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NCT Number: NCT05306145

Comparison of H-FIRE and TURP in Treating 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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Haifeng Wang

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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

Trans Urethral Resection Prostate

Procedure

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

Primary outcomes

  1. maximum urinary flow rate(Qmax)

    Time frame: 3 months after surgical treatment

    the change from baseline in maximum urinary flow rate(Qmax)

  2. urination function(evaluated by International prostate symptom score, IPSS)

    Time frame: 3 months after surgical treatment

    the change from baseline in IPSS (International prostate symptom score)

Secondary outcomes

  1. sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)

    Time frame: 3 months after surgical treatment

    the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)

  2. sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)

    Time frame: 3 months after surgical treatment

    the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)

  3. post-void residual urine volume (PVRU)

    Time frame: 3 months after surgical treatment

    the change from the baseline in the post-void residual urine volume (PVRU)

  4. urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)

    Time frame: 3 months after surgical treatment

    the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)

  5. urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item

    Time frame: 3 months after surgical treatment

    the change from the baseline in urinary incontinence, evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item

  6. quality of life (QOL) evaluated by IPSS QoL subscore

    Time frame: 3 months after surgical treatment

    the change from the baseline in QOL, evaluated by IPSS QoL subscore

  7. quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))

    Time frame: 3 months after surgical treatment

    the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS)

  8. perioperative parameters(operative time)

    Time frame: Day 0 (During surgical procedure)

    operative time

  9. perioperative parameters(the postoperative hospital stay)

    Time frame: Up to hospital discharge (assessed up to 1 month)

    the postoperative hospital stay

  10. perioperative parameters(haemoglobin declination)

    Time frame: 6 hours, 24 hours after surgical treatment

    haemoglobin declination

  11. perioperative parameters(serum sodium declination)

    Time frame: 6 hours, 24 hours after surgical treatment

    serum sodium declination

  12. perioperative parameters(catheterisation duration)

    Time frame: Up to catheter removal (assessed up to 1 month)

    catheterisation duration

  13. early postoperative urinary symptoms

    Time frame: 3 months after surgical treatment

    include dysuria, urgency, or post micturition pain

  14. pain measured by a surgical pain scale

    Time frame: 24 hours, 1 week, 1 month and 3 months

    pain measured by a surgical pain scale range from 0 to 10

  15. adverse event

    Time frame: Up to 3 months after surgical treatment

    including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation.

  16. voided volume

    Time frame: 3 months after surgical treatment

    the change from the baseline in voided volume

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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