Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
Bacteriuria
About this trial
This is an interventional treatment trial for Bacteriuria
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Catheter A
Catheter B
Catheterization with Catheter A, which releases silver ions into the urethra and urinary bladder upon catheterization,. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).
Catheterization with Catheter B, which releases both silver ions and degradable silver particles.. After activation in the wetting solution the coating retains water creating a smooth liquid surface around the catheter.The products are intended for single use. No additional lubricant were used. The subject will be treated with investigational products during 24 hours. During this period the subject will be catheterized with the study catheter at six occasions (every 4 hours).