Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

NCT ID: NCT01143116

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

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 antibacterial activity that will have an impact on bacteria quantity in the urine bladder among users of intermittent catheterization.

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 intermittent catheterization.

Twenty male and female subjects using intermittent catheterization, having a confirmed significant bacteriuria were included in the study.

Conditions

Bacteriuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Catheter A

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).

Group Type: EXPERIMENTAL

Silver-nitrate coated catheter ("Catheter A")

Intervention Type: DEVICE

Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.

Catheter B

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).

Group Type: EXPERIMENTAL

Degradable silver particle-coated catheter ("Catheter B")

Intervention Type: DEVICE

Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.

Interventions

Silver-nitrate coated catheter ("Catheter A")

Catheter A releases silver ions into the urethra and urinary bladder upon catheterization.

Intervention Type: DEVICE

Degradable silver particle-coated catheter ("Catheter B")

Catheter B releases both silver ions and degradable silver particles into the urethra and urinary bladder upon catheterization.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Waigh El Masri, Mr

Role: PRINCIPAL_INVESTIGATOR

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Locations

The Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Oswestry, Shropshire, United Kingdom

Countries

United Kingdom

Other Identifiers

YA-ABC-0003

Identifier Type: -

Identifier Source: org_study_id