CompletedNot Applicable

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

France22 participantsStarted 2016-09-02

Plain-language summary

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

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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

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

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

NCT IDNCT02911051

SponsorBBraun Medical SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05-03