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

NCT05306145 | Completed DMC

• 1 other identifier: H-FIREBPH-2021001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; High freqnence Irreversible electroporation; Trans Urethral Resection Prostate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• sexual function evaluated by 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)

  3 months after surgical treatment

• post-void residual urine volume (PVRU)

  3 months after surgical treatment

• urinary incontinence evaluated 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

  3 months after surgical treatment

Study Arms (2)

High Freqnence Irreversible Electroporation

EXPERIMENTAL

Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia

Procedure: High freqnence Irreversible electroporation

Trans Urethral Resection Prostate

ACTIVE COMPARATOR

Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia

Procedure: Trans Urethral Resection Prostate

Interventions

High freqnence Irreversible electroporation PROCEDURE

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

High Freqnence Irreversible Electroporation

Trans Urethral Resection Prostate PROCEDURE

Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic

Trans Urethral Resection Prostate

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Haifeng Wang

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 39788775 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Haifeng Wang

  Shanghai East Hospital,Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 31, 2022
• Study Start: June 30, 2022
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: May 5, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Approvals need to be sort from the data custodians at the health services involved in line with China regulations

Locations

CN (1)