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

Tongji University

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: Trans Urethral Resection Prostate; Procedure: High freqnence Irreversible electroporation

Study type: Interventional

Funder types: Other

Identifiers

NCT05306145

H-FIREBPH-2021001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups

High Freqnence Irreversible Electroporation

Experimental group

Description:

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

Treatment:

Procedure: High freqnence Irreversible electroporation

Trans Urethral Resection Prostate

Active Comparator group

Description:

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

Treatment:

Procedure: Trans Urethral Resection Prostate