Pressure InjuriesNCT07093437
Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study
A study testing GRIP-LOK FOLEY SECUREMENT DEVICE ® and CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER in people with Pressure Injuries and Pain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pressure Injuries, Pain, Catheter-Associated Urinary Tract Infection
- What is being tested?
- GRIP-LOK FOLEY SECUREMENT DEVICE ® and CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Pacients with an urinary catheter inserted within the past 24 hours
- Expected duration of catheterization >48 hours
- Estimated ICU lenght os stay > 48 hours
Who cannot join
- Known allergy to adhesive tape
- Patients with lesions at the urinary meatus, ongoing urinary tract infection or suspected infection
- Presence of urological or prostatic pathology
- Any condition that prevents securing the urinary catheter to the thigh, such as wounds, burns, or amputations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institut de Recerca Sant Pau
Barcelona, 08024
Neus Calpe, PhD, MsN, RN, +34 680572768, ncalpe@santpau.cat
About this study
Official title: Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental
Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections .
The main questions the trial aims to answer are:
Read more
- Which device type better prevents injuries to the urethral meatus?
- Which device reduces discomfort for patients?
- Which device lowers the incidence of catheter-associated urinary tract infections?
Participants will:
- Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care
- Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter
- Provide feedback on their comfort and any complications experienced, if they are able to communicate
Read the detailed description
Urinary catheters (UC) are commonly used medical devices in Intensive Care Units (ICU), Between 50 % and 80 % of ICU patients have a UC in place. Although this is a relatively simple device, it is not free from risks, and complications associated with its use can be diverse and potentially serious.
Among the most relevant complications are three. First, catheter-associated urethral meatus injuries, which are lesions caused by continuous pressure from the catheter on surrounding tissues, affecting the glans, penis, or labia minora. The prevalence of these injuries in critically ill patients ranges between 13 % and 36 %. Secondly, pain and discomfort, occurring in approximately 47 % of UC users. Thirdly, catheter-associated urinary tract infection (CAUTI) is a frequent complication; in Spanish ICUs, it has accounted for 25 % to 30 % of all device-associated infections in recent years.
Securing urinay catheter to the leg is recommended by several international clinical practice guidelines (CPG) to prevent complications associated with UC use. In Spain, the national ITU ZERO initiative-led by the Ministry of Health and the Spanish Society of Intensive and Coronary Care Nursing-includes catheter securement as part of recommended care to reduce the risk of UC-related UTIs in critically ill patients.
Recent studies have evaluated the effectiveness of thigh securement of UC in ICU patients. One 2024 study showed that secured catheters significantly reduced the incidence of meatal injuries, decreased associated discomfort and lowered the risk of CAUTI.
Nowadays, two main types of commercial catheter securement devices are available: elastic wristband-style devices and adhesive-based devices. However, recent studies have not directly compared the effectiveness of these two types, and expert opinions vary.
Moreover, CPG recommend securement devices but do not specify which method is best for critically ill patients. This lack of clear guidelines and robust scientific evidence has resulted in low adherence to catheter securement practices among nurses. Prevalence studies from Canada and the UK (2016) reported low adherence rates. A recent qualitative study concluded that this low adherence stemmed from lack of training, ambiguous recommendations, limited scientific evidence, and insufficient engagement of nursing staff in care research.
In conclusion, urinary catheter securement in critically ill patients is a fundamental intervention for preventing complications, yet there remains a clear lack of comparative evidence between available devices, limiting professionals' ability to select the safest and most effective option. This knowledge gap justifies the need for research to determine which of the two securement types-adhesive or elastic-is more beneficial in this patient population.
________________________________________ Hypothesis: In critically ill patients, urinary catheter securement using adhesive devices is more effective than elastic wristband-style devices in preventing urethral meatus injuries, reducing discomfort, and decreasing the incidence of catheter-associated urinary tract infections.
It is proposed that adhesive devices provide greater stability and exert less pressure on tissues, thereby reducing iatrogenic complication risk and improving patient well-being, compared with elastic devices that may cause vascular compromise or skin irritation in edematous or fragile-skin patients.
This hypothesis will be tested by comparing both securement methods in terms of incidence of injuries, pain, and urinary tract infections in critically ill patients requiring long-term urinary catheters.
