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

Primary Purpose

Bacteriuria, Intermittent Catheterization

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Chlorhexidine
Sponsored by
Wellspect HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteriuria, Intermittent Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spinal Cord Injury Unit, Sahlgrenska University Hospital
  • Spinal Cord Injury Unit, Skåne University Hospital
  • Spinal Cord Injury Unit, Linköping University Hospital
  • Neurocentrum, Neurorehab, Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chlorhexidine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2013
Last Updated
August 11, 2015
Sponsor
Wellspect HealthCare
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1. Study Identification

Unique Protocol Identification Number
NCT01782404
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wellspect HealthCare

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria, Intermittent Catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Chlorhexidine
Intervention Description
Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
Primary Outcome Measure Information:
Title
Proportion of patients with bacteriuria <10^3 CFU/ml
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Provision of informed consent Female or male spinal cord injured subject aged 18 years and over Bacteriuria of >10^5 CFU/mL of >1 bacterial species verified during screening visit 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) Ability to retain fluid in the bladder (approx. 120 ml) for at least 10 minutes, as judged by the investigator Exclusion Criteria Signs or symptoms of symptomatic UTI that requires treatment, as judged by the investigator. Ongoing antibiotic treatment Known anatomical pathology of the urinary tract that could compromise results, as judged by investigator Subject with severe catheterisation difficulties, as judged by investigator Known hypersensitivity to chlorhexidine Use of other instillation products Pregnancy Use of medications that may affect the bacterial culture in the urine and bladder (e.g. methenamine hippurate) Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) Previous enrolment or allocation of treatment in the present study. Simultaneous participation in another clinical study that may interfere with the present study. Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Rutberg, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spinal Cord Injury Unit, Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Spinal Cord Injury Unit, Skåne University Hospital
City
Höör
Country
Sweden
Facility Name
Spinal Cord Injury Unit, Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Neurocentrum, Neurorehab, Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
90185
Country
Sweden

12. IPD Sharing Statement

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

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