Urethral Catheter; ComplicationsNCT06101121
Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
An observational study of Urethral Catheter; Complications, run by B. Braun Medical SA.
Trial summary
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice. Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urethral Catheter; Complications
- What is being tested?
- Lubri-Cream
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Oct 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See eligibility criteria
Who may be able to join
- Age ≥ 18 years
- Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
- Signed informed consent
Who cannot join
- Contraindications as stated in the Instructions for Use
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
- Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.
Trial locations and contacts
No sites are listed yet.
About this study
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.
Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.
Read the detailed description
The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers located in Spain will participate.
It is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. Safety and performance of Lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
- Conditions
- Urethral Catheter; Complications
- Being tested
- Lubri-Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubri-CreamDevice
Lubri-cream is indicated as a surface lubricant for bladder catheterization and cystoscopy. It will be slowly applied on the device, exerting gentle and constant pressure on the tube. Its contents will be evenly distrubuted from the tip to a suitable distance according to the technique to be performed. An individualized dose will be applied according to the technique to be performed and at the discretion of the healthcare professional
| Study group | Role | What they receive |
|---|---|---|
| Urethral catherisation | Observation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be 1 day when a bladder catheterization is undergone. Receives: Device: Lubri-Cream | |
| Cytoscopy | Observation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be the time which the catheterization lasts. Receives: Device: Lubri-Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
Patients' perception of pain level will be measured using the VAS, a visual scale of 10 cm in length, anchored by word descriptors at each end where "0 cm" means "no pain" and "10 cm" means "worst ever pain". The "zero-end" will be marked with "no pain" and the "10 cm"-end will be marked as "worst ever pain".
Measured: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)
Secondary outcomes (1)
Safety of Lubri-cream based on routinely measured clinical parameters
Occurrence of adverse events after its use in patients
Measured: During catheter insertion and catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Catheter; ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Maria Martínez, Dr., Principal investigator, Hospital Universitari Mútua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101121
- Sponsor's protocol ID
- HC-O-H-2113
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
- ClinicalTrials.gov ID
- NCT06101121
- Acronym / sponsor ID
- HC-O-H-2113
- Conditions
- Urethral Catheter; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- B. Braun Medical SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- 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 primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.
Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.
Detailed description
The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers located in Spain will participate.
It is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. Safety and performance of Lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urethral catherisation | – | Device: Lubri-CreamObservation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be 1 day when a bladder catheterization is undergone. |
| Cytoscopy | – | Device: Lubri-CreamObservation time will start with placement of catheter and will end with catheter removal or if any complication appears, whatever occurs first. In this case, the observational time will be the time which the catheterization lasts. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See eligibility criteria
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
- Signed informed consent
Key exclusion criteria (3 listed)
- Contraindications as stated in the Instructions for Use
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
- Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.
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 |
|---|---|---|
| Lubri-CreamLubri-cream is indicated as a surface lubricant for bladder catheterization and cystoscopy. It will be slowly applied on the device, exerting gentle and constant pressure on the tube. Its contents will be evenly distrubuted from the tip to a suitable distance according to the technique to be performed. An individualized dose will be applied according to the technique to be performed and at the discretion of the healthcare professional | Device | Cytoscopy, Urethral catherisation |
Primary outcome
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.
Time frame: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)
Patients' perception of pain level will be measured using the VAS, a visual scale of 10 cm in length, anchored by word descriptors at each end where "0 cm" means "no pain" and "10 cm" means "worst ever pain". The "zero-end" will be marked with "no pain" and the "10 cm"-end will be marked as "worst ever pain".
1 secondary outcome
Safety of Lubri-cream based on routinely measured clinical parameters
Time frame: During catheter insertion and catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Anna Maria Martínez, Dr. principal investigator
Hospital Universitari Mútua Terrassa
Questions about this trial
What is this clinical trial studying?
An observational study of Urethral Catheter; Complications, run by B. Braun Medical SA.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aina Fernández (+34 663 895 945, aina.fernandez@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Lubri-cream based on the pain minimization when patients undergo urethral catheterization and cystoscopy procedures. (time frame: During catheter insertion, catheter removal and if any complication appears (AE/SAEs)). 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 26 Oct 2023.