________________________________________ OBJECTIVES
Primary Objective:
To evaluate and compare the effectiveness of adhesive versus elastic wristband securement devices for urinary catheters in preventing catheter-associated complications in critically ill patients.
Secondary Objectives:
- Compare the effectiveness of adhesive versus elastic securement in preventing urethral meatus injuries in critically ill patients.
- Evaluate the effect of adhesive versus elastic securement on reducing discomfort and pain related to catheter use in critically ill patients able to communicate.
- Compare the incidence of catheter-associated urinary tract infections between groups using adhesive versus elastic securement devices.
- Analyze patient perceptions and experiences (in communicative patients) regarding the two types of securement devices.
- Identify and describe adverse events related to securement device use, such as catheter obstruction, skin lesions, and accidental catheter dislodgment.
METHODOLOGY This study will be conducted in the Intensive Care Unit (ICU) of Hospital de la Santa Creu i Sant Pau. It is an experimental, randomized, open-label trial with two intervention groups. Group 1 (G1) patients will receive urinary catheter securement using a commercially available adhesive device, while Group 2 (G2) patients will use an elastic wristband device. In this study, patients will be randomly assigned to G1 or to G2.
- Conditions
- Pressure Injuries, Pain, Catheter-Associated Urinary Tract Infection, Medical Device Site Injury
- Being tested
- GRIP-LOK FOLEY SECUREMENT DEVICE ®, CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER
- Keywords
- Urinary catheter securement, Urinary catheter fixation, Catheter-associated urinary tract infections, pain, Meatal pressure injuries
- Medical subject headings
- Pressure Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRIP-LOK FOLEY SECUREMENT DEVICE ®Device
- Used device: adhesive
- Specific Skin protection: with non alcohol barrier film
CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETERDevice
The elastic wristband will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.
| Study group | Role | What they receive |
|---|---|---|
| Urinary catheter securement with adhesive device | Experimental | * Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be chosen with the patient's leg bent, to ensure that the securement allows for future leg movement without causing tension or pulling on the catheter.
* Catheter anchoring method: In female patients, the catheter will be anchored at the "Y" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.
* Skin protection: Before applying the adhesive, a protective barrier spray (Cavilon® spray, 3M) will be applied to the selected skin area to prevent potential skin injury
* Application: The device will be applied following the manufacturer's instructions.
* Replacement: The device will be changed every 72 hours or sooner if needed. The thigh used for securement will be alterned at every change. Receives: Device: GRIP-LOK FOLEY SECUREMENT DEVICE ® |
| Urinary catheter securement with elastic device | Experimental | * Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be selected with the patient's leg bent, to ensure that the securement allows for subsequent leg movement without causing pulling or tension on the catheter.
* Catheter anchoring method: In female patients, the catheter will be anchored at the "Y" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.
* Skin protection: The elastic band will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.
* Application: The device will be applied following the manufacturer's instructions.
* Replacement:The device will be changed every 72 hours, or sooner if necessary. The thigh used for securement will be alternated at every change Receives: Device: CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Catheter-related Meatal pressure injuries incidence
Urinary Catheter-related Meatal pressure injuries are localized damage to the skin and underlying tissues around the urinary meatus resulting from continuous mechanical pressure from the catheter. This pressure can impair blood flow, leading to tissue ischemia, breakdown, and ulceration at the site where the catheter contacts the meatus.
Measured: Through study completion, an average of 10 days
Urinary catheter-related pain in comunicative patients incidence
Urinary catheter-related pain refers to the discomfort or pain experienced by patients as a direct consequence of the presence and use of an indwelling urinary catheter. This pain can arise from mechanical irritation of the urethral mucosa, bladder spasms, inflammation of the urinary tract, and tissue trauma during catheter insertion or prolonged use.
This outcome will be measured only in patients with the ability to communicate effectively. To asses pain severity the Numeric Rating Scale (NRS) will be used. It consists of a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain. Patients will be asked to rate their current pain by choosing a number that best represents their pain level.
Measured: Through study completion, an average of 10 days
Catheter associated-urinary tract infection incidence
Catheter-Associated Urinary Tract Infection (CAUTI) is a type of urinary tract infection that occurs in patients who have an indwelling urinary catheter. It is caused by the introduction and colonization of microorganisms, often bacteria, along the catheter into the urinary tract.
