Urinary CathetersNCT03289117
Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters
A study testing Novel gel installation device procedure and Standard procedure in people with Urinary Catheters and Retention, Urinary, run by Region Skane at 1 site in Sweden.
Trial summary
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urinary Catheters, Retention, Urinary, Incontinence, Urinary
- What is being tested?
- Novel gel installation device procedure and Standard procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 17 Apr 2016to 26 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
- The patient provides informed consent prior to any study specific procedures
- The patient is considered to benefit from participation in the clinical study
Who cannot join
- The patient do not consent to participate in the study
- Trauma to urethra or bladder
- Infection to urethra or bladder
- Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skåne University Hospital - Urology clinic - Homecare unit
Lund, 22185
About this study
Official title: Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
Read the detailed description
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).
- Being tested
- Novel gel installation device procedure, Standard procedure
- Keywords
- Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients
- Medical subject headings
- Urinary Retention, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel gel installation device procedureDevice
Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
Standard procedureDevice
Catheter change with standard procedure Each subject will undergo catheter change with standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Novel gel installation device procedure | Experimental | Catheter change with novel device.
Each subject will undergo catheter change with novel gel instillation device procedure Receives: Device: Novel gel installation device procedure |
| Standard procedure | Active comparator | Catheter change with standard procedure.
Each subject will undergo catheter change with standard procedure Receives: Device: Standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration (min)
Treatment duration for procedure
Measured: During procedure
Secondary outcomes (2)
Patient's perceived pain (NRS scale)
Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)
Measured: During intervention
Number of gel syringes used
Number of pre-filled gel syringes used during the procedure
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start17 Apr 2016
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CathetersStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device. Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Vinnova, Innovation Skåne AB/ Sweden
- Responsible party
- Sponsor
- Investigators
- Ulf Malmqvist, PhD, Principal investigator, Clinical Studies Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289117
- Sponsor's protocol ID
- 2016 02 01 ver 1_1
- Status last verified
- Oct 2017
- First submitted
- 18 Sep 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03289117
- Acronym / sponsor ID
- 2016 02 01 ver 1_1
- Keywords
- Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Vinnova, Innovation Skåne AB/ Sweden
- Study start
- 17 Apr 2016 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 20 Sep 2017 (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.
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
Detailed description
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device. Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
| Arm | Type | Receives |
|---|---|---|
| Novel gel installation device procedure | Experimental | Device: Novel gel installation device procedureCatheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure |
| Standard procedure | Active comparator | Device: Standard procedureCatheter change with standard procedure. Each subject will undergo catheter change with standard procedure |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
- The patient provides informed consent prior to any study specific procedures
- The patient is considered to benefit from participation in the clinical study
Key exclusion criteria (4 listed)
- The patient do not consent to participate in the study
- Trauma to urethra or bladder
- Infection to urethra or bladder
- Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician
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 |
|---|---|---|
| Novel gel installation device procedureCatheter change with novel device Each subject will undergo catheter change with novel gel instillation device | Device | Novel gel installation device procedure |
| Standard procedureCatheter change with standard procedure Each subject will undergo catheter change with standard procedure | Device | Standard procedure |
Primary outcome
Treatment duration (min)
Time frame: During procedure
Treatment duration for procedure
2 secondary outcomes
Patient's perceived pain (NRS scale)
Time frame: During intervention
Number of gel syringes used
Time frame: During intervention
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 20 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Ulf Malmqvist, PhD principal investigator
Clinical Studies Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel gel installation device procedure and Standard procedure in people with Urinary Catheters and Retention, Urinary, run by Region Skane at 1 site in Sweden.
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 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 20 Oct 2017. 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 Sweden. 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?
Treatment duration (min) (time frame: During procedure). 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 20 Oct 2017.