Clinical trial NCT01782404: Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
Official title: Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteriuria, Intermittent Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Proportion of patients with bacteriuria <10^3 CFU/ml
timeFrame: 7 days
Secondary outcomes:
measure: Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)
timeFrame: 7 days
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Spinal Cord Injury Unit, Sahlgrenska University Hospital
city: Höör
country: Sweden
facility: Spinal Cord Injury Unit, Skåne University Hospital
city: Linköping
country: Sweden
facility: Spinal Cord Injury Unit, Linköping University Hospital
city: Umeå
country: Sweden
facility: Neurocentrum, Neurorehab, Norrlands Universitetssjukhus
Study officials:
affiliation: Sahlgrenska University Hospital
name: Lena Rutberg, MD
role: PRINCIPAL_INVESTIGATOR
References: