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RECRUITING
NCT07287488
NA

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

Sponsor: Saglik Bilimleri Universitesi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-08-21

Completion Date

2026-02-21

Last Updated

2025-12-17

Healthy Volunteers

Yes

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.

Locations (1)

Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)