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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wellspect HealthCare
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT01782404
First received: January 30, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Bacteriuria, Intermittent Catheterization
Device: Chlorhexidine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine

Resource links provided by NLM:


Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Proportion of patients with bacteriuria <10^3 CFU/ml [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 22
Study Start Date: January 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorhexidine Device: Chlorhexidine
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782404

Contacts
Contact: Klara Thorsson +46313764000

Locations
Sweden
Spinal Cord Injury Unit, Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 413 45
Spinal Cord Injury Unit, Skåne University Hospital Recruiting
Höör, Sweden
Spinal Cord Injury Unit, Linköping University Hospital Recruiting
Linköping, Sweden
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Principal Investigator: Lena Rutberg, MD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT01782404     History of Changes
Other Study ID Numbers: ABC-0008
Study First Received: January 30, 2013
Last Updated: May 6, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 20, 2014