Reuse of Intermittent Urethral Catheters

Wellspect HealthCare39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Intermittent Urethral Catheterization

Interventions

LoFric cathetersDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

North Idaho Urology

Coeur d'Alene, Idaho, United States

University of Pennsylvania, Penn Urology

Philadelphia, Pennsylvania, United States

Froedtert Medical College and Specialty Clinic

Milwaukee, Wisconsin, United States

Royal Rehab

Ryde, New South Wales, Australia

Outcomes

Primary Outcomes

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).

Time frame: At Baseline (Visit 1)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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