Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

NCT01143116 | Completed Results

• 1 other identifier: YA-ABC-0003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteriuria

Outcome Measures

Primary Outcomes (3)

• Total Bacteria Count Change From Baseline and After 24 Hours.

  Change from baseline (urine sample immediately before first catheterization with study product) and after 24 hours of intermittent catheterization with the randomised study catheter.

  Baseline and after 24 hours

• Total Bacteria Count Change From Baseline and After 48 Hours.

  Change from baseline (urine sample immediately before first catheterization with study product) and after 48 hours of intermittent catheterization. After the baseline sample the subject had 24 hours with study randomized catheter and then changed to 24 hours on non-study sterile intermittent catheterization.

  Baseline and after 48 hours

• Total Bacteria Count Change From Baseline and After 7-14 Days.

  Change from baseline and after 7-14 days. Change from baseline (urine sample immediately before first catheterization with study product) to after 7-14 days.

  Baseline and after 7-14 days

Secondary Outcomes (10)

• Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours

  After first catheterization with study product and after 12 hours

• Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours

  After first catheterization with study product and after 24 hours

• Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours

  After first catheterization with study product and after 12 hours

• Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours

  After first catheterization with study product and after 24 hours

• Urine Silver Concentration Change From Baseline to 24 Hours

  Baseline to 24 hours

Study Arms (2)

Catheter A

EXPERIMENTAL

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).

Device: Silver-nitrate coated catheter ("Catheter A")

Catheter B

EXPERIMENTAL

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).

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

Interventions

Silver-nitrate coated catheter ("Catheter A") DEVICE

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

Catheter A

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

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

Catheter B

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/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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

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

Oswestry, Shropshire, SY10 7AG, United Kingdom

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

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Wellspect Health Care

mace@wellspect.com

+46313763000

Study Officials

• Waigh El Masri, Mr

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study subjects, study personnel and laboratory conducting the cultivations and analyses were blinded to the investigational products. The products had the same packaging and visual appearance. The treatment code was never broken during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 14, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-05

Locations

GB (1)