Urinary CatheterizationNCT07327671
Positioning Device for Female Urinary Catheterization
A study testing dorsal recumbent positioning device in people with Urinary Catheterization and Device, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Urinary Catheterization, Device, Nursing
- What is being tested?
- dorsal recumbent positioning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2023to 21 Feb 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a nurse with at least a bachelor's degree
- Previous experience of urinary catheterization
- Having worked or working in intensive care
- Having voluntarily agreed to participate in the research
Who cannot join
- Leaving work voluntarily
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara, Turkey
Ankara
About this study
Official title: Developing and Efficiency Evaluation of a Positioning Assist Device for Urinary Catheterization in Female Patients
In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Especially in unconscious or uncooperative female patients, it is much more difficult to maintain and maintain an appropriate position, and more than one staff may be needed for this. Although it is clear that it is important and difficult to position female patients during catheterization and maintain it throughout the procedure, no device used to assist positioning has been encountered. Therefore, in this project; The aim of this study is to provide a comfortable and safe position for the patient in urinary catheterization in female patients, to develop an auxiliary device to maintain this position throughout the procedure, and to evaluate the effectiveness of this device.
Read the detailed description
Urinary elimination is one of the most fundamental physiological needs, and when it cannot be met by the individual for any reason, urinary catheterisation is required to drain urine accumulated in the bladder. Urinary catheterisation consists of a series of sequential steps. The first step is positioning the patient. In female patients, the dorsal recumbent position is required to visualise the urethral meatus. Once an appropriate position has been achieved in female patients, direct visualisation of the urethral meatus is crucial for the successful advancement of the catheter under sterile conditions. Providing and maintaining an appropriate position is particularly difficult in unconscious or uncooperative female patients, and may require multiple personnel. Although it is clear that positioning female patients during catheterisation and maintaining this position throughout the procedure is important and difficult, no devices have been found to assist with positioning. Therefore, this project aims to develop an assistive device to provide female patients with a comfortable and safe position during urinary catheterisation and to maintain this position throughout the procedure, and to evaluate the effectiveness of this device. To this end, a new positioning cushion will be developed, and a preclinical validation study will be conducted using a mixed-methods research design that includes a randomised controlled trial and a descriptive qualitative study.
- Conditions
- Urinary Catheterization, Device, Nursing, Positioning (Prone, Right Lateral and Semi-Elevated Supine Position), Randomised Controlled Trial
- Being tested
- dorsal recumbent positioning device
- Keywords
- urinary catheterization, assistive device, nursing, usebility testing, randomized cross-over trial, positioning device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorsal recumbent positioning deviceDevice
Participants in the supine positioning device group use this device prior to the procedure to ensure the supine position during urinary catheterisation in female patients. Once this device has safely secured the position, the steps for urinary catheterisation are carried out.
| Study group | Role | What they receive |
|---|---|---|
| dorsal recumbent positioning device | Experimental | procedure performed with dorsal recumbent positioning device Receives: Device: dorsal recumbent positioning device |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Catheterization Procedure Time (minutes)
Total time required to complete the urinary catheterization procedure, measured in minutes from video recordings, including preparation time, catheter insertion time, and total procedure duration.
Measured: From the start to the end of the catheterisation procedure, a maximum of 10 minutes
Nurses' Lumbar Fatigue (Visual Analog Scale, VAS 0-100)
Lower back fatigue experienced by nurses during the procedure, assessed using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater fatigue.
Measured: Day 1
Need for Support Personnel
Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.
Measured: Day 1
Nurses' Physical Effort (Visual Analog Scale, VAS 0-100)
Physical effort perceived by nurses during the catheterization procedure, measured using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater physical effort.
Measured: Day 1
Secondary outcomes (1)
User Satisfaction (QUEST 2.0)
Satisfaction with the dorsal recumbent positioning device measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start27 Feb 2023
- Primary completion29 Sep 2023
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary CatheterizationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Bircan Kolcak, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327671
- Sponsor's protocol ID
- 23232323
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fletcher-Gutowski S, Cecil J. Is 2-person urinary catheter insertion effective in reducing CAUTI? Am J Infect Control. 2019 Dec;47(12):1508-1509. doi: 10.1016/j.ajic.2019.05.014. Epub 2019 Jul 16.
PubMed 31324489Santos-Costa P, Alves M, Sousa C, Sousa LB, Paiva-Santos F, Bernardes RA, Ventura F, Salgueiro-Oliveira A, Parreira P, Vieira M, Graveto J. Nurses' Involvement in the Development and Usability Assessment of an Innovative Peripheral Intravenous Catheterisation Pack: A Mix-Method Study. Int J Environ Res Public Health. 2022 Sep 5;19(17):11130. doi: 10.3390/ijerph191711130.
PubMed 36078842
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Efficiency Evaluation of a Positioning Assist Device for Urinary Catheterization in Female Patients
- ClinicalTrials.gov ID
- NCT07327671
- Acronym / sponsor ID
- 23232323
- Conditions
- Urinary Catheterization, Device, Nursing, Positioning (Prone, Right Lateral and Semi-Elevated Supine Position), Randomised Controlled Trial
- Keywords
- urinary catheterization, assistive device, nursing, usebility testing, randomized cross-over trial, positioning device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 8 Jan 2026 (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.
In female patients, the dorsal recumbent position is required to visualize the urethral meatus. In female patients, direct visualization of the urethral meatus after providing a suitable position is very important for successful catheter advancement while maintaining sterile conditions. Especially in unconscious or uncooperative female patients, it is much more difficult to maintain and maintain an appropriate position, and more than one staff may be needed for this. Although it is clear that it is important and difficult to position female patients during catheterization and maintain it throughout the procedure, no device used to assist positioning has been encountered. Therefore, in this project; The aim of this study is to provide a comfortable and safe position for the patient in urinary catheterization in female patients, to develop an auxiliary device to maintain this position throughout the procedure, and to evaluate the effectiveness of this device.
Detailed description
Urinary elimination is one of the most fundamental physiological needs, and when it cannot be met by the individual for any reason, urinary catheterisation is required to drain urine accumulated in the bladder. Urinary catheterisation consists of a series of sequential steps. The first step is positioning the patient. In female patients, the dorsal recumbent position is required to visualise the urethral meatus. Once an appropriate position has been achieved in female patients, direct visualisation of the urethral meatus is crucial for the successful advancement of the catheter under sterile conditions. Providing and maintaining an appropriate position is particularly difficult in unconscious or uncooperative female patients, and may require multiple personnel. Although it is clear that positioning female patients during catheterisation and maintaining this position throughout the procedure is important and difficult, no devices have been found to assist with positioning. Therefore, this project aims to develop an assistive device to provide female patients with a comfortable and safe position during urinary catheterisation and to maintain this position throughout the procedure, and to evaluate the effectiveness of this device. To this end, a new positioning cushion will be developed, and a preclinical validation study will be conducted using a mixed-methods research design that includes a randomised controlled trial and a descriptive qualitative study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dorsal recumbent positioning device | Experimental | Device: dorsal recumbent positioning deviceprocedure performed with dorsal recumbent positioning device |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a nurse with at least a bachelor's degree
- Previous experience of urinary catheterization
- Having worked or working in intensive care
- Having voluntarily agreed to participate in the research
Key exclusion criteria (1 listed)
- Leaving work voluntarily
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 |
|---|---|---|
| dorsal recumbent positioning deviceParticipants in the supine positioning device group use this device prior to the procedure to ensure the supine position during urinary catheterisation in female patients. Once this device has safely secured the position, the steps for urinary catheterisation are carried out. | Device | dorsal recumbent positioning device |
Primary outcome
Urinary Catheterization Procedure Time (minutes)
Time frame: From the start to the end of the catheterisation procedure, a maximum of 10 minutes
Total time required to complete the urinary catheterization procedure, measured in minutes from video recordings, including preparation time, catheter insertion time, and total procedure duration.
Nurses' Lumbar Fatigue (Visual Analog Scale, VAS 0-100)
Time frame: Day 1
Lower back fatigue experienced by nurses during the procedure, assessed using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater fatigue.
Need for Support Personnel
Time frame: Day 1
Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.
Nurses' Physical Effort (Visual Analog Scale, VAS 0-100)
Time frame: Day 1
Physical effort perceived by nurses during the catheterization procedure, measured using a Visual Analogue Scale (VAS) from 0 to 100, where higher scores indicate greater physical effort.
1 secondary outcome
User Satisfaction (QUEST 2.0)
Time frame: Day 1
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 8 Jan 2026.
- Background: PubMed 31324489Fletcher-Gutowski S, Cecil J. Is 2-person urinary catheter insertion effective in reducing CAUTI? Am J Infect Control. 2019 Dec;47(12):1508-1509. doi: 10.1016/j.ajic.2019.05.014. Epub 2019 Jul 16.
- Background: PubMed 36078842Santos-Costa P, Alves M, Sousa C, Sousa LB, Paiva-Santos F, Bernardes RA, Ventura F, Salgueiro-Oliveira A, Parreira P, Vieira M, Graveto J. Nurses' Involvement in the Development and Usability Assessment of an Innovative Peripheral Intravenous Catheterisation Pack: A Mix-Method Study. Int J Environ Res Public Health. 2022 Sep 5;19(17):11130. doi: 10.3390/ijerph191711130.
- Urinary Catheter Care Guidelines Version: 6Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dorsal recumbent positioning device in people with Urinary Catheterization and Device, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 1 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 8 Jan 2026. 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?
Urinary Catheterization Procedure Time (minutes) (time frame: From the start to the end of the catheterisation procedure, a maximum of 10 minutes). The study lists 4 primary outcomes in all. 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 NCT07327671, which also lists 2 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 8 Jan 2026.