Low dose chemoprophylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catheterisation (CIC)
| ISRCTN | ISRCTN56278131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56278131 |
| Protocol serial number | NTR164 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | Wilhelmina Research Fund (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 16/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs P Winkler-Seinstra
Scientific
Scientific
University Medical Centre Utrecht
Wilhelmina Kinderziekenhuis
Department of Paediatrics, KE04.133.1
PO Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 250 4001 |
|---|---|
| p.winkler@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Low dose chemoprophylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catheterisation (CIC) |
| Study acronym | SPIN UTI study |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Meningomyelocele (MMC) |
| Intervention | The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Number of urinary tract infections |
| Key secondary outcome measure(s) |
Changes in antibiotic resistance patterns in the cultured uropathogens |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 170 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/02/2005 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | Yes | No | |
| Results article | results | 12/01/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2017: Publication reference added.
