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

Last updated: November 15, 2024
Sponsor: Shanghai East Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Bladder Disorders

Treatment

Trans Urethral Resection Prostate

High freqnence Irreversible electroporation

Clinical Study ID

NCT05306145
H-FIREBPH-2021001
  • Ages > 40
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Trans Urethral Resection Prostate
Phase:
Study Start date:
June 30, 2022
Estimated Completion Date:
April 01, 2026

Study 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.

Connect with a study center

  • Haifeng Wang

    Shanghai,
    China

    Active - Recruiting

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