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Low dose chemoprofylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catherisation (CIC).

LDCP and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and CIC.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23169
Enrollment
170
Registered
2005-08-30
Start date
2005-02-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meningomyelocele neuropathic bladder-sphincter dysfunction spina bifida urinary tract infections

Interventions

The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.

Sponsors

Mrs. P. Winkler-Seinstra, research, UMCU dr. B Zegers, pediatrician, UMCU dr. P. Dik, pediatric urologist, UMCU dr. W. Feitz, pediatric urologist, UMCN dr. R. de Gier, pediatric urologist, UMCN
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
1. Number of urinary tract infections; 2. Number of pyelonephritic episodes.—

Secondary

MeasureTime frame
Changes in antibiotic resistance patterns in the cultured uropathogens.—

Contacts

Public ContactP. Winkler-Seinstra

University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital, Department of Pediatrics, KE04.133.1, P.O. Box 85090

p.winkler@umcutrecht.nl+31 (0)30 2504001

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)