Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURPNCT07287488
Development and Pilot Evaluation of a Urethral Catheter Traction Device for Post-TURP Hemorrhage Control
A study testing Innovative Urethral Catheter Traction Device and Routine Urethral Catheter Traction in people with Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP
- What is being tested?
- Innovative Urethral Catheter Traction Device and Routine Urethral Catheter Traction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2025to 21 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Active operating room nurse or urology specialist physician.
- Experienced in urethral catheter application.
- Signed informed consent form voluntarily.
Who cannot join
- Individuals who do not wish to participate or withdraw consent during the study.
- Individuals who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik Şehir Hastanesi
Ankara, Yenimahalle, 06170
T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi T.C. Sağlık Bakanlığı Ankara Etlik Şehir Hastanesi, +90 0312 797 00 00, etliksh.iletisim@saglik.gov.tr
özlem yılmaz, PhD (Candidate)
About this study
Official title: Development and Evaluation of an Innovative Urethral Catheter Traction Device for Hemorrhage Control Following Transurethral Resection of the Prostate (TURP)
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.
Read the detailed description
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:
- To assess the usability and practicality of the new catheter traction device in a simulated environment
- 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
- Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP
- Being tested
- Innovative Urethral Catheter Traction Device, Routine Urethral Catheter Traction
- Keywords
- TURP (Transurethral Resection of Prostate), Urethral Catheter Traction, Bleeding Control in TURP, Catheter Traction Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Urethral Catheter Traction DeviceDevice
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.
Routine Urethral Catheter TractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Innovative Urethral Catheter Traction Device |
| Control Arm | Active comparator | Participants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form". Receives: Procedure: Routine Urethral Catheter Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after each intervention session (within 1 hour).
Secondary outcomes (1)
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.
Measured: Immediately after both intervention and control sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start21 Aug 2025
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURPStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Crossover Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Yılmaz, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287488
- Sponsor's protocol ID
- AEŞH-EK-2025-218
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data will not be shared. Data are limited and anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Innovative Urethral Catheter Traction Device for Hemorrhage Control Following Transurethral Resection of the Prostate (TURP)
- ClinicalTrials.gov ID
- NCT07287488
- Acronym / sponsor ID
- AEŞH-EK-2025-218
- Conditions
- Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP
- Keywords
- TURP (Transurethral Resection of Prostate), Urethral Catheter Traction, Bleeding Control in TURP, Catheter Traction Techniques
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Feb 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- To assess the usability and practicality of the new catheter traction device in a simulated environment
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Crossover Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Innovative Urethral Catheter Traction DeviceParticipants 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. |
| Control Arm | Active comparator | Procedure: Routine Urethral Catheter TractionParticipants perform routine urethral catheter traction application on mannequins. Post-procedure, users complete the "Catheter Traction Procedure Evaluation Form". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Active operating room nurse or urology specialist physician.
- Experienced in urethral catheter application.
- Signed informed consent form voluntarily.
Key exclusion criteria (2 listed)
- Individuals who do not wish to participate or withdraw consent during the study.
- Individuals who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innovative Urethral Catheter Traction DeviceA 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. | Device | Intervention Arm |
| Routine Urethral Catheter TractionStandard 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. | Procedure or surgery | Control Arm |
Primary outcome
Ease of Application Between the Innovative and Routine Urethral Catheter Traction Methods
Time frame: Immediately after each intervention session (within 1 hour).
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.
1 secondary outcome
Stability and Safety of Catheter Traction Between the Innovative and Routine Methods
Time frame: Immediately after both intervention and control sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared. Data are limited and anonymized.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Urethral Catheter Traction Device and Routine Urethral Catheter Traction in people with Simulation Study on Urethral Catheter Traction for Postoperative Hemorrhage Control After TURP, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact özlem yılmaz, PhD (Candidate) (+90 05388906926, ozlem.yilmaz76@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Application Between the Innovative and Routine Urethral Catheter Traction Methods (time frame: Immediately after each intervention session (within 1 hour).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.