NCT02129738

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

April 30, 2014

Last Update Submit

October 11, 2017

Conditions

Intermittent Urethral Catheterization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

LoFric

EXPERIMENTAL

LoFric catheters

Device: LoFric catheters

Interventions

LoFric cathetersDEVICE

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

LoFric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

North Idaho Urology

Coeur d'Alene, Idaho, 83814, United States

Location

University of Pennsylvania, Penn Urology

Philadelphia, Pennsylvania, 19104, United States

Location

Froedtert Medical College and Specialty Clinic

Milwaukee, Wisconsin, 53226, United States

Location

Royal Rehab

Ryde, New South Wales, 1680, Australia

Location

Prince of Wales Hospital Spinal Unit

Sydney, New South Wales, 2031, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Caulfield Hospital, Spinal Rehabilitation Unit

Melbourne, Victoria, 3162, Australia

Location

Related Publications (1)

  • 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.

    PMID: 32172456DERIVED

Study Officials

  • Bonne Lee, Dr

    Prince of Wales Hospital, Randwick, Australia

    PRINCIPAL INVESTIGATOR

  • Diane Newman, Professor

    University of Pennsylvania, Philadelphia, US

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

June 20, 2014

Primary Completion

February 17, 2017

Study Completion

March 23, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

AU(4)US(3)