Benign Prostatic HyperplasiaNCT05306145
Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia
A study testing High freqnence Irreversible electroporation and Trans Urethral Resection Prostate in people with Benign Prostatic Hyperplasia, run by Shanghai East Hospital at 1 site in China.
Trial summary
This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- High freqnence Irreversible electroporation and Trans Urethral Resection Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 25 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 40 years old
- IPSS>8
- Qmax <15ml/s
- Prostatic volume range of 30 to 100ml, measured by MRI
- Fully understand the clinical trial protocol and sign the informed consent
Who cannot join
- Have a history of prostate cancer or patients suspicious of prostate cancer Neurogenic bladder Metal implants in their body Previous history of prostatic or urethral surgery With Catheterisation more than 2 weeks Any other conditions that investigator judges that participations who are not suitable for this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.
Read the detailed description
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- High freqnence Irreversible electroporation, Trans Urethral Resection Prostate
- Keywords
- Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High freqnence Irreversible electroporationProcedure or surgery
High freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia
Trans Urethral Resection ProstateProcedure or surgery
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
| Study group | Role | What they receive |
|---|---|---|
| High Freqnence Irreversible Electroporation | Experimental | Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia Receives: Procedure: High freqnence Irreversible electroporation |
| Trans Urethral Resection Prostate | Active comparator | Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia Receives: Procedure: Trans Urethral Resection Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum urinary flow rate(Qmax)
the change from baseline in maximum urinary flow rate(Qmax)
Measured: 3 months after surgical treatment
urination function(evaluated by International prostate symptom score, IPSS)
the change from baseline in IPSS (International prostate symptom score)
Measured: 3 months after surgical treatment
Secondary outcomes (16)
sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)
the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)
Measured: 3 months after surgical treatment
sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
Measured: 3 months after surgical treatment
post-void residual urine volume (PVRU)
the change from the baseline in the post-void residual urine volume (PVRU)
Measured: 3 months after surgical treatment
urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)
Measured: 3 months after surgical treatment
urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
the change from the baseline in urinary incontinence, evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
Measured: 3 months after surgical treatment
quality of life (QOL) evaluated by IPSS QoL subscore
the change from the baseline in QOL, evaluated by IPSS QoL subscore
Measured: 3 months after surgical treatment
quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS)
Measured: 3 months after surgical treatment
perioperative parameters(operative time)
operative time
Measured: Day 0 (During surgical procedure)
perioperative parameters(the postoperative hospital stay)
the postoperative hospital stay
Measured: Up to hospital discharge (assessed up to 1 month)
perioperative parameters(haemoglobin declination)
haemoglobin declination
Measured: 6 hours, 24 hours after surgical treatment
perioperative parameters(serum sodium declination)
serum sodium declination
Measured: 6 hours, 24 hours after surgical treatment
perioperative parameters(catheterisation duration)
catheterisation duration
Measured: Up to catheter removal (assessed up to 1 month)
early postoperative urinary symptoms
include dysuria, urgency, or post micturition pain
Measured: 3 months after surgical treatment
pain measured by a surgical pain scale
pain measured by a surgical pain scale range from 0 to 10
Measured: 24 hours, 1 week, 1 month and 3 months
adverse event
including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation.
Measured: Up to 3 months after surgical treatment
voided volume
the change from the baseline in voided volume
Measured: 3 months after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start30 Jun 2022
- Primary completion25 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306145
- Sponsor's protocol ID
- H-FIREBPH-2021001
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be shared
Publications
He BM, Li RB, Li DY, Huang LQ, Jin ZC, Shi ZK, Wang SD, Lu JS, Wen JL, Wang HF. High-frequency irreversible electroporation versus transurethral resection of the prostate for benign prostatic hyperplasia (GIANT): a single-centre, randomised, double-blind, phase 3, non-inferiority trial. EClinicalMedicine. 2026 Jul 2;97:104034. doi: 10.1016/j.eclinm.2026.104034. eCollection 2026 Jul.
PubMed 42433275He BM, Shi ZK, Chen R, Wang HF. Study protocol for a single-centre non-inferior double-blinded randomised controlled trial in China comparing the efficacy and safety of high-frequency irreversible electroporation with transurethral resection of the prostate in treating lower urinary tract symptoms and benign prostatic obstruction (the GIANT trial). BMJ Open. 2025 Jan 9;15(1):e092489. doi: 10.1136/bmjopen-2024-092489.
