Positioning Device for Female Urinary Catheterization

December 25, 2025 updated by: Bircan Kolcak, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Leaving work voluntarily

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: dorsal recumbent positioning device
procedure performed with dorsal recumbent positioning device
Device: dorsal recumbent positioning device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start to the end of the catheterisation procedure, a maximum of 10 minutes
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.
Day 1
Need for Support Personnel
Time Frame: Day 1
Requirement for additional support staff during the procedure, recorded as yes/no based on video analysis.
Day 1
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Satisfaction (QUEST 2.0)
Time Frame: Day 1
Satisfaction with the dorsal recumbent positioning device measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Collaborators

The Scientific and Technological Research Council of Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

February 21, 2024

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23232323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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