Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: High freqnence Irreversible electroporation; Procedure: 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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Haifeng Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age over 40 years old
2. IPSS>8
3. Qmax <15ml/s
4. Prostatic volume range of 30 to 100ml, measured by MRI
5. Fully understand the clinical trial protocol and sign the informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Freqnence Irreversible Electroporation; Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia	Procedure: High freqnence Irreversible electroporation; 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
Active Comparator: Trans Urethral Resection Prostate; Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia	Procedure: Trans Urethral Resection Prostate; Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum urinary flow rate(Qmax)	the change from baseline in maximum urinary flow rate(Qmax)	3 months after surgical treatment
urination function(evaluated by International prostate symptom score, IPSS)	the change from baseline in IPSS (International prostate symptom score)	3 months after surgical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain measured by a surgical pain scale	pain measured by a surgical pain scale range from 0 to 10	24 hours, 1 week, 1 month and 3 months
perioperative parameters(haemoglobin declination)	haemoglobin declination	6 hours, 24 hours after surgical treatment
perioperative parameters(serum sodium declination)	serum sodium declination	6 hours, 24 hours after surgical treatment
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)	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)	3 months after surgical treatment
post-void residual urine volume (PVRU)	the change from the baseline in the post-void residual urine volume (PVRU)	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)	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	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	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)	3 months after surgical treatment
perioperative parameters(operative time)	operative time	Day 0 (During surgical procedure)
perioperative parameters(the postoperative hospital stay)	the postoperative hospital stay	Up to hospital discharge (assessed up to 1 month)
perioperative parameters(catheterisation duration)	catheterisation duration	Up to catheter removal (assessed up to 1 month)
early postoperative urinary symptoms	include dysuria, urgency, or post micturition pain	3 months after surgical treatment
adverse event	including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation.	Up to 3 months after surgical treatment
voided volume	the change from the baseline in voided volume	3 months after surgical treatment

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Publications and helpful links

General Publications

• He 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): May 25, 2025
• Study Completion (Actual): May 25, 2025

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; High freqnence Irreversible electroporation; Trans Urethral Resection Prostate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: H-FIREBPH-2021001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD used in the results publication will be shared
• IPD Sharing Time Frame: IPD and supporting information will be available after the first relevant article is published and last for 10 years after the latest relevant article is published.
• IPD Sharing Access Criteria: Approvals need to be sort from the data custodians at the health services involved in line with China regulations
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No