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

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).

Study Overview

• Status: Completed
• Conditions: Bacteriuria, Intermittent Catheterization
• Intervention / Treatment: Device: Chlorhexidine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 413 45
    • Spinal Cord Injury Unit, Sahlgrenska University Hospital
  • Höör, Sweden
    • Spinal Cord Injury Unit, Skåne University Hospital
  • Linköping, Sweden
    • Spinal Cord Injury Unit, Linköping University Hospital
  • Umeå, Sweden, 90185
    • Neurocentrum, Neurorehab, Norrlands Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine	Device: Chlorhexidine; Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Lena Rutberg, MD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: ABC-0008