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

NCT ID: NCT01782404

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

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).

Conditions

Bacteriuria, Intermittent Catheterization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chlorhexidine

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DEVICE

Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

Interventions

Chlorhexidine

Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lena Rutberg, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Spinal Cord Injury Unit, Sahlgrenska University Hospital

Gothenburg, , Sweden

Spinal Cord Injury Unit, Skåne University Hospital

Höör, , Sweden

Spinal Cord Injury Unit, Linköping University Hospital

Linköping, , Sweden

Neurocentrum, Neurorehab, Norrlands Universitetssjukhus

Umeå, , Sweden

Countries

Sweden

Other Identifiers

ABC-0008

Identifier Type: -

Identifier Source: org_study_id