Comparison of H-FIRE & TURP in Treating Benign Prostatic NCT05306145

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number	NCT05306145
Other study ID #	H-FIREBPH-2021001
Secondary ID
Status	Not yet recruiting
Phase	N/A
First received
Last updated
Start date	July 1, 2022
Est. completion date	October 1, 2028

Study information
Verified date	May 2022
Source	Shanghai East Hospital
Contact	Biming He
Phone	+8615502139410
Email	190589109[@]qq.com
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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 1, 3, 6, 12, 24, 36, 48 and 60 months after surgical treatment.

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	176
Est. completion date	October 1, 2028
Est. primary completion date	July 1, 2028
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Male
Age group	40 Years and older
Eligibility	Inclusion Criteria: 1. Age = 40 years 2. Qmax<15mL/s 3. IPSS score >8 4. prostatic volume range of 30 to 100ml Exclusion Criteria: Patients with history of prostate cancer or patiens suspicious to have prostate cancer. Patients with neurogenic bladder. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs. patiens with previous history of prostatic or urethral surgery Patients with the judge that they are not suitable for this clinical trial

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• High freqnence Irreversible electroporation
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
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Shanghai East Hospital

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Outcome

Type	Measure	Description	Time frame
Primary	maximum urinary flow rate(Qmax)	the change from baseline in maximum urinary flow rate(Qmax)	1, 3, 6, 12 and 24 months after surgical treatment
Primary	urination function(evaluated by International prostate symptom score, IPSS)	the change from baseline in IPSS (International prostate symptom score)	1, 3, 6, 12 and 24 months after surgical treatment
Secondary	sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)	the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)	1, 3, 6, 12 and 24 months after surgical treatment
Secondary	sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)	the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)	1, 3, 6, 12 and 24 months after surgical treatment
Secondary	post-void residual urine volume (PVRU)	the post-void residual urine volume (PVRU) and the change from the baseline	1, 3, 6, 12 and 24 months after surgical treatment
Secondary	urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)	the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)	1, 3, 6, 12 and 24 months after surgical treatment
Secondary	urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	1 month after surgical treatment.
Secondary	urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	3 months after surgical treatment.
Secondary	urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	6 months after surgical treatment.
Secondary	urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	12 months after surgical treatment.
Secondary	urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item	24 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by IPSS QoL subscore	evaluated by IPSS QoL subscore	1 month after surgical treatment.
Secondary	quality of life (QOL) evaluated by IPSS QoL subscore	evaluated by IPSS QoL subscore	3 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by IPSS QoL subscore	evaluated by IPSS QoL subscore	6 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by IPSS QoL subscore	evaluated by IPSS QoL subscore	12 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by IPSS QoL subscore	evaluated by IPSS QoL subscore	24 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	evaluated by Hospital Anxiety and Depression Scale (HADS)	1 month after surgical treatment.
Secondary	quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	evaluated by Hospital Anxiety and Depression Scale (HADS)	3 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	evaluated by Hospital Anxiety and Depression Scale (HADS)	6 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	evaluated by Hospital Anxiety and Depression Scale (HADS)	12 months after surgical treatment.
Secondary	quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))	evaluated by Hospital Anxiety and Depression Scale (HADS)	24 months after surgical treatment.
Secondary	perioperative parameters(operative time)	operative time	1 month
Secondary	perioperative parameters(the postoperative hospital stay)	the postoperative hospital stay	1 month
Secondary	perioperative parameters(haemoglobin declination)	haemoglobin declination	1 month
Secondary	perioperative parameters(serum sodium declination)	serum sodium declination	1 month
Secondary	perioperative parameters(catheterisation duration)	catheterisation duration	1 month
Secondary	early postoperative urinary symptoms	include dysuria, urgency, or post micturition pain	6 months
Secondary	pain measured by a surgical pain scale	pain measured by a surgical pain scale range from 0 to 10	24 hours, 1 week, 1 month and 3 months
Secondary	adverse event	including TUR syndrome, blood transfusion, clot retention, uti, transient incontience.	any of the time within 6 months after surgical treatment