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

Not Applicable

Completed

• Conditions: Bacteriuria, Intermittent Catheterization
• Interventions: Device: Chlorhexidine

• Registration Number: NCT01782404
• Lead Sponsor: Wellspect HealthCare

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 Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorhexidine	Chlorhexidine	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with bacteriuria <10^3 CFU/ml	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.

Secondary Outcome Measures

Name	Time	Method
Time (number of days) to reduction of bacteriuria (<10^3 CFU/ml)	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.

Trial Locations

Locations (4)

Spinal Cord Injury Unit, Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Spinal Cord Injury Unit, Skåne University Hospital; 🇸🇪 Höör, Sweden

Neurocentrum, Neurorehab, Norrlands Universitetssjukhus; 🇸🇪 Umeå, Sweden

Spinal Cord Injury Unit, Linköping University Hospital; 🇸🇪 Linköping, Sweden