Urinary Catheter-Related DiscomfortNCT06967116
Impact of Urinary Catheter Fixation on Meatal Pressure Injury in Male Patients in the Intensive Care Unit
A study testing Procedure Steps in people with Urinary Catheter-Related Discomfort and Pressure Injury, run by Merve Zorlu at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Catheter-Related Discomfort, Pressure Injury
- What is being tested?
- Procedure Steps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Urinary Catheter Fixation on the Development of Meatal Pressure Injury in Male Patients Treated in Intensive Care Unit
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.
Read the 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.
- Being tested
- Procedure Steps
- Keywords
- meatal pressure injury, fixation, intensive care, urinary catheter
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure StepsProcedure or surgery
The data of the study were collected with the 'Patient Identification Form' and 'Meatal Pressure Injury Daily Monitoring Form'.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start18 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary Catheter-Related DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Zorlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Zorlu, Istanbul University
- Investigators
- Yasemin Uslu, Assoc. Prof., Study director, Istanbul University Nursinf Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967116
- Sponsor's protocol ID
- IU2024- 2948112
- Status last verified
- Jul 2024
- First submitted
- 1 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The hypothesis results of the research will be shared. In this regard; * prevalence of meatal pressure injury * risk factors that increase meatal pressure injury
Publications
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.
PubMed 38404556Rassin 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.
PubMed 23388870Appah 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.
PubMed 26418849Shenhar 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.
PubMed 32339318de 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.
PubMed 37264262Calpe-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.
PubMed 38955490
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Urinary Catheter Fixation on the Development of Meatal Pressure Injury in Male Patients Treated in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06967116
- Acronym / sponsor ID
- IU2024- 2948112
- Keywords
- meatal pressure injury, fixation, intensive care, urinary catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Merve ZorluUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Using urinary catheter fixation tape) | Experimental | Procedure: Procedure StepsThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure StepsThe data of the study were collected with the 'Patient Identification Form' and 'Meatal Pressure Injury Daily Monitoring Form'. | Procedure or surgery | Experimental group (Using urinary catheter fixation tape) |
Primary outcome
Meatal Pressure Injury Staging System
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Results publication: PubMed 38404556Munien 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.
- Results publication: PubMed 23388870Rassin 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.
- Results publication: PubMed 26418849Appah 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.
- Results publication: PubMed 32339318Shenhar 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.
- Results publication: PubMed 37264262de 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.
- Results publication: PubMed 38955490Calpe-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.
- Individual participant dataSharing planned: Yes. The hypothesis results of the research will be shared. In this regard; * prevalence of meatal pressure injury * risk factors that increase meatal pressure injury
Related trials for Urinary Catheter-Related Discomfort
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
RecruitingPhase 4
Effect of Dexmedetomidine and Esketamine on Catheter-related Bladder Discomfort
Urinary Catheter, Catheter-related Bladder Discomfort
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Uslu, Assoc. Prof. study director
Istanbul University Nursinf Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure Steps in people with Urinary Catheter-Related Discomfort and Pressure Injury, run by Merve Zorlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meatal Pressure Injury Staging System (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06967116, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.