Intermittent Urethral Catheterization
Conditions
Brief summary
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
Interventions
DEVICEActreen Hydrolite Cath
Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day
Sponsors
BBraun Medical SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. male patient 2. patient is at least 18 years old 3. patient having normal or impaired sensation in the urethra 4. patient catheterizing at least 4 times a day 5. patient using Ch 12 or 14 catheter for self clean urinary catheterization 6. patient using a Nelaton catheter for self clean urinary catheterization 7. patient using self clean urinary catheterization for at least one month 8. patient covered with social insurance
Exclusion criteria
1. 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) 2. patient with urethral hypersensitivity 3. patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure 4. patient already participating in another clinical study or who have previously participated in this investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence | All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered. |
Countries
France
Outcome results
None listed