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

Not Applicable

Completed

• Conditions: Intermittent Urethral Catheterization
• Interventions: Device: Actreen Hydrolite Cath

• Registration Number: NCT02911051
• Lead Sponsor: BBraun Medical SAS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-02
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Actreen Hydrolite Cath	Actreen Hydrolite Cath	a new hydrophilic coated catheter for Urinary Intermittent Catheterisation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chartier-Kastler; 🇫🇷 Garches, France