Measured: Through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start22 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de la Santa creu i Sant Pau - Barcelona
- Responsible party
- Sponsor
- Investigators
- Neus Calpe Damians, PhD, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093437
- Sponsor's protocol ID
- IIBSP-DAE-2025-22
- Other IDs
- SLT035/24/000015
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not planned due to limitations in consent obtained from participants. Moreover, the dataset is proprietary and sharing is restricted by institutional policies.
Publications
Shenhar C, Mansvetov M, Baniel J, Golan S, Aharony S. Catheter-associated meatal pressure injury in hospitalized males. Neurourol Urodyn. 2020 Jun;39(5):1456-1463. doi: 10.1002/nau.24372. Epub 2020 Apr 27.
PubMed 32339318Jang EB, Hong SH, Kim KS, Park SY, Kim YT, Yoon YE, Moon HS. Catheter-Related Bladder Discomfort: How Can We Manage It? Int Neurourol J. 2020 Dec;24(4):324-331. doi: 10.5213/inj.2040108.054. Epub 2020 Dec 31.
PubMed 33401353Wound Ostomy and Continence Care Nurses society. Indwelling Urinary Catheter Securement: Best Practice for Clinicians. WOCNS, USA;2012.
Calpe-Damians N, Wennberg-Capellades L, Ventura-Rosado A, Gonzalez-Engroba R, Enriquez-Perez N, Vicario-Martos C, Roldos-Gales A, Guri-Lopez T, Rafart-Aguado S, Ramirez-Ramon A, Llaurado-Serra M. Effectiveness and safety of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients: A randomized controlled trial. Nurs Crit Care. 2024 Nov;29(6):1788-1798. doi: 10.1111/nicc.13111. Epub 2024 Jul 2.
PubMed 38955490Holroyd S. The importance of indwelling urinary catheter securement. Br J Nurs. 2019 Aug 8;28(15):976-977. doi: 10.12968/bjon.2019.28.15.976. No abstract available.
PubMed 31393768Calpe-Damians N, Llaurado-Serra M, Wennberg-Capellades L. Knowledge and beliefs of intensive care nurses about urinary catheter securement: Results of a national survey. Intensive Crit Care Nurs. 2024 Apr;81:103572. doi: 10.1016/j.iccn.2023.103572. Epub 2023 Nov 16.
PubMed 37977003
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental
- ClinicalTrials.gov ID
- NCT07093437
- Acronym / sponsor ID
- IIBSP-DAE-2025-22
- Conditions
- Pressure Injuries, Pain, Catheter-Associated Urinary Tract Infection, Medical Device Site Injury
- Keywords
- Urinary catheter securement, Urinary catheter fixation, Catheter-associated urinary tract infections, pain, Meatal pressure injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Hospital de la Santa creu i Sant Pau - Barcelona
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections .
The main questions the trial aims to answer are:
- Which device type better prevents injuries to the urethral meatus?
- Which device reduces discomfort for patients?
- Which device lowers the incidence of catheter-associated urinary tract infections?
Participants will:
- Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care
- Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter
- Provide feedback on their comfort and any complications experienced, if they are able to communicate
Detailed description
Urinary catheters (UC) are commonly used medical devices in Intensive Care Units (ICU), Between 50 % and 80 % of ICU patients have a UC in place. Although this is a relatively simple device, it is not free from risks, and complications associated with its use can be diverse and potentially serious.
Among the most relevant complications are three. First, catheter-associated urethral meatus injuries, which are lesions caused by continuous pressure from the catheter on surrounding tissues, affecting the glans, penis, or labia minora. The prevalence of these injuries in critically ill patients ranges between 13 % and 36 %. Secondly, pain and discomfort, occurring in approximately 47 % of UC users. Thirdly, catheter-associated urinary tract infection (CAUTI) is a frequent complication; in Spanish ICUs, it has accounted for 25 % to 30 % of all device-associated infections in recent years.
Securing urinay catheter to the leg is recommended by several international clinical practice guidelines (CPG) to prevent complications associated with UC use. In Spain, the national ITU ZERO initiative-led by the Ministry of Health and the Spanish Society of Intensive and Coronary Care Nursing-includes catheter securement as part of recommended care to reduce the risk of UC-related UTIs in critically ill patients.
Recent studies have evaluated the effectiveness of thigh securement of UC in ICU patients. One 2024 study showed that secured catheters significantly reduced the incidence of meatal injuries, decreased associated discomfort and lowered the risk of CAUTI.
Nowadays, two main types of commercial catheter securement devices are available: elastic wristband-style devices and adhesive-based devices. However, recent studies have not directly compared the effectiveness of these two types, and expert opinions vary.
Moreover, CPG recommend securement devices but do not specify which method is best for critically ill patients. This lack of clear guidelines and robust scientific evidence has resulted in low adherence to catheter securement practices among nurses. Prevalence studies from Canada and the UK (2016) reported low adherence rates. A recent qualitative study concluded that this low adherence stemmed from lack of training, ambiguous recommendations, limited scientific evidence, and insufficient engagement of nursing staff in care research.
In conclusion, urinary catheter securement in critically ill patients is a fundamental intervention for preventing complications, yet there remains a clear lack of comparative evidence between available devices, limiting professionals' ability to select the safest and most effective option. This knowledge gap justifies the need for research to determine which of the two securement types-adhesive or elastic-is more beneficial in this patient population.
________________________________________ Hypothesis: In critically ill patients, urinary catheter securement using adhesive devices is more effective than elastic wristband-style devices in preventing urethral meatus injuries, reducing discomfort, and decreasing the incidence of catheter-associated urinary tract infections.
It is proposed that adhesive devices provide greater stability and exert less pressure on tissues, thereby reducing iatrogenic complication risk and improving patient well-being, compared with elastic devices that may cause vascular compromise or skin irritation in edematous or fragile-skin patients.
This hypothesis will be tested by comparing both securement methods in terms of incidence of injuries, pain, and urinary tract infections in critically ill patients requiring long-term urinary catheters.
________________________________________ OBJECTIVES
Primary Objective:
To evaluate and compare the effectiveness of adhesive versus elastic wristband securement devices for urinary catheters in preventing catheter-associated complications in critically ill patients.
Secondary Objectives:
- Compare the effectiveness of adhesive versus elastic securement in preventing urethral meatus injuries in critically ill patients.
- Evaluate the effect of adhesive versus elastic securement on reducing discomfort and pain related to catheter use in critically ill patients able to communicate.
- Compare the incidence of catheter-associated urinary tract infections between groups using adhesive versus elastic securement devices.
- Analyze patient perceptions and experiences (in communicative patients) regarding the two types of securement devices.
- Identify and describe adverse events related to securement device use, such as catheter obstruction, skin lesions, and accidental catheter dislodgment.
METHODOLOGY This study will be conducted in the Intensive Care Unit (ICU) of Hospital de la Santa Creu i Sant Pau. It is an experimental, randomized, open-label trial with two intervention groups. Group 1 (G1) patients will receive urinary catheter securement using a commercially available adhesive device, while Group 2 (G2) patients will use an elastic wristband device. In this study, patients will be randomly assigned to G1 or to G2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary catheter securement with adhesive device | Experimental | Device: GRIP-LOK FOLEY SECUREMENT DEVICE ®* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be chosen with the patient's leg bent, to ensure that the securement allows for future leg movement without causing tension or pulling on the catheter. * Catheter anchoring method: In female patients, the catheter will be anchored at the "Y" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system. * Skin protection: Before applying the adhesive, a protective barrier spray (Cavilon® spray, 3M) will be applied to the selected skin area to prevent potential skin injury * Application: The device will be applied following the manufacturer's instructions. * Replacement: The device will be changed every 72 hours or sooner if needed. The thigh used for securement will be alterned at every change. |
| Urinary catheter securement with elastic device | Experimental | Device: CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be selected with the patient's leg bent, to ensure that the securement allows for subsequent leg movement without causing pulling or tension on the catheter. * Catheter anchoring method: In female patients, the catheter will be anchored at the "Y" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system. * Skin protection: The elastic band will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb. * Application: The device will be applied following the manufacturer's instructions. * Replacement:The device will be changed every 72 hours, or sooner if necessary. The thigh used for securement will be alternated at every change |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Pacients with an urinary catheter inserted within the past 24 hours
- Expected duration of catheterization >48 hours
- Estimated ICU lenght os stay > 48 hours
Key exclusion criteria (4 listed)
- Known allergy to adhesive tape
- Patients with lesions at the urinary meatus, ongoing urinary tract infection or suspected infection
- Presence of urological or prostatic pathology
- Any condition that prevents securing the urinary catheter to the thigh, such as wounds, burns, or amputations
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 |
|---|---|---|
| GRIP-LOK FOLEY SECUREMENT DEVICE ®* Used device: adhesive * Specific Skin protection: with non alcohol barrier film | Device | Urinary catheter securement with adhesive device |
| CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETERThe elastic wristband will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb. | Device | Urinary catheter securement with elastic device |
Primary outcome
Urinary Catheter-related Meatal pressure injuries incidence
Time frame: Through study completion, an average of 10 days
Urinary Catheter-related Meatal pressure injuries are localized damage to the skin and underlying tissues around the urinary meatus resulting from continuous mechanical pressure from the catheter. This pressure can impair blood flow, leading to tissue ischemia, breakdown, and ulceration at the site where the catheter contacts the meatus.
Urinary catheter-related pain in comunicative patients incidence
Time frame: Through study completion, an average of 10 days
Urinary catheter-related pain refers to the discomfort or pain experienced by patients as a direct consequence of the presence and use of an indwelling urinary catheter. This pain can arise from mechanical irritation of the urethral mucosa, bladder spasms, inflammation of the urinary tract, and tissue trauma during catheter insertion or prolonged use. This outcome will be measured only in patients with the ability to communicate effectively. To asses pain severity the Numeric Rating Scale (NRS) will be used. It consists of a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain. Patients will be asked to rate their current pain by choosing a number that best represents their pain level.
Catheter associated-urinary tract infection incidence
Time frame: Through study completion, an average of 10 days
Catheter-Associated Urinary Tract Infection (CAUTI) is a type of urinary tract infection that occurs in patients who have an indwelling urinary catheter. It is caused by the introduction and colonization of microorganisms, often bacteria, along the catheter into the urinary tract.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 32339318Shenhar C, Mansvetov M, Baniel J, Golan S, Aharony S. Catheter-associated meatal pressure injury in hospitalized males. Neurourol Urodyn. 2020 Jun;39(5):1456-1463. doi: 10.1002/nau.24372. Epub 2020 Apr 27.
- Background: PubMed 33401353Jang EB, Hong SH, Kim KS, Park SY, Kim YT, Yoon YE, Moon HS. Catheter-Related Bladder Discomfort: How Can We Manage It? Int Neurourol J. 2020 Dec;24(4):324-331. doi: 10.5213/inj.2040108.054. Epub 2020 Dec 31.
- BackgroundWound Ostomy and Continence Care Nurses society. Indwelling Urinary Catheter Securement: Best Practice for Clinicians. WOCNS, USA;2012.
- Background: PubMed 38955490Calpe-Damians N, Wennberg-Capellades L, Ventura-Rosado A, Gonzalez-Engroba R, Enriquez-Perez N, Vicario-Martos C, Roldos-Gales A, Guri-Lopez T, Rafart-Aguado S, Ramirez-Ramon A, Llaurado-Serra M. Effectiveness and safety of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients: A randomized controlled trial. Nurs Crit Care. 2024 Nov;29(6):1788-1798. doi: 10.1111/nicc.13111. Epub 2024 Jul 2.
- Background: PubMed 31393768Holroyd S. The importance of indwelling urinary catheter securement. Br J Nurs. 2019 Aug 8;28(15):976-977. doi: 10.12968/bjon.2019.28.15.976. No abstract available.
- Background: PubMed 37977003Calpe-Damians N, Llaurado-Serra M, Wennberg-Capellades L. Knowledge and beliefs of intensive care nurses about urinary catheter securement: Results of a national survey. Intensive Crit Care Nurs. 2024 Apr;81:103572. doi: 10.1016/j.iccn.2023.103572. Epub 2023 Nov 16.
- Individual participant dataSharing planned: No. Data sharing is not planned due to limitations in consent obtained from participants. Moreover, the dataset is proprietary and sharing is restricted by institutional policies.
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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.
Neus Calpe Damians, PhD study director
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRIP-LOK FOLEY SECUREMENT DEVICE ® and CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER in people with Pressure Injuries and Pain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neus Calpe Damians, PhD (+34 932 91 90 00, ncalpe@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Catheter-related Meatal pressure injuries incidence (time frame: Through study completion, an average of 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093437, which also lists 6 linked publications.
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 10 Dec 2025.