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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-18

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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

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Urinary Catheter-Related Discomfort Pressure Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group (Using urinary catheter fixation tape)

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.

Group Type EXPERIMENTAL

Procedure Steps

Intervention Type PROCEDURE

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

Control Group (standard care)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Procedure Steps

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No