NCT06967116

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

The Effect of Urinary Catheter Fixation on the Development of Meatal Pressure Injury in Male Patients Treated in Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Merve Zorlu · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, data were collected by the researcher from the hospital's electronic patient record system and by physical examination. Patients admitted to ICU were divided into two groups as experimental and control. The meatal pressure injury due to urinary catheter was determined by the investigator through physical examination. The first observation was made within the first 24 hours after the patient's admission to the clinic. During the physical examination, the patient's perineum was evaluated in terms of tissue integrity, moisture status, edema, lesions and redness and recorded by ensuring patient privacy. Physical examinations were performed by the researcher twice a day at the same time (08:00-09:00 in the morning and 20:00-21:00 in the evening). The data collection period was considered as 14 days. In case of meatal pressure injury, exitus, transfer of the patient to another unit, or removal of the urinary catheter, the data collection phase was terminated without waiting for the 14-day data collection follow-up period. The study included 248 patients, 124 in the experimental group and 124 in the control group. Patients were randomly assigned to the experimental and control groups according to their sequence numbers. The study was designed as an open-label, randomized and controlled experimental study. A simple computer-assisted randomization method was used to ensure homogeneous group distribution. For this purpose, 248 sets were created using the functions available on the website "https://www.random.org/integer-sets". The Meatal Pressure Injury Staging System developed by Shenhar (2020) categorizes injuries into four grades: Grade 1 Meatal Pressure Injury: Erythematous, intact skin and mucosa. Grade 2 Meatal Pressure Injury: Partial loss of thick skin and mucosa. Grade 3 Meatal Pressure Injury: Less than 2 cm loss of full thickness skin and urethral mucosa. Grade 4 Meatal Pressure Injury: Loss of 2 cm or more of full thickness skin and urethral mucosa. In the study by Shenhar et al. these parameters were evaluated daily for two weeks. Permission to use the form was obtained from the responsible author.

Conditions

• Urinary Catheter-Related Discomfort
• Pressure Injury

Interventions

Type	Name	Description
PROCEDURE	Procedure Steps	The data of the study were collected with the 'Patient Identification Form' and 'Meatal Pressure Injury Daily Monitoring Form'.

Timeline

• Start date: 2024-10-18
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: Turkey (Türkiye)