Bipolar Enucleation of the ProstateNCT07020325
Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
A study testing Bipolar Enucleation of the Prostate, Bipolar electrode From Wolf company and Bipolar electrode From Storz company in people with Bipolar Enucleation of the Prostate, run by Menoufia University.
Trial summary
The goal of this randomized, prospective, multicenter clinical trial is to compare the enucleation efficacy of prostate enucleation using different commercial bipolar electrodes in male patients aged ≥50 years diagnosed with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Bipolar Enucleation of the Prostate
- What is being tested?
- Bipolar Enucleation of the Prostate, Bipolar electrode From Wolf company and Bipolar electrode From Storz company
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 10 Mar 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years
- Diagnosed with moderate to severe LUTS due to BPH.
- Prostate size ≥40 g based on transrectal ultrasound (TRUS) or MRI.
- Ability to provide informed consent.
Who cannot join
- Prostate cancer.
- Urethral stricture disease.
- Patients with severe cardiac comorbidities or bleeding disorders.
- Patients on anticoagulation therapy.
About this study
The goal of this randomized, prospective, multicenter clinical trial is to compare the enucleation efficacy of prostate enucleation using different commercial bipolar electrodes in male patients aged ≥50 years diagnosed with benign prostatic hyperplasia (BPH). The main questions it aims to answer are:
Which bipolar electrode provides the most effective enucleation?
Read more
What are the safety and postoperative outcomes of different bipolar electrodes?
What are the intraoperative and postoperative complication rates for each electrode type?
How does the learning curve differ among different electrode types?
What is the cost-effectiveness of each electrode?
Researchers will compare four groups, each assigned a different commercial bipolar electrode (Electrode A, B, C, or D), to determine differences in efficacy, safety, and cost-effectiveness.
Participants will:
Undergo bipolar enucleation of the prostate performed by experienced surgeons.
Be randomized into one of four groups based on the electrode used.
Follow a standardized surgical technique across all centres.
Be monitored for intraoperative and postoperative outcomes over a 6-month follow-up period.
Data collection and analysis will be conducted by blinded investigators to ensure unbiased results.
- Conditions
- Bipolar Enucleation of the Prostate
- Being tested
- Bipolar Enucleation of the Prostate, Bipolar electrode From Wolf company, Bipolar electrode From Storz company, Bipolar electrode From Olympus company, Bipolar electrode From Lamidey company
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar Enucleation of the ProstateProcedure or surgery
Bipolar enucleation of the prostate involves the removal of prostate tissue using a bipolar electrode. This procedure is performed for patients with benign prostatic hyperplasia (BPH), with different electrode types used for comparison in this study
Bipolar electrode From Wolf companyDevice
This study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system.
Bipolar electrode From Storz companyDevice
This study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system.
Bipolar electrode From Olympus companyDevice
This study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system.
Bipolar electrode From Lamidey companyDevice
This study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Enucleation Using Electrode A (Company X) | Experimental | Participants will undergo prostate enucleation using Electrode A for BPH treatment. Receives: Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Wolf company |
| Bipolar Enucleation Using Electrode B (Company Y) | Experimental | Participants will undergo prostate enucleation using Electrode B for BPH treatment. Receives: Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Storz company |
| Bipolar Enucleation Using Electrode C (Company W) | Experimental | Bipolar Enucleation Using Electrode C (Company W) Receives: Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Olympus company |
| Bipolar Enucleation Using Electrode D (Company Z) | Experimental | Bipolar Enucleation Using Electrode D (Company Z) Receives: Procedure: Bipolar Enucleation of the Prostate; Device: Bipolar electrode From Lamidey company |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enucleation Efficiency (g/min) of Different Bipolar Electrodes
Enucleation efficiency will be calculated by dividing the enucleated tissue weight (grams) by the total enucleation time (minutes), providing a g/min value. This metric reflects the technical efficacy of the bipolar enucleation electrode in prostate tissue removal. Data will be compared across the four bipolar systems used in the study.
