Clinical trial NCT05306145: Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
High freqnence Irreversible electroporation
Trans Urethral Resection Prostate
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 118
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: maximum urinary flow rate(Qmax)
timeFrame: 1 and 3 months after surgical treatment
measure: urination function(evaluated by International prostate symptom score, IPSS)
timeFrame: 1 and 3 months after surgical treatment
Secondary outcomes:
measure: sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)
timeFrame: 1 and 3 months after surgical treatment
measure: sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
timeFrame: 1 and 3 months after surgical treatment
measure: post-void residual urine volume (PVRU)
timeFrame: 1 and 3 months after surgical treatment
measure: urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
timeFrame: 1 and 3 months after surgical treatment
measure: urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
timeFrame: 1 and 3 months after surgical treatment
measure: quality of life (QOL) evaluated by IPSS QoL subscore
timeFrame: 1 and 3 months after surgical treatment
measure: quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
timeFrame: 1 and 3 months after surgical treatment
measure: perioperative parameters(operative time)
timeFrame: 1 month
measure: perioperative parameters(the postoperative hospital stay)
timeFrame: 1 month
measure: perioperative parameters(haemoglobin declination)
timeFrame: 6 hours, 24 hours after surgical treatment
measure: perioperative parameters(serum sodium declination)
timeFrame: 6 hours, 24 hours after surgical treatment
measure: perioperative parameters(catheterisation duration)
timeFrame: 1 month
measure: early postoperative urinary symptoms
timeFrame: 1 and 3 months after surgical treatment
measure: pain measured by a surgical pain scale
timeFrame: 24 hours, 1 week, 1 month and 3 months
measure: adverse event
timeFrame: 1 and 3 months after surgical treatment
measure: voided volume
timeFrame: 1 and 3 months after surgical treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Haifeng Wang
Study officials:
affiliation: Shanghai East Hospital,Tongji University School of Medicine
name: Haifeng Wang
role: PRINCIPAL_INVESTIGATOR
References: