Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

Wellspect HealthCare

Status: Completed

Conditions: Bacteriuria, Intermittent Catheterization

Treatments: Device: Chlorhexidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01782404

ABC-0008

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Chlorhexidine

Experimental group

Treatment:

Device: Chlorhexidine