Development and Pilot Evaluation of a Urethral Catheter Traction Device for Post-TURP Hemorrhage Control

Development and Evaluation of an Innovative Urethral Catheter Traction Device for Hemorrhage Control Following Transurethral Resection of the Prostate (TURP)

Benign prostatic hyperplasia (BPH) is a common condition among elderly men. Transurethral resection of the prostate (TURP) is the gold standard surgical procedure, but postoperative bleeding is a frequent complication. Traditional catheter traction methods to control bleeding-such as fixing the catheter to the thigh or abdomen or using weights-have limitations, including restricted patient mobility, inconsistent pressure, and risk of infection or irritation.

This study aims to develop an innovative urethral catheter traction device that provides effective and stable pressure, is easy to apply, and minimizes potential complications. The device was tested in a simulated environment on mannequins. Both users and investigators were aware of the intervention, while outcome assessment was blinded. The study also evaluates healthcare professionals' perspectives on the usability, safety, and practicality of the device.

Study Overview

• Status: Recruiting
• Conditions: Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP
• Intervention / Treatment: Device: Innovative Urethral Catheter Traction Device; Procedure: Routine Urethral Catheter Traction

Detailed Description

Benign prostatic hyperplasia (BPH) is a common health issue among elderly men, and transurethral resection of the prostate (TURP) is the gold standard surgical intervention. Postoperative bleeding is one of the most frequent complications of TURP, and controlling hemorrhage is essential for patient safety. Traditional methods for applying traction to the urethral catheter, including fixing the catheter to the thigh or abdomen or attaching weights to the catheter tip, have demonstrated efficacy in bleeding control. However, these approaches have several significant drawbacks:

• Restricted patient mobility, which may increase the risk of deep vein thrombosis (DVT)
• Inconsistent pressure on the prostatic capsule due to patient movement
• Risk of infection if materials become wet
• Irritation and discomfort due to friction on the glans penis
• Difficulty maintaining consistent and sustainable traction In clinical practice, an alternative method often used involves securing the catheter with gauze around the penis after applying traction. While this method allows patient mobility, it still carries risks related to hygiene, durability, and discomfort.

Given these limitations, there is a need for a device that can provide effective, stable, and safe traction, while being easy to apply and comfortable for the patient.

This study focuses on the development and evaluation of an innovative urethral catheter traction device. The device was tested in a simulated environment using mannequins. The intervention was fully visible to both the users and investigators, ensuring proper handling and application, while outcome assessment was conducted in a blinded manner to reduce bias.

The primary objectives of this study are:

1. To assess the usability and practicality of the new catheter traction device in a simulated environment
2. To evaluate healthcare professionals' perspectives regarding the safety, effectiveness, and ease of application of the device This study provides essential preliminary data for the design of future clinical trials involving human participants, aiming to improve postoperative hemorrhage management following TURP.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: özlem yılmaz, PhD (Candidate); Phone Number: +90 05388906926; Email: ozlem.yilmaz76@saglik.gov.tr

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06170
      • Recruiting
      • Ankara Etlik Şehir Hastanesi
      • Contact: T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi; Phone Number: +90 0312 797 00 00; Email: etliksh.iletisim@saglik.gov.tr
      • Principal Investigator: özlem yılmaz, PhD (Candidate)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Active operating room nurse or urology specialist physician.
• Experienced in urethral catheter application.
• Signed informed consent form voluntarily.

Exclusion Criteria:

• Individuals who do not wish to participate or withdraw consent during the study.
• Individuals who do not meet the inclusion criteria.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Participants apply the innovative urethral catheter traction device on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form" and the Quebec Assistive Technology User Satisfaction Survey.	Device: Innovative Urethral Catheter Traction Device; A prototype urethral catheter traction device applied on mannequins to assess usability, safety, and effectiveness. Participants (operating room nurses and urology physicians) apply the device following a standardized protocol. Outcome assessment is performed by blinded assessors. Post-procedure, participants complete evaluation forms and user satisfaction surveys.
Active Comparator: Control Arm; Participants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form".	Procedure: Routine Urethral Catheter Traction; Standard catheter traction method performed on mannequins, representing usual clinical practice. Participants apply traction according to routine procedures. Outcome assessment is performed by blinded assessors. Post-procedure, participants complete evaluation forms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Application Between the Innovative and Routine Urethral Catheter Traction Methods	This outcome assesses the ease of application of the newly developed urethral catheter traction device compared to the traditional traction method during simulated practice on mannequins. Participants will rate ease of use based on a standardized "Urethral Catheter Traction Procedure Evaluation Form." Related Hypothesis (H₁₀): There is no significant difference in ease of application between the innovative device and the traditional method.	Immediately after each intervention session (within 1 hour).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability and Safety of Catheter Traction Between the Innovative and Routine Methods	This outcome evaluates the stability and safety of catheter traction provided by the innovative device compared with the routine method. Participants and assessors will evaluate tractive stability and potential complications (e.g., displacement, pressure inconsistency) using structured observation checklists. Related Hypothesis (H₂₀): There is no significant difference in stability and safety of traction between the innovative device and the traditional method.	Immediately after both intervention and control sessions.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2025
• Primary Completion (Estimated): January 21, 2026
• Study Completion (Estimated): February 21, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: TURP (Transurethral Resection of Prostate); Urethral Catheter Traction; Bleeding Control in TURP; Catheter Traction Techniques
• Other Study ID Numbers: AEŞH-EK-2025-218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, individual participant data will not be shared. Data are limited and anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No