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)
Saglik Bilimleri Universitesi
60 participants
Aug 21, 2025
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
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.
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)
View Full Details on ClinicalTrials.gov
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NCT07287488