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

Study Overview

• Status: Completed
• Conditions: Intermittent Urethral Catheterization
• Intervention / Treatment: Device: Actreen Hydrolite Cath

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Chartier-Kastler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actreen Hydrolite Cath; a new hydrophilic coated catheter for Urinary Intermittent Catheterisation	Device: Actreen Hydrolite Cath; Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: BBraun Medical SAS
• Investigators: Principal Investigator: Chartier-Kastler Emmanuel, Hôspital Raymond Poincaré - Garches

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2016
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OPM-G-H-1303; 2014-A01774-43-A (Other Identifier: French Health Autority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No