pediatrics,
KE04.133.1,
P.O. Box 85090
P. Winkler-Seinstra
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504001
p.winkler@umcutrecht.nl
Inclusion criteria
1. Neuropathic bladder-sphincter dysfunction;
2. CIC and use of LDCP for at least 6 months;
3. Good possibillities for communication;
4. Written informed consent.
Exclusion criteria
1. Urinary tract infection (UTI) or
- pyelonephritis at inclusion;
2. Fever e.c.i.;
3. Other neurologic diseases;
4. Other diseases like IDDM that can cause UTI.
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 | NL130 |
NTR-old | NTR164 |
Other | : N/A |
ISRCTN | ISRCTN56278131 |