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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06967116
Enrollment
248
Registered
2025-05-13
Start date
2024-10-18
Completion date
2025-04-30
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injury, Urinary Catheter-Related Discomfort

Keywords

meatal pressure injury, fixation, intensive care, urinary catheter

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.

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.

Interventions

PROCEDUREProcedure Steps

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

Sponsors

Merve Zorlu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Meatal Pressure Injury Staging SystemInitial 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.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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026