Urinary RetentionNCT05643950
Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention
A study testing Foley catheter in people with Urinary Retention and Catheter-Associated Urinary Tract Infection, run by Rethink Medical SL at 2 sites in Spain.
Trial summary
The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention. Read more about this study
- Who is it for?
- Ages 50 to 100 years, men only
- Conditions the study is for
- Urinary Retention, Catheter-Associated Urinary Tract Infection, Catheter Complications
- What is being tested?
- Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Aug 2023to Apr 2024
- 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 50 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with Acute Urine Retention
- Equal or over 50 years of age
- Absence of symptoms of infection on the inclusion day
- Not having been previously catheterized on the day of inclusion
- Indication of bladder catheterization for 2 weeks
- Maintained cognitive and physical capacity for self-monitoring the catheter valve
- Signed consent agreement
Who cannot join
- Current or recent urinary tract infection in the last 2 weeks
- Use of current treatment/antibiotic in the last 2 weeks
- Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
- Catheter insertion requiring more than 1 attempt
- Overactive bladder
- Patients with bilateral obstructive uropathy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
About this study
Official title: Evaluation of the Efficacy and Cost-effectiveness of the T-Control® Catheter Versus the Foley Type Catheter in Patients With Acute Urinary Retention. Randomized Controlled Pilot Clinical Trial
The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.
Read the detailed description
Potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. If the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. The catheter insertion will be carried out by the research staff after the inclusion and randomisation of the participants.
After catheter insertion, participants and their family, friends, or other informal caregivers will receive information about wearing an indwelling urinary catheter and specific information to randomly inserted, standard Foley, or T-Control® catheters. Standard catheter care is permitted during the trial both managed by the participants and participants' caregivers. Additionally, participants will receive an incident diary in which participants can record any type of incident during the bladder catheterisation period. Two weeks after indwelling bladder catheter insertion, participants will be contacted by urology outpatients for a follow-up visit, during which the study catheter will be removed.
Finally, within a maximum period of two weeks after the follow-up visit, the participants will be invited to participate in an interview to assess the quality of life perceived by the participants during the study
- Being tested
- Foley catheter, T-Control catheter
- Keywords
- Catheterisation, T-Control, Urinary catheter, Foley catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services.
For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.
T-Control catheterDevice
The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.
| Study group | Role | What they receive |
|---|---|---|
| Control arm (Foley catheter) | Active comparator | When randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter. Receives: Device: Foley catheter |
| T-Control arm | Experimental | When randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter. Receives: Device: T-Control catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of infections
The magnitude of infection will be obtained from the analysis of urine culture samples taken from participants
Measured: Day 14 after inclusion (follow-up visit)
Secondary outcomes (8)
Rate of symptomatic and asymptomatic infections
The magnitude of infection obtained from the urine samples will be classified according to the following criteria: Symptomatic infection: the presence of pathogenic microorganisms in amounts greater or equal to 1,000 CFU/mL accompanied with symptoms will determine the existence of the infection; Asymptomatic infection: in the absence of infection symptoms, a determination of microorganisms greater than or equal to 100,000 CFU/mL will indicate asymptomatic infection. In addition to the presence or absence of infections to assess their rate, this variable will also be collected using the outcome measure "infection-free days" (with a maximum possible value of 14 days).
Measured: Day 14 after inclusion (follow-up visit)
Self-perceived health-related quality of life (HRQoL)
The following instruments are administered to participants: EuroQol-5 Dimensions-5 Levels (this is a generic health-related quality of life questionnaire that evaluates five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questionnaire also includes a visual analogue scale) and a Catheter-related Quality of Life questionnaire (Rethink Medical developed a specific instrument created in the context of this project based on the experience of our previous studies. The questionnaire consists of questions that collect data on the prescription of the bladder catheter and on the accessories used (collection bag, plugs or others), questions related to acceptability, usability and satisfaction in relation to the catheter and the accessories used, adverse events and changes in habits in relation to the catheter and emotions perceived at the beginning and during the use of the bladder catheter).
Measured: Day 14 after inclusion (follow-up visit)
Indication of antibiotic treatments
The antibiotic that has been administered associated with the use of the catheter will be recorded along with the dose and treatment time.
Measured: Day 14 after inclusion (follow-up visit)
Determination of the biofilm formed in the catheters
The catheter removed will be sent to the laboratory and it will be cultured to assess the presence or absence of biofilm. The microorganisms forming the biofilm will be quantified as colony-forming units/catheter pieces. Also, these microorganisms will be identified in order to establish statistical relationships with those identified in the urine cultures.
Measured: Day 14 after inclusion (follow-up visit)
Number of adverse events related to catheterization
The type and number of adverse events will be recorded: accidental disconnection of the catheter, obstruction, pain, loss of urine per catheter, haematuria and accidental spills caused by the professional during the moment of insertion.
Measured: Day 14 after inclusion (follow-up visit)
Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants
The costs derived from the catheterization, such as the consumption of consumable materials and resources, diagnostic tests (urine cultures and catheter cultures and biofilm analysis) will be collected. The budgetary impact derived from the incorporation of T-Control® into the service portfolio of Spanish hospitals will be included. The main outcome measure will be the incremental cost per quality-adjusted life year (QALY) gained, a generic health measure that combines information on life expectancy with the patient's quality of life, the latter measured through the EuroQoL-5 Dimensions-5 Levels instrument. The perspective of the analysis will be that of the hospital, in which only direct healthcare costs will be included.
