Reuse of Intermittent Urethral Catheters

Intermittent Urethral Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129738
• Other study ID #: LOF-0028
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: October 11, 2017
• Start date: June 20, 2014
• Est. completion date: March 23, 2017

Study information

• Verified date: October 2017
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 23, 2017
• Est. primary completion date: February 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Urethral Catheterization

Intervention

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

Locations

Country	Name	City	State
Australia	Caulfield Hospital, Spinal Rehabilitation Unit	Melbourne	Victoria
Australia	Royal Rehab	Ryde	New South Wales
Australia	Prince of Wales Hospital Spinal Unit	Sydney	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Froedtert Medical College and Specialty Clinic	Milwaukee	Wisconsin
United States	University of Pennsylvania, Penn Urology	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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