PubMed 39788775
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05306145
- Acronym / sponsor ID
- H-FIREBPH-2021001
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 31 Mar 2022 (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.
This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.
Detailed description
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Freqnence Irreversible Electroporation | Experimental | Procedure: High freqnence Irreversible electroporationUsing high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia |
| Trans Urethral Resection Prostate | Active comparator | Procedure: Trans Urethral Resection ProstateUsing trans urethral resection prostate to treat patients with benign prostatic hyperplasia |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 40 years old
- IPSS>8
- Qmax <15ml/s
- Prostatic volume range of 30 to 100ml, measured by MRI
- Fully understand the clinical trial protocol and sign the informed consent
Key exclusion criteria (1 listed)
- Have a history of prostate cancer or patients suspicious of prostate cancer Neurogenic bladder Metal implants in their body Previous history of prostatic or urethral surgery With Catheterisation more than 2 weeks Any other conditions that investigator judges that participations who are not suitable for this trial
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 |
|---|---|---|
| High freqnence Irreversible electroporationHigh freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia | Procedure or surgery | High Freqnence Irreversible Electroporation |
| Trans Urethral Resection ProstateTrans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic | Procedure or surgery | Trans Urethral Resection Prostate |
Primary outcome
maximum urinary flow rate(Qmax)
Time frame: 3 months after surgical treatment
the change from baseline in maximum urinary flow rate(Qmax)
urination function(evaluated by International prostate symptom score, IPSS)
Time frame: 3 months after surgical treatment
the change from baseline in IPSS (International prostate symptom score)
16 secondary outcomes
sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)
Time frame: 3 months after surgical treatment
sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
Time frame: 3 months after surgical treatment
post-void residual urine volume (PVRU)
Time frame: 3 months after surgical treatment
urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
Time frame: 3 months after surgical treatment
urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
Time frame: 3 months after surgical treatment
quality of life (QOL) evaluated by IPSS QoL subscore
Time frame: 3 months after surgical treatment
quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
Time frame: 3 months after surgical treatment
perioperative parameters(operative time)
Time frame: Day 0 (During surgical procedure)
perioperative parameters(the postoperative hospital stay)
Time frame: Up to hospital discharge (assessed up to 1 month)
perioperative parameters(haemoglobin declination)
Time frame: 6 hours, 24 hours after surgical treatment
perioperative parameters(serum sodium declination)
Time frame: 6 hours, 24 hours after surgical treatment
perioperative parameters(catheterisation duration)
Time frame: Up to catheter removal (assessed up to 1 month)
early postoperative urinary symptoms
Time frame: 3 months after surgical treatment
pain measured by a surgical pain scale
Time frame: 24 hours, 1 week, 1 month and 3 months
adverse event
Time frame: Up to 3 months after surgical treatment
voided volume
Time frame: 3 months after surgical treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 42433275He BM, Li RB, Li DY, Huang LQ, Jin ZC, Shi ZK, Wang SD, Lu JS, Wen JL, Wang HF. High-frequency irreversible electroporation versus transurethral resection of the prostate for benign prostatic hyperplasia (GIANT): a single-centre, randomised, double-blind, phase 3, non-inferiority trial. EClinicalMedicine. 2026 Jul 2;97:104034. doi: 10.1016/j.eclinm.2026.104034. eCollection 2026 Jul.
- Derived from this study: PubMed 39788775He BM, Shi ZK, Chen R, Wang HF. Study protocol for a single-centre non-inferior double-blinded randomised controlled trial in China comparing the efficacy and safety of high-frequency irreversible electroporation with transurethral resection of the prostate in treating lower urinary tract symptoms and benign prostatic obstruction (the GIANT trial). BMJ Open. 2025 Jan 9;15(1):e092489. doi: 10.1136/bmjopen-2024-092489.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be shared
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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. This study is not recruiting at the moment.
Haifeng Wang principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High freqnence Irreversible electroporation and Trans Urethral Resection Prostate in people with Benign Prostatic Hyperplasia, run by Shanghai East Hospital at 1 site in China.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 5 May 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum urinary flow rate(Qmax) (time frame: 3 months after surgical treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306145, which also lists 2 linked publications.
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 5 May 2026.