Bacteriuria, Intermittent Catheterization Clinical Trial
Official title:
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
| Verified date | August 2015 |
| Source | Wellspect HealthCare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
This a prospective, non-controlled, open, multi-center study evaluating the reduction of
bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with
chronic bacteriuria practicing intermittent catheterisation (IC). Patients will be treated
with chlorhexidine for bladder irrigation twice daily for a maximum of 7 days.
The study hypothesis is that bladder irrigation with chlorhexidine is efficient for a short
term reduction of bacteriuria in patients performing intermittent catheterization (IC).
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria 1. Provision of informed consent 2. Female or male spinal cord injured subject aged 18 years and over 3. Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit 4. Regular users of intermittent catheterisation as primary method for bladder management (defined as a normal catheterisation frequency of at least 3 times daily for at least 1 month) 5. Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator Exclusion Criteria 1. Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator. 2. Ongoing antibiotic treatment 3. Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator 4. Subject with severe catheterisation difficulties, as judged by investigator 5. Known hypersensitivity to chlorhexidine 6. Use of other instillation products 7. Pregnancy 8. Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate) 9. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) 10. Previous enrolment or allocation of treatment in the present study. 11. Simultaneous participation in another clinical study that may interfere with the present study. 12. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Spinal Cord Injury Unit, Sahlgrenska University Hospital | Göteborg | |
| Sweden | Spinal Cord Injury Unit, Skåne University Hospital | Höör | |
| Sweden | Spinal Cord Injury Unit, Linköping University Hospital | Linköping | |
| Sweden | Neurocentrum, Neurorehab, Norrlands Universitetssjukhus | Umeå |
| Lead Sponsor | Collaborator |
|---|---|
| Wellspect HealthCare |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with bacteriuria <10^3 CFU/ml | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The proportion of patients with at least one sample <10^3 CFU/ml within the 7 day treatment period will be evaluated. | 7 days | No |
| Secondary | Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) | Bacteriuria will be followed by daily urinary cultures, 3 hours after morning irrigation. The number of days until reduction of bacteriuria (<10^3 CFU/ml) will be evaluated. Maximum treatment period is 7 days. | 7 days | No |