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Reuse of Intermittent Urethral Catheters

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ClinicalTrials.gov Identifier: NCT02129738
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intermittent Urethral Catheterization Device: LoFric catheters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
Actual Study Start Date : June 20, 2014
Actual Primary Completion Date : February 17, 2017
Actual Study Completion Date : March 23, 2017

Arm Intervention/treatment
Experimental: LoFric
LoFric catheters
Device: LoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129738


Locations
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United States, Idaho
North Idaho Urology
Coeur d'Alene, Idaho, United States, 83814
United States, Pennsylvania
University of Pennsylvania, Penn Urology
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Froedtert Medical College and Specialty Clinic
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Royal Rehab
Ryde, New South Wales, Australia, 1680
Prince of Wales Hospital Spinal Unit
Sydney, New South Wales, Australia, 2031
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Caulfield Hospital, Spinal Rehabilitation Unit
Melbourne, Victoria, Australia, 3162
Sponsors and Collaborators
Wellspect HealthCare
Investigators
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Principal Investigator: Bonne Lee, Dr Prince of Wales Hospital, Randwick, Australia
Principal Investigator: Diane Newman, Professor University of Pennsylvania, Philadelphia, US

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Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT02129738     History of Changes
Other Study ID Numbers: LOF-0028
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017