Reuse of Intermittent Urethral Catheters

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

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Urethral Catheterization
• Intervention / Treatment: Device: LoFric catheters

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Ryde, New South Wales, Australia, 1680
      • Royal Rehab
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital Spinal Unit
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3162
      • Caulfield Hospital, Spinal Rehabilitation Unit
• United States
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • North Idaho Urology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Penn Urology
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Medical College and Specialty Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of catheters with bacterial contamination (Y/N)	Proportion of catheters with bacterial contamination verified by culturing/incubation and visual inspection by Scanning Electron Microscope (SEM).	At Baseline (Visit 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Bacterial quantification by incubation.	At Baseline (Visit 1)
Pathogen identification by incubation.	At Baseline (Visit 1)
Material properties and bacteria/particle/tissue visualization by SEM.	At Baseline (Visit 1)
Presence of reuse found in medical records, patient reported questionnaires and patient interviews.	At Baseline (Visit 1) and at 4 weeks (Visit 2)
Bacterial level in urine sample	At Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Bonne Lee, Dr, Prince of Wales Hospital, Randwick, Australia; Principal Investigator: Diane Newman, Professor, University of Pennsylvania, Philadelphia, US

Publications and helpful links

General Publications

• Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2014
• Primary Completion (Actual): February 17, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: LOF-0028