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Reuse of Intermittent Urethral Catheters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 30, 2014
First Posted Date  ICMJE May 2, 2014
Last Update Posted Date October 12, 2017
Actual Study Start Date  ICMJE June 20, 2014
Actual Primary Completion Date February 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
Number/proportion of catheters with bacterial contamination (Y/N) [ Time Frame: At Baseline (Visit 1) ]
Number/proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).
Change History Complete list of historical versions of study NCT02129738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • Bacterial quantification by incubation. [ Time Frame: At Baseline (Visit 1) ]
  • Pathogen identification by incubation. [ Time Frame: At Baseline (Visit 1) ]
  • Material properties and bacteria/particle/tissue visualization by SEM. [ Time Frame: At Baseline (Visit 1) ]
  • 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) ]
  • Bacterial level in urine sample [ Time Frame: At Baseline and 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reuse of Intermittent Urethral Catheters
Official Title  ICMJE Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Intermittent Urethral Catheterization
Intervention  ICMJE Device: LoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
Study Arms  ICMJE Experimental: LoFric
LoFric catheters
Intervention: Device: LoFric catheters
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
40
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date February 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02129738
Other Study ID Numbers  ICMJE LOF-0028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wellspect HealthCare
Study Sponsor  ICMJE Wellspect HealthCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bonne Lee, Dr Prince of Wales Hospital, Randwick, Australia
Principal Investigator: Diane Newman, Professor University of Pennsylvania, Philadelphia, US
PRS Account Wellspect HealthCare
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP