Impact of Urinary Catheter Fixation on Meatal Pressure Injury in Male Patients in the Intensive Care Unit

NCT06967116 | Completed

• 1 other identifier: IU2024- 2948112
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

Meatal pressure injury refers to the injury and ulceration of the head and shaft of the penis resulting from the constant pressure of an indwelling catheter. It can cause complications ranging from irritation and erythema of the skin and urethral epithelium to full-thickness tissue loss, penile deformity, and complete division of the penis, which may lead to sexual and urinary dysfunction. These complications can result in decreased quality of life and increased morbidity. Meatal pressure injury is a common problem in male patients in the ICU. However, studies on the prevention of meatal pressure injuries are very limited. This study is planned to evaluate the effectiveness of a urinary catheter fixation method on the development of meatal pressure injury in male patients treated in the intensive care unit.

Conditions

Urinary Catheter-Related Discomfort; Pressure Injury

Keywords

meatal pressure injury; fixation; intensive care; urinary catheter

Outcome Measures

Primary Outcomes (1)

• Meatal Pressure Injury Staging System

  Meatal Pressure Injury Staging System patients were monitored at 12 hour intervals. The patient's perineum and glans head were evaluated by observation. The staging system evaluates with 4 grades. These stages are as follows: * Grade 1: Meatus erosion is limited within the glans. Penile cleavage extends from the meatus to the proximal part of the cor-ona glans penis. * Grade 2: Erosion of the distal 1/3 of the penile shaft. Penile cleft extends from the meatus to the subcoronal part of the penis. * Grade 3: Erosion of the middle 1/3 of the penile shaft. Penile cleft extends from the meatus to the scrotum. * Grade 4: Erosion of the proximal 1/3 of the penile shaft/penoscrotal junction. The meatus is unaffected, but pressure necrosis is seen along the penile shaft.

  Initial observation was made right after patient admission. Observations were repeated at 12-hour intervals for up to 14 days. Data collection was stopped earlier if a meatal pressure injury, death, transfer to another unit, or catheter removal occurred.

Study Arms (2)

Experimental group (Using urinary catheter fixation tape)

EXPERIMENTAL

The area around the catheter entry point was cleaned twice a day during daytime (between 10.00-12.00) and evening (between 19.00-22.00) care hours of the unit and in case of additional need. On the first admission of the patient to the ICU, the urinary catheter was fixed to the leg with a fixation product and the catheter placement was changed to the other leg every 24 hours. The fixation product to be used fits every leg size thanks to its flexible structure and is securely fixed to the leg.

Procedure: Procedure Steps

Control Group (standard care)

NO INTERVENTION

The area around the catheter entry point was cleaned during the daytime (10.00-12.00) and evening (19.00-22.00) maintenance hours of the unit and twice daily as needed.

Interventions

Procedure Steps PROCEDURE

The data of the study were collected with the 'Patient Identification Form' and 'Meatal Pressure Injury Daily Monitoring Form'.

Experimental group (Using urinary catheter fixation tape)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since penis- related meatal pressure injury was evaluated in the study, male patients were included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Male patients in intensive care unit for at least 24 hours
• No existing meatal pressure injury
• Patients with urinary catheter on admission to the intensive care unit or urinary catheter inserted after intensive care unit admission

You may not qualify if:

• A skin disease that interferes with the assessment of pressure injury
• Any surgical intervention that prevents the evaluation of the meatal region
• Patients with condom urinary catheter

Sponsors & Collaborators

• Merve Zorlu: lead

Study Sites (1)

İstanbul University

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Munien K, Ravichandran K, Flynn H, Shugg N, Flynn D, Chambers J, Desai D. Catheter-associated meatal pressure injuries (CAMPI) in patients with long-term urethral catheters-a cross-sectional study of 200 patients. Transl Androl Urol. 2024 Jan 31;13(1):42-52. doi: 10.21037/tau-23-445. Epub 2024 Jan 23.

  PMID: 38404556 BACKGROUND

• Rassin M, Markovski I, Fishlov A, Naveh RU. An evaluation of preventing pressure ulcers in the urinary meatus. Dimens Crit Care Nurs. 2013 Mar-Apr;32(2):95-8. doi: 10.1097/DCC.0b013e31826bc65f.

  PMID: 23388870 BACKGROUND

• Appah Y, Hunter KF, Moore KN. Securement of the Indwelling Urinary Catheter: A Prevalence Study. J Wound Ostomy Continence Nurs. 2016 Mar-Apr;43(2):173-7. doi: 10.1097/WON.0000000000000176.

  PMID: 26418849 BACKGROUND

• 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

• de Paula FM, Frota OP, Ruiz JS, Braulio IC, do Nascimento Goncalves FC, Ferreira-Junior MA, Sonobe HM, Ferreira DN, Pompeo CM, de Sousa AFL. Safety and efficacy of silicone tape for indwelling urinary catheter fixation in intensive care patients-A randomized clinical trial. Nurs Crit Care. 2024 Mar;29(2):347-356. doi: 10.1111/nicc.12937. Epub 2023 Jun 1.

  PMID: 37264262 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

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yasemin Uslu, Assoc. Prof.

  Istanbul University Nursinf Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 13, 2025
• Study Start: October 18, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)