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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Trans Urethral Resection Prostate; Procedure: High freqnence Irreversible electroporation

• Registration Number: NCT05306145
• Lead Sponsor: Shanghai East Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-06-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans Urethral Resection Prostate	Trans Urethral Resection Prostate	Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia
High Freqnence Irreversible Electroporation	High freqnence Irreversible electroporation	Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia

Primary Outcome Measures

Name	Time	Method
maximum urinary flow rate(Qmax)	1 and 3 months after surgical treatment	the change from baseline in maximum urinary flow rate(Qmax)
urination function(evaluated by International prostate symptom score, IPSS)	1 and 3 months after surgical treatment	the change from baseline in IPSS (International prostate symptom score)

Secondary Outcome Measures

Name	Time	Method
early postoperative urinary symptoms	1 and 3 months after surgical treatment	include dysuria, urgency, or post micturition pain
pain measured by a surgical pain scale	24 hours, 1 week, 1 month and 3 months	pain measured by a surgical pain scale range from 0 to 10
perioperative parameters(serum sodium declination)	6 hours, 24 hours after surgical treatment	serum sodium declination
perioperative parameters(catheterisation duration)	1 month	catheterisation duration
adverse event	1 and 3 months after surgical treatment	including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation.
voided volume	1 and 3 months after surgical treatment	the change from the baseline in voided volume
sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)	1 and 3 months after surgical treatment	the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)
sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)	1 and 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)
post-void residual urine volume (PVRU)	1 and 3 months after surgical treatment	the change from the baseline in the post-void residual urine volume (PVRU)
urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)	1 and 3 months after surgical treatment	the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)
urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	1 and 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
quality of life (QOL) evaluated by IPSS QoL subscore	1 and 3 months after surgical treatment	the change from the baseline in QOL, evaluated by IPSS QoL subscore
quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	1 and 3 months after surgical treatment	the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS)
perioperative parameters(operative time)	1 month	operative time
perioperative parameters(the postoperative hospital stay)	1 month	the postoperative hospital stay
perioperative parameters(haemoglobin declination)	6 hours, 24 hours after surgical treatment	haemoglobin declination

Trial Locations

Locations (1)

Haifeng Wang; 🇨🇳 Shanghai, China