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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2017-05-03

Brief Summary

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

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Detailed Description

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Conditions

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Intermittent Urethral Catheterization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Actreen Hydrolite Cath

a new hydrophilic coated catheter for Urinary Intermittent Catheterisation

Group Type EXPERIMENTAL

Actreen Hydrolite Cath

Intervention Type DEVICE

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

Interventions

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Actreen Hydrolite Cath

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No