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Completed

NCT Number: NCT01143116

Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oswestry, Shropshire, SY10 7AG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver-nitrate coated catheter ("Catheter A")

Device

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

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Escherichia Coli Mean Bacteria Count Change From Baseline to 12 Hours

    Time frame: After first catheterization with study product and after 12 hours

    Escherichia coli mean bacteria count change from baseline (subjects with positive values) to after 12 hours.

    Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.

  2. Escherichia Coli Mean Bacteria Count Change From Baseline to 24 Hours

    Time frame: After first catheterization with study product and after 24 hours

    Escherichia coli mean bacteria count change from baseline (subjects with positive values).

    Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.

  3. Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 12 Hours

    Time frame: After first catheterization with study product and after 12 hours

    Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values).

    Baseline (urine sample immediately before first catheterization with study product) and then at 12 hours of study catheter use.

  4. Enterococcus Faecalis Mean Bacteria Count Change From Baseline to 24 Hours

    Time frame: After first catheterization with study product and after 24 hours

    Enterococcus faecalis mean bacteria count change from baseline (subjects with positive values).

    Baseline (urine sample immediately before first catheterization with study product) and then at 24 hours of study catheter use.

  5. Urine Silver Concentration Change From Baseline to 24 Hours

    Time frame: Baseline to 24 hours

    Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

    Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

  6. Urine Silver Concentration Change From Baseline and After 48 Hours

    Time frame: After first catheterization with study product and after 48 hours

    Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

    Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

  7. Urine Silver Concentration Change From Baseline to 7-14 Days

    Time frame: At baseline and after 7-14 days

    Urine silver concentration change from baseline excluding five subjects with extreme outlier values at baseline due to laboratory error during analysis and all subjects presented normal values during study follow up.

    Samples for analysis of silver concentration in urine were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

  8. Blood Silver Concentration Change From Baseline and After 24 Hours

    Time frame: After first catheterization with study product and after 24 hours

    Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

  9. Blood Silver Concentration Change From Baseline and After 48 Hours

    Time frame: After first catheterization with study product and after 48 hours

    Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

  10. Blood Silver Concentration Change From Baseline and After 7-14 Days

    Time frame: After first catheterization with study product and after 7-14 days

    Samples for analysis of silver concentration in blood were collected at baseline, after last catheterization with investigational product (at the very end of day 2) at the last catheterization at day 3 and at study termination (at 7-14 days).

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2010
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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