Clinical trial NCT06967116: Impact of Urinary Catheter Fixation on Meatal Pressure Injury in Male Patients in the Intensive Care Unit
Official title: The Effect of Urinary Catheter Fixation on the Development of Meatal Pressure Injury in Male Patients Treated in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Catheter-Related Discomfort
Pressure Injury
Keywords: meatal pressure injury
fixation
intensive care
urinary catheter
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 248
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Meatal Pressure Injury Staging System
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul University
Study officials:
affiliation: Istanbul University Nursinf Faculty
name: Yasemin Uslu, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.