Measured: Time Frame: Intraoperative
Secondary outcomes (6)
Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)
Complications will be recorded and graded according to the Clavien-Dindo classification system. Events include, but are not limited to, bleeding requiring transfusion, urinary retention, infection, bladder injury, and incontinence. The frequency and severity of complications will be analyzed and compared between devices.
Unit of Measure: Number of adverse events per Clavien-Dindo grade.
Measured: Time Frame: Intraoperative and up to 30 days postoperative
Change in International Prostate Symptom Score (IPSS)
Description: Change from baseline in patient-reported urinary symptoms as measured by the International Prostate Symptom Score (IPSS) to evaluate symptom improvement after bipolar enucleation.
Unit of Measure: IPSS score (0-35)
Measured: Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative
Change in Maximum Flow Rate (Qmax)
Description: Change from baseline in maximum urinary flow rate to assess improvement in urinary flow after bipolar enucleation.
Unit of Measure: mL/second
Measured: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
Change in Post-Void Residual Volume (PVR)
Description: Change from baseline in post-void residual urine volume to evaluate bladder emptying efficiency after bipolar enucleation.
Unit of Measure: milliliters (mL)
Measured: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases
Surgeon learning curve will be assessed by measuring enucleation time (in minutes) across consecutive cases for each bipolar system. The trend in time reduction will be analyzed to evaluate the learning trajectory.
Unit of Measure: Enucleation time in minutes per case
Measured: During 12-month recruitment/study period
Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient
Total cost per patient will be calculated by summing surgical device costs, operating room time, length of hospital stay, and postoperative care costs (including catheter duration, readmissions, and complication-related expenses).
Unit of Measure: Cost in local currency (e.g., Euros or USD)
Measured: Time Frame: From procedure day to end of 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Enucleation of the ProstateStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a parallel design, where participants are randomly assigned to one of four intervention groups. Each group receives treatment with a specific type of commercial bipolar electrode. The study aims to assess differences in efficacy, safety, learning curve, and cost-effectiveness across the four electrode types. The surgical technique is standardized across all centers to minimize variability, and data collection is blinded to ensure objective analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Omar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020325
- Sponsor's protocol ID
- 2/2025 Urol
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Bipolar Enucleation of the Prostate Using Different Commercial Types of Electrodes
- ClinicalTrials.gov ID
- NCT07020325
- Acronym / sponsor ID
- 2/2025 Urol
- Conditions
- Bipolar Enucleation of the Prostate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 13 Jun 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.
The goal of this randomized, prospective, multicenter clinical trial is to compare the enucleation efficacy of prostate enucleation using different commercial bipolar electrodes in male patients aged ≥50 years diagnosed with benign prostatic hyperplasia (BPH). The main questions it aims to answer are:
Which bipolar electrode provides the most effective enucleation?
What are the safety and postoperative outcomes of different bipolar electrodes?
What are the intraoperative and postoperative complication rates for each electrode type?
How does the learning curve differ among different electrode types?
What is the cost-effectiveness of each electrode?
Researchers will compare four groups, each assigned a different commercial bipolar electrode (Electrode A, B, C, or D), to determine differences in efficacy, safety, and cost-effectiveness.
Participants will:
Undergo bipolar enucleation of the prostate performed by experienced surgeons.
Be randomized into one of four groups based on the electrode used.
Follow a standardized surgical technique across all centres.
Be monitored for intraoperative and postoperative outcomes over a 6-month follow-up period.
