NCT02911051
Completed
N/A
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
BBraun Medical SAS1 site in 1 country22 target enrollmentSeptember 2, 2016
ConditionsIntermittent Urethral Catheterization
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intermittent Urethral Catheterization
- Sponsor
- BBraun Medical SAS
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
Investigators
Eligibility Criteria
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
Outcomes
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.
Study Sites (1)
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