Measured: Close-out of the study
Level of satisfaction and workload of health professionals.
The following instruments are administered to health professionals: National Aeronautics and Space Administration - Task Load Index (The questionnaire evaluates 6 dimensions allowing to rate them on a 1 to 10 scale) and Health professional satisfaction questionnaire (questionnaire specifically developed to quantitatively measure satisfaction with the devices used. This questionnaire includes a first section with 12 statements regarding the catheter insertion process. The second section is intended for health professionals to make a comparison between both devices through 11 statements. Finally, the questionnaire consists of a free section in which health professionals can write any comments or suggestions).
Measured: Close-out of the study
Acceptability of the T-Control® device
Patient experience framed in the trajectory of the disease, identifying the preferences and needs for training and information for the use of the device and possible future improvements for the T-Control® device. A subgroup of participants will be selected by means of an intentional theoretical sampling seeking the maximum variability in terms of age and presence of infection. This selection will be made until information saturation is achieved, which is estimated between 10 and 20 participants. For data collection, the technique of in-depth interviews will be used using a semi-structured script. The interviews will be audio recorded and transcribed.
Measured: Day 14 after inclusion (follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Aug 2023
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Lack of patient recruitment by centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rethink Medical SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Vera, Dr., Principal investigator, Hospital Universitario Insular de Gran CanariaAdrián Amador, Dr., Principal investigator, University Hospital of the Nuestra Señora de Candelaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643950
- Sponsor's protocol ID
- RM-TCONTROL-2022-01
- Other IDs
- 2022-002862-34
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The requests for participant-level data and/or statistical code can be made in writing to info@rethinkmedical.es. The final trial dataset generated and/or analysed during the study may be available on reasonable request to the research coordinator and Sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Cost-effectiveness of the T-Control® Catheter Versus the Foley Type Catheter in Patients With Acute Urinary Retention. Randomized Controlled Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05643950
- Acronym / sponsor ID
- RM-TCONTROL-2022-01
- Keywords
- Catheterisation, T-Control, Urinary catheter, Foley catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient recruitment by centers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rethink Medical SLIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 9 Dec 2022 (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 general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.
Detailed description
Potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. If the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. The catheter insertion will be carried out by the research staff after the inclusion and randomisation of the participants.
After catheter insertion, participants and their family, friends, or other informal caregivers will receive information about wearing an indwelling urinary catheter and specific information to randomly inserted, standard Foley, or T-Control® catheters. Standard catheter care is permitted during the trial both managed by the participants and participants' caregivers. Additionally, participants will receive an incident diary in which participants can record any type of incident during the bladder catheterisation period. Two weeks after indwelling bladder catheter insertion, participants will be contacted by urology outpatients for a follow-up visit, during which the study catheter will be removed.
Finally, within a maximum period of two weeks after the follow-up visit, the participants will be invited to participate in an interview to assess the quality of life perceived by the participants during the study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm (Foley catheter) | Active comparator | Device: Foley catheterWhen randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter. |
| T-Control arm | Experimental | Device: T-Control catheterWhen randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males with Acute Urine Retention
- Equal or over 50 years of age
- Absence of symptoms of infection on the inclusion day
- Not having been previously catheterized on the day of inclusion
- Indication of bladder catheterization for 2 weeks
Key exclusion criteria (6 listed)
- Current or recent urinary tract infection in the last 2 weeks
- Use of current treatment/antibiotic in the last 2 weeks
- Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
- Catheter insertion requiring more than 1 attempt
- Overactive bladder
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 |
|---|---|---|
| Foley catheterSilicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services. For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use. | Device | Control arm (Foley catheter) |
| T-Control catheterThe T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter. | Device | T-Control arm |
Primary outcome
Magnitude of infections
Time frame: Day 14 after inclusion (follow-up visit)
The magnitude of infection will be obtained from the analysis of urine culture samples taken from participants
8 secondary outcomes
Rate of symptomatic and asymptomatic infections
Time frame: Day 14 after inclusion (follow-up visit)
Self-perceived health-related quality of life (HRQoL)
Time frame: Day 14 after inclusion (follow-up visit)
Indication of antibiotic treatments
Time frame: Day 14 after inclusion (follow-up visit)
Determination of the biofilm formed in the catheters
Time frame: Day 14 after inclusion (follow-up visit)
Number of adverse events related to catheterization
Time frame: Day 14 after inclusion (follow-up visit)
Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants
Time frame: Close-out of the study
Level of satisfaction and workload of health professionals.
Time frame: Close-out of the study
Acceptability of the T-Control® device
Time frame: Day 14 after inclusion (follow-up visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Yes. The requests for participant-level data and/or statistical code can be made in writing to info@rethinkmedical.es. The final trial dataset generated and/or analysed during the study may be available on reasonable request to the research coordinator and Sponsor.
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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.
Laura Vera, Dr. principal investigator
Hospital Universitario Insular de Gran Canaria
Adrián Amador, Dr. principal investigator
University Hospital of the Nuestra Señora de Candelaria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter in people with Urinary Retention and Catheter-Associated Urinary Tract Infection, run by Rethink Medical SL at 2 sites in Spain.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Magnitude of infections (time frame: Day 14 after inclusion (follow-up visit)). 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 27 Dec 2023.