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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• Active operating room nurse or urology specialist physician.

• Experienced in urethral catheter application.

• Signed informed consent form voluntarily.

Locations
Other Locations
Turkey
Ankara Etlik Şehir Hastanesi
RECRUITING
Ankara
Contact Information
Primary
özlem yılmaz, PhD (Candidate)
ozlem.yilmaz76@saglik.gov.tr
+90 05388906926
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2026-02-21
Participants
Target number of participants: 60
Treatments
Experimental: Intervention Arm
Participants apply the innovative urethral catheter traction device on mannequins. Post-procedure, users complete the Catheter Traction Procedure Evaluation Form and the Quebec Assistive Technology User Satisfaction Survey.
Active_comparator: Control Arm
Participants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the Catheter Traction Procedure Evaluation Form.
Related Therapeutic Areas
Sponsors
Leads: Saglik Bilimleri Universitesi

This content was sourced from clinicaltrials.gov