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

Intermittent Urethral Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911051
• Other study ID #: OPM-G-H-1303
• Secondary ID: 2014-A01774-43-A
• Status: Completed
• Phase: N/A
• First received: September 20, 2016
• Last updated: January 23, 2018
• Start date: September 2, 2016
• Est. completion date: May 3, 2017

Study information

• Verified date: January 2018
• Source: BBraun Medical SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Urethral Catheterization

Intervention

Device:
• Actreen Hydrolite Cath
Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day

Locations

Country	Name	City	State
France	Chartier-Kastler	Garches

Sponsors (1)

Lead Sponsor	Collaborator
BBraun Medical SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.