Intermittent Urethral CatheterizationNCT02911051
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
A study testing Actreen Hydrolite Cath in people with Intermittent Urethral Catheterization, run by BBraun Medical SAS at 1 site in France.
Trial summary
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermittent Urethral Catheterization
- What is being tested?
- Actreen Hydrolite Cath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2016to 3 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
- Conditions
- Intermittent Urethral Catheterization
- Being tested
- Actreen Hydrolite Cath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actreen Hydrolite CathDevice
Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day
| Study group | Role | What they receive |
|---|---|---|
| Actreen Hydrolite Cath | Experimental | a new hydrophilic coated catheter for Urinary Intermittent Catheterisation Receives: Device: Actreen Hydrolite Cath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence
Measured: All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start2 Sep 2016
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Urethral CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chartier-Kastler Emmanuel, Principal investigator, Hôspital Raymond Poincaré - Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911051
- Sponsor's protocol ID
- OPM-G-H-1303
- Other IDs
- 2014-A01774-43-A
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
- ClinicalTrials.gov ID
- NCT02911051
- Acronym / sponsor ID
- OPM-G-H-1303
- Conditions
- Intermittent Urethral Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Actreen Hydrolite Cath | Experimental | Device: Actreen Hydrolite Catha new hydrophilic coated catheter for Urinary Intermittent Catheterisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actreen Hydrolite CathDepending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day | Device | Actreen Hydrolite Cath |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Intermittent Urethral Catheterization
Active, not recruiting
How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding
Urinary Retention, Urinary Tract Infection (Diagnosis)
Not yet recruiting
Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.
Prostatic Hyperplasia, Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chartier-Kastler Emmanuel principal investigator
Hôspital Raymond Poincaré - Garches
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actreen Hydrolite Cath in people with Intermittent Urethral Catheterization, run by BBraun Medical SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.