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Completed

NCT Number: NCT02129738

Reuse of Intermittent Urethral Catheters

The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization. The study will collect re-used catheters from included patients and compare those to a control group with regard to bacterial contamination and mechanical properties. A four week prospective evaluation will follow where the patients will be given catheters intended for single-use.

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Key information

Conditions

Intermittent Urethral Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Rehab, Ryde, New South Wales, Australia

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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 and/or male aged 18 years and over
  • Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
  • Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
  • Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
  • Able to use catheters of size:

40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;

Exclusion criteria

  • Antibiotic treatment within 4 weeks prior study inclusion
  • Drug or alcohol abuse or other disease of addiction
  • Immunocompromising diseases or medications
  • Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
  • Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
  • Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
  • Previous enrollment in the present study
  • Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
  • Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare

Treatment and study plan

LoFric catheters

Device

LoFric single use catheters to be used 4-6 times daily for 4 weeks.

Primary outcomes

  1. Proportion of catheters with bacterial contamination (Y/N)

    Time frame: At Baseline (Visit 1)

    Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).

Secondary outcomes

  1. Bacterial quantification by incubation.

    Time frame: At Baseline (Visit 1)

  2. Pathogen identification by incubation.

    Time frame: At Baseline (Visit 1)

  3. Material properties and bacteria/particle/tissue visualization by SEM.

    Time frame: At Baseline (Visit 1)

  4. Presence of reuse found in medical records, patient reported questionnaires and patient interviews.

    Time frame: At Baseline (Visit 1) and at 4 weeks (Visit 2)

  5. Bacterial level in urine sample

    Time frame: At Baseline and 4 weeks

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study title

Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 2, 2014
Registry last updated
Oct 12, 2017

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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