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

NCT ID: NCT07287488

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2026-02-21

Brief Summary

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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.

Detailed Description

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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:

* Restricted patient mobility, which may increase the risk of deep vein thrombosis (DVT)
* Inconsistent pressure on the prostatic capsule due to patient movement
* Risk of infection if materials become wet
* Irritation and discomfort due to friction on the glans penis
* Difficulty maintaining consistent and sustainable traction In clinical practice, an alternative method often used involves securing the catheter with gauze around the penis after applying traction. While this method allows patient mobility, it still carries risks related to hygiene, durability, and discomfort.

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:

1. To assess the usability and practicality of the new catheter traction device in a simulated environment
2. To evaluate healthcare professionals' perspectives regarding the safety, effectiveness, and ease of application of the device This study provides essential preliminary data for the design of future clinical trials involving human participants, aiming to improve postoperative hemorrhage management following TURP.

Conditions

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Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP

Keywords

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TURP (Transurethral Resection of Prostate) Urethral Catheter Traction Bleeding Control in TURP Catheter Traction Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized Crossover Controlled Trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The intervention was tested on mannequins; users and investigators were aware of the intervention, but outcome assessment was blinded

Study Groups

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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.

Group Type EXPERIMENTAL

Innovative Urethral Catheter Traction Device

Intervention Type 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.

Control Arm

Participants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form".

Group Type ACTIVE_COMPARATOR

Routine Urethral Catheter Traction

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Individuals who do not wish to participate or withdraw consent during the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Özlem Yılmaz

PhD Student / Doctoral Candidate (Clinical Nurse Specialist background)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik Şehir Hastanesi

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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özlem yılmaz, PhD (Candidate)

Role: CONTACT

Phone: +90 05388906926

Email: [email protected]

Facility Contacts

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T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi

Role: primary

Other Identifiers

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AEŞH-EK-2025-218

Identifier Type: -

Identifier Source: org_study_id