Status:
COMPLETED
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Lead Sponsor:
Wellspect HealthCare
Conditions:
Bacteriuria
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts...
Detailed Description
The study was designed as a prospective, randomized, double-blind, single-site study of 24 hours use of a silver coated antibacterial catheter, and 24 hours follow up, in subjects practicing intermitt...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Female/male aged 18 years and over
- Practicing intermittent catheterization at least 4 times daily for at least 6 weeks
- A minimum of 104 CFU of bacteriuria
Exclusion
- Ongoing, symptomatic UTI at enrollment
- Known urethral stricture
- Basic tumorous disease
- Previous prostate surgery
- Subjects known to be immunocompromised e.g. HIV or diabetes
- Treatment with antibiotics and/or intravesical antiseptics for the past 30 days before study start
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Pregnancy or breast feeding
- Previous enrolment or randomisation of treatment in the present study
- Participation in a clinical study that possibly might interfere with the present study, as deemed by the investigator
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01143116
Start Date
November 1 2010
End Date
May 1 2011
Last Update
May 3 2022
Active Locations (1)
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1
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry, Shropshire, United Kingdom, SY10 7AG