RecruitingNot ApplicableNCT07287488

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)


Sponsor

Saglik Bilimleri Universitesi

Enrollment

60 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria3

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

Exclusion Criteria1

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

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Interventions

DEVICEInnovative 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.

PROCEDURERoutine 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.


Locations(1)

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)

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NCT07287488