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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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