Data collection and analysis will be conducted by blinded investigators to ensure unbiased results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study follows a parallel design, where participants are randomly assigned to one of four intervention groups. Each group receives treatment with a specific type of commercial bipolar electrode. The study aims to assess differences in efficacy, safety, learning curve, and cost-effectiveness across the four electrode types. The surgical technique is standardized across all centers to minimize variability, and data collection is blinded to ensure objective analysis.
| Arm | Type | Receives |
|---|---|---|
| Bipolar Enucleation Using Electrode A (Company X) | Experimental | Procedure: Bipolar Enucleation of the Prostate, Device: Bipolar electrode From Wolf companyParticipants will undergo prostate enucleation using Electrode A for BPH treatment. |
| Bipolar Enucleation Using Electrode B (Company Y) | Experimental | Procedure: Bipolar Enucleation of the Prostate, Device: Bipolar electrode From Storz companyParticipants will undergo prostate enucleation using Electrode B for BPH treatment. |
| Bipolar Enucleation Using Electrode C (Company W) | Experimental | Procedure: Bipolar Enucleation of the Prostate, Device: Bipolar electrode From Olympus companyBipolar Enucleation Using Electrode C (Company W) |
| Bipolar Enucleation Using Electrode D (Company Z) | Experimental | Procedure: Bipolar Enucleation of the Prostate, Device: Bipolar electrode From Lamidey companyBipolar Enucleation Using Electrode D (Company Z) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥50 years
- Diagnosed with moderate to severe LUTS due to BPH.
- Prostate size ≥40 g based on transrectal ultrasound (TRUS) or MRI.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Prostate cancer.
- Urethral stricture disease.
- Patients with severe cardiac comorbidities or bleeding disorders.
- Patients on anticoagulation therapy.
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 |
|---|---|---|
| Bipolar Enucleation of the ProstateBipolar enucleation of the prostate involves the removal of prostate tissue using a bipolar electrode. This procedure is performed for patients with benign prostatic hyperplasia (BPH), with different electrode types used for comparison in this study | Procedure or surgery | Bipolar Enucleation Using Electrode A (Company X), Bipolar Enucleation Using Electrode B (Company Y), Bipolar Enucleation Using Electrode C (Company W), Bipolar Enucleation Using Electrode D (Company Z) |
| Bipolar electrode From Wolf companyThis study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system. | Device | Bipolar Enucleation Using Electrode A (Company X) |
| Bipolar electrode From Storz companyThis study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system. | Device | Bipolar Enucleation Using Electrode B (Company Y) |
| Bipolar electrode From Olympus companyThis study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system. | Device | Bipolar Enucleation Using Electrode C (Company W) |
| Bipolar electrode From Lamidey companyThis study involves bipolar transurethral resection of the prostate (TURP) using four different bipolar electrosurgical systems, each provided by a distinct manufacturer. The aim is to evaluate and compare the efficacy, safety, and clinical outcomes associated with each system. | Device | Bipolar Enucleation Using Electrode D (Company Z) |
Primary outcome
Enucleation Efficiency (g/min) of Different Bipolar Electrodes
Time frame: Time Frame: Intraoperative
Enucleation efficiency will be calculated by dividing the enucleated tissue weight (grams) by the total enucleation time (minutes), providing a g/min value. This metric reflects the technical efficacy of the bipolar enucleation electrode in prostate tissue removal. Data will be compared across the four bipolar systems used in the study.
6 secondary outcomes
Perioperative Safety: Incidence of Adverse Events (Clavien-Dindo Classification)
Time frame: Time Frame: Intraoperative and up to 30 days postoperative
Change in International Prostate Symptom Score (IPSS)
Time frame: Time Frame: Preoperative baseline, and at 6 weeks, 3 months, and 6 months postoperative
Change in Maximum Flow Rate (Qmax)
Time frame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
Change in Post-Void Residual Volume (PVR)
Time frame: Time Frame: Preoperative baseline, 6 weeks, 3 months, and 6 months postoperative
Learning Curve Assessment Based on Enucleation Time Over Consecutive Cases
Time frame: During 12-month recruitment/study period
Cost-Effectiveness: Total Procedure and Postoperative Cost per Patient
Time frame: Time Frame: From procedure day to end of 6-month follow-up
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 13 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar Enucleation of the Prostate, Bipolar electrode From Wolf company and Bipolar electrode From Storz company in people with Bipolar Enucleation of the Prostate, run by Menoufia University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enucleation Efficiency (g/min) of Different Bipolar Electrodes (time frame: Time Frame: Intraoperative). 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 13 Jun 2025.