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Urinary Tract Infactions in Patients with poor bladder emptying and who use 'Intermittent Catetheterisation' to self empty their bladder.


- candidate number14411
- NTR NumberNTR3862
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-feb-2013
- Secondary IDs43313 ABR
- Public TitleUrinary Tract Infactions in Patients with poor bladder emptying and who use 'Intermittent Catetheterisation' to self empty their bladder.
- Scientific TitleUrinary Tract Infections (UTI) in Patients Practicing Intermittent Catheterisation (CIC).
- ACRONYM
- hypothesisIn this observation study we hypothise an incidence of UTIs of 30% in the first year after starting CIC. Moreover we hypothise a marked reduction in quality of life and an increase in health care expensis in patients with UTI.
- Healt Condition(s) or Problem(s) studiedUrinary tract infections, Urinary retention, Cathetherisation
- Inclusion criteriaPatients needing CIC to empty their bladder properly (residu after voiding/retention) or needing CIC to prevent strictures of the urethra.
- Exclusion criteria1. Patients younger than 18 years;
2. Patients who are pregnant or get pregnant during the study;
3. Mentally-retarded and demented patients;
4. Patients starting with antibiotics precautionary longer than three days.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2013
- planned closingdate1-mei-2015
- Target number of participants384
- InterventionsN/A
- Primary outcomeThe incidence of UTI’s in patients in Martini General Hospital Groningen and intended other (Santeon) hospitals using CIC to empty their bladder.
- Secondary outcomeThe impact of an UTI on patients’quality of life and on illness related (economic) costs e.g. direct costs of treatment, amount of hospital visits, hospital recording, loss of productivity etc.
- Timepoints1. Baseline at whicht patients start CIC;
2. One month follow-up;
3. Three months follow-up;
4. Twelve months follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES H.J. Mulder
- CONTACT for SCIENTIFIC QUERIES H.J. Mulder
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital Groningen, Hollister Incorporated, Goodlife Pharma
- PublicationsN/A
- Brief summaryUTI’s are commonly seen in CIC patients. This can have great impact on patients and healthcare expenders. However treatment and prevention of UTIs in CIC patients are largely not evidence-based.
In this multicentre prospective cohort study we aim to establish a reliable incidence number for UTIs and gain insight in the impact on patients’ quality of life and on illness related (economic) costs e.g. direct costs of treatment, amount of hospital visits, hospital recording, loss of productivity etc.
- Main changes (audit trail)
- RECORD18-feb-2013 - 2-mrt-2013


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