Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

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Key information

Conditions

Intermittent Urethral Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chartier-Kastler

Garches, 92380, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male patient
patient is at least 18 years old
patient having normal or impaired sensation in the urethra
patient catheterizing at least 4 times a day
patient using Ch 12 or 14 catheter for self clean urinary catheterization
patient using a Nelaton catheter for self clean urinary catheterization
patient using self clean urinary catheterization for at least one month
patient covered with social insurance

Exclusion criteria

patient having a symptomatic urinary tract infection as assessed by the investigator (5 days after end of treatment for UTI, patient can be considered by the investigator for inclusion)
patient with urethral hypersensitivity
patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure
patient already participating in another clinical study or who have previously participated in this investigation

Treatment and study plan

Actreen Hydrolite Cath

Device

Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day

Primary outcomes

Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence

Time frame: All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered.

Sponsors and collaborators

Lead sponsor

BBraun Medical SAS

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 22, 2016
Registry last updated: Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed