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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Ease of Application Between the Innovative and Routine Urethral Catheter Traction Methods [Time frame: Immediately after each intervention session (within 1 hour).]

Secondary outcome measures (1)

• Stability and Safety of Catheter Traction Between the Innovative and Routine Methods [Time frame: Immediately after both intervention and control sessions.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Health services research

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik Şehir Hastanesi — Ankara

Identifiers

NCT: NCT07287488 · AEŞH-EK-2025-218

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