Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia
NCT ID: NCT05306145
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2022-06-30
2026-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High Freqnence Irreversible Electroporation
Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia
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
Trans Urethral Resection Prostate
Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia
Trans Urethral Resection Prostate
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
Interventions
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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
Trans Urethral Resection Prostate
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
Eligibility Criteria
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Inclusion Criteria
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
40 Years
MALE
Yes
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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Haifeng Wang
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital,Tongji University School of Medicine
Locations
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Haifeng Wang
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Haifeng Wang
Role: primary
References
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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.
Other Identifiers
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H-FIREBPH-2021001
Identifier Type: -
Identifier Source: org_study_id
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