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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.
Benign prostatic hyperplasia (BPH) is a common health issue among elderly men, and transurethral resection of the prostate (TURP) is the gold standard surgical intervention. Postoperative bleeding is one of the most frequent complications of TURP, and controlling hemorrhage is essential for patient safety. Traditional methods for applying traction to the urethral catheter, including fixing the catheter to the thigh or abdomen or attaching weights to the catheter tip, have demonstrated efficacy in bleeding control. However, these approaches have several significant drawbacks:
Given these limitations, there is a need for a device that can provide effective, stable, and safe traction, while being easy to apply and comfortable for the patient.
This study focuses on the development and evaluation of an innovative urethral catheter traction device. The device was tested in a simulated environment using mannequins. The intervention was fully visible to both the users and investigators, ensuring proper handling and application, while outcome assessment was conducted in a blinded manner to reduce bias.
The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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. |
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| Control Arm | Active Comparator | Participants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovative Urethral Catheter Traction Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Application Between the Innovative and Routine Urethral Catheter Traction Methods | 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. | Immediately after each intervention session (within 1 hour). |
| Measure | Description | Time Frame |
|---|---|---|
| Stability and Safety of Catheter Traction Between the Innovative and Routine Methods | This outcome evaluates the stability and safety of catheter traction provided by the innovative device compared with the routine method. Participants and assessors will evaluate tractive stability and potential complications (e.g., displacement, pressure inconsistency) using structured observation checklists. Related Hypothesis (H₂₀): There is no significant difference in stability and safety of traction between the innovative device and the traditional method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| özlem yılmaz, PhD (Candidate) | Contact | +90 05388906926 | ozlem.yilmaz76@saglik.gov.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik Şehir Hastanesi | Recruiting | Ankara | Yenimahalle | 06170 | Turkey (Türkiye) |
No, individual participant data will not be shared. Data are limited and anonymized.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2026 | |
| Reset | May 11, 2026 |
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Randomized Crossover Controlled Trial
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The intervention was tested on mannequins; users and investigators were aware of the intervention, but outcome assessment was blinded
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| Routine Urethral Catheter Traction | Procedure | 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. |
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| Immediately after both intervention and control sessions. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2026 | May 11, 2026 |