NCT02129738

Reuse of Intermittent Urethral Catheters

Completed NA Last updated 12 October 2017

What this trial tests

NA trial testing LoFric catheters in Intermittent Urethral Catheterization in 39 participants. Completed in 23 March 2017.

Timeline

20 June 2014

Primary endpoint
17 February 2017

23 March 2017

Quick facts

Lead sponsor	Wellspect HealthCare
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	39
Start date	20 June 2014
Primary completion	17 February 2017
Estimated completion	23 March 2017
Sites	7 locations across United States, Australia

Drugs / interventions tested

• LoFric catheters

Conditions studied

• Intermittent Urethral Catheterization — all drugs for Intermittent Urethral Catheterization →

Sponsor

Wellspect HealthCare

Who can join

18 and older, any sex, with Intermittent Urethral Catheterization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life.
   Newman DK, New PW, Heriseanu R, Petronis S, et al · · 2020 · cited 28× · PMID 32172456 · DOI 10.1007/s11255-020-02435-9
2. Intermittent Catheters for Chronic Urinary Retention: A Health Technology Assessment.
   Health Quality Ontario . · · 2019 · cited 12× · PMID 30847008