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

NCT01782404 | Completed

• 1 other identifier: ABC-0008
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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).

Conditions

Bacteriuria, Intermittent Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  7 days

Study Arms (1)

Chlorhexidine

EXPERIMENTAL

Device: Chlorhexidine

Interventions

Chlorhexidine DEVICE

Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily

Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (4)

Spinal Cord Injury Unit, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Spinal Cord Injury Unit, Skåne University Hospital

Höör, Sweden

Location

Spinal Cord Injury Unit, Linköping University Hospital

Linköping, Sweden

Location

Neurocentrum, Neurorehab, Norrlands Universitetssjukhus

Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Bacteriuria

Condition Hierarchy (Ancestors)

Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lena Rutberg, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

SE (4)