Analysis of the TrueClr external catheter’s effectiveness in emptying the bladder
| ISRCTN | ISRCTN78009485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78009485 |
| Secondary identifying numbers | CIV-23-04-042855 |
- Submission date
- 20/06/2023
- Registration date
- 28/06/2023
- Last edited
- 21/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The aim of this study is to determine the effectiveness of the TrueClr External Catheter at emptying the bladder, as well as patients’ and medical professionals’ satisfaction with the safety and comfort of the TrueClr.
Who can participate?
Men aged 18 years and over who may benefit from the use of a urinary catheter
What does the study involve?
The TrueClr catheter is used to empty the participant's bladder. The volume of urine collected is measured and patients’ and medical professionals’ satisfaction is assessed.
What are the possible benefits and risks of participating?
The benefit may include increased comfort and safety of emptying the bladder with the TrueClr over traditional catheter systems, whilst the risk entails the TrueClr’s failure to empty the bladder, thus requiring the subsequent use of a traditional catheter system.
Where is the study run from?
Urologcentrum Liljeholmen (Sweden)
When is the study starting and how long is it expected to run for?
April 2023 to October 2023
Who is funding the study?
Mareld Medical AB (Sweden)
Who is the main contact?
Oscar Larsson, oscar@mareldmedical.com
Contact information
Public
C/O Port 2, Södra Strandgatan 17
Marstrand
44266
Sweden
| Phone | +46 (0)768326260 |
|---|---|
| oscar@mareldmedical.com |
Scientific
Urologcentrum Liljeholmen
Liljeholmstorget 7
Stockholm
117 63
Sweden
| Phone | +46 (0)8 710 91 00 |
|---|---|
| tareq.alsaody@urologcentrum.se |
Principal Investigator
Urologcentrum Liljeholmen
Liljeholmstorget 7
Stockholm
117 63
Sweden
| Phone | +46 (0)8 710 91 00 |
|---|---|
| tareq.alsaody@urologcentrum.se |
Study information
| Study design | Single-center non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other therapist office |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | TrueClr Sweden pilot study 2023-01 |
| Study acronym | TrueClr Swe 2023-01 |
| Study objectives | Primary: Patients will prefer TrueClr’s active external design as a safer and more comfortable alternative to internal catheter systems. Secondary: Medical professionals will prefer TrueClr’s active external design as a safer and more comfortable alternative to internal catheter systems. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This clinical investigation does not require an ethical review since: 1. The clinical investigation is conducted to further assess, within the scope of its intended purpose, a device which already bears the CE mark and the investigation does not involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device, or if additional procedures aren’t invasive nor burdensome, a notification to the Swedish MPA needs to be submitted at least 30 days before the investigation is initiated, according to the provisions HSLF-FS 2021:32. 2. The entity responsible for the research (i.e. the principal investigator) has determined that the investigation is not subject to an ethical review. 3. Therefore, the clinical investigation will commence when at least 30 days have passed since the notification was confirmed by the Swedish Medical Products Agency. |
| Health condition(s) or problem(s) studied | Urology (urine retention) |
| Intervention | The TrueClr External Catheter will be applied to the penises of participating subjects, after which the aspirator will be activated to apply suction to the penis. The TrueClr will remain applied for 10-30 minutes, or until the bladder of the subject has been emptied. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | UR24 technology TrueClr M/M+ |
| Primary outcome measure | The TrueClr external catheters' efficacy in emptying the bladder will be measured by recording the volume of urine collected. Extracted urine volume is measured in mL after the intervention. |
| Secondary outcome measures | 1. Patient satisfaction levels with safety and comfort recorded on a Visual Analogue Scale, with levels ranging from 1-10 (1 being extremely unsatisfied and 10 being extremely satisfied), after the intervention 2. Medical professional satisfaction levels with safety and comfort recorded on a Visual Analogue Scale, with levels ranging from 1-10 (1 being extremely unsatisfied and 10 being extremely satisfied), after the intervention |
| Overall study start date | 27/04/2023 |
| Completion date | 12/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 25 |
| Key inclusion criteria | Male patients aged 18 years and over benefitting from the use of a urinary catheter |
| Key exclusion criteria | Urethral stricture or other conditions negating the efficacy of an external urinary catheter |
| Date of first enrolment | 20/06/2023 |
| Date of final enrolment | 20/09/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
117 63
Sweden
Sponsor information
Industry
C/O Port 2, Södra Strandgatan 17
Marstrand
44266
Sweden
| Phone | +46 (0)768326260 |
|---|---|
| oscar@mareldmedical.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study results are to be used for marketing and commercial interest, mainly in the Nordic countries as well as in the United States. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to patient confidentiality. |
Editorial Notes
21/06/2023: Study's existence confirmed by the Swedish Medicines Agency.
