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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High freqnence Irreversible electroporation
Trans Urethral Resection Prostate
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    High Freqnence Irreversible Electroporation

    Trans Urethral Resection Prostate

    Arm Description

    Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia

    Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia

    Outcomes

    Primary Outcome Measures

    maximum urinary flow rate(Qmax)
    the change from baseline in maximum urinary flow rate(Qmax)
    urination function(evaluated by International prostate symptom score, IPSS)
    the change from baseline in IPSS (International prostate symptom score)

    Secondary Outcome Measures

    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)
    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)
    post-void residual urine volume (PVRU)
    the post-void residual urine volume (PVRU) and the change from the baseline
    urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
    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
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    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
    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
    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
    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
    quality of life (QOL) evaluated by IPSS QoL subscore
    evaluated by IPSS QoL subscore
    quality of life (QOL) evaluated by IPSS QoL subscore
    evaluated by IPSS QoL subscore
    quality of life (QOL) evaluated by IPSS QoL subscore
    evaluated by IPSS QoL subscore
    quality of life (QOL) evaluated by IPSS QoL subscore
    evaluated by IPSS QoL subscore
    quality of life (QOL) evaluated by IPSS QoL subscore
    evaluated by IPSS QoL subscore
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    perