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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: Wellspect HealthCare

Current Primary Outcome: Proportion of patients with bacteriuria <10^3 CFU/ml [ Time Frame: 7 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml) [ Time Frame: 7 days ]

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.


Original Secondary Outcome: Same as current

Information By: Wellspect HealthCare

Dates:
Date Received: January 30, 2013
Date Started: January 2013
Date Completion:
Last Updated: August 11, 2015
Last Verified: August 2015