Clinical trial NCT02129738: Reuse of Intermittent Urethral Catheters
Official title: Is Reuse of Intermittent Urethral Catheters Safe and Preferred? A Prospective, Observational Study Evaluating Reuse of Catheters and Switch to Single-use.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Urethral Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2014-05-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of catheters with bacterial contamination (Y/N)
timeFrame: At Baseline (Visit 1)
Secondary outcomes:
measure: Bacterial quantification by incubation.
timeFrame: At Baseline (Visit 1)
measure: Pathogen identification by incubation.
timeFrame: At Baseline (Visit 1)
measure: Material properties and bacteria/particle/tissue visualization by SEM.
timeFrame: At Baseline (Visit 1)
measure: Presence of reuse found in medical records, patient reported questionnaires and patient interviews.
timeFrame: At Baseline (Visit 1) and at 4 weeks (Visit 2)
measure: Bacterial level in urine sample
timeFrame: At Baseline and 4 weeks
Other outcomes:
Locations:
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Philadelphia
country: United States
facility: University of Pennsylvania, Penn Urology
state: Pennsylvania
city: Milwaukee
country: United States
facility: Froedtert Medical College and Specialty Clinic
state: Wisconsin
city: Ryde
country: Australia
facility: Royal Rehab
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital Spinal Unit
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Caulfield Hospital, Spinal Rehabilitation Unit
state: Victoria
Study officials:
affiliation: Prince of Wales Hospital, Randwick, Australia
name: Bonne Lee, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania, Philadelphia, US
name: Diane Newman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.