Condition category
Not Applicable
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
26/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs P Winkler-Seinstra

ORCID ID

Contact details

University Medical Centre Utrecht
Wilhelmina Kinderziekenhuis
Department of Paediatrics
KE04.133.1
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4001
p.winkler@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR164

Study information

Scientific title

Acronym

SPIN UTI study

Study hypothesis

In meningomyelocele (MMC)-children treated with clean intermittent catheterisation (CIC), the incidences of significant bacteriuria and pyelonephritic episodes are only slightly smaller in the group of subjects treated with low dose chemoprophylaxis (LDCP) compared to the group without LDCP.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Meningomyelocele (MMC)

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Number of urinary tract infections
2. Number of pyelonephritic episodes

Secondary outcome measures

Changes in antibiotic resistance patterns in the cultured uropathogens.

Overall trial start date

21/02/2005

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Neuropathic bladder-sphincter dysfunction
2. CIC and use of LDCP for at least 6 months
3. Good possibilities for communication
4. Written informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. Urinary tract infection (UTI) or - pyelonephritis at inclusion
2. Fever of unknown origin (e causa ignota [ECI])
3. Other neurologic diseases
4. Other diseases like IDDM that can cause UTI

Recruitment start date

21/02/2005

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Research organisation

Funder name

Wilhelmina Research Fund (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22019031

Publication citations

  1. Results

    Zegers B, Uiterwaal C, Kimpen J, van Gool J, de Jong T, Winkler-Seinstra P, Houterman S, Verpoorten C, de Jong-de Vos van Steenwijk C, Antibiotic prophylaxis for urinary tract infections in children with spina bifida on intermittent catheterization., J. Urol., 2011, 186, 6, 2365-2370, doi: 10.1016/j.juro.2011.07.108.

Additional files

Editorial Notes