Reuse of Intermittent Urethral Catheters

Not Applicable

Completed

• Conditions: Intermittent Urethral Catheterization
• Interventions: Device: LoFric catheters

• Registration Number: NCT02129738
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Study Start: 2014-06-20
• Primary Completion: 2017-02-17
• Study Completion: 2017-03-23
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LoFric	LoFric catheters	LoFric catheters

Primary Outcome Measures

Name	Time	Method
Proportion of catheters with bacterial contamination (Y/N)	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

Name	Time	Method
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

Trial Locations

Locations (7)

University of Pennsylvania, Penn Urology; 🇺🇸 Philadelphia, Pennsylvania, United States

Prince of Wales Hospital Spinal Unit; 🇦🇺 Sydney, New South Wales, Australia

North Idaho Urology; 🇺🇸 Coeur d'Alene, Idaho, United States

Caulfield Hospital, Spinal Rehabilitation Unit; 🇦🇺 Melbourne, Victoria, Australia

Froedtert Medical College and Specialty Clinic; 🇺🇸 Milwaukee, Wisconsin, United States

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Royal Rehab; 🇦🇺 Ryde, New South Wales, Australia