Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study

NCT07093437 | Recruiting DMC

• 2 other identifiers: IIBSP-DAE-2025-22SLT035/24/000015
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Pain; Pressure Injuries; 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 10 days

Study Arms (2)

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.

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

Device: CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER

Interventions

GRIP-LOK FOLEY SECUREMENT DEVICE ® DEVICE

* Used device: adhesive * Specific Skin protection: with non alcohol barrier film

Urinary catheter securement with adhesive device

CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER DEVICE

The elastic wristband will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.

Urinary catheter securement with elastic device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Hospital de la Santa creu i Sant Pau - Barcelona: collaborator

Study Sites (1)

Institut de Recerca Sant Pau

Barcelona, 08024, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 32339318 BACKGROUND

• Jang 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.

  PMID: 33401353 BACKGROUND

• Wound Ostomy and Continence Care Nurses society. Indwelling Urinary Catheter Securement: Best Practice for Clinicians. WOCNS, USA;2012.

  BACKGROUND

• 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.

  PMID: 38955490 BACKGROUND

• Holroyd 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.

  PMID: 31393768 BACKGROUND

• Calpe-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.

  PMID: 37977003 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Pain

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Neus Calpe Damians, PhD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY DIRECTOR

Central Study Contacts

Neus Calpe Damians, PhD

CONTACT

+34 932 91 90 00; ncalpe@santpau.cat

Mireia Llauradó Serra, PhD

CONTACT

+34665033050; mireia.llaurado@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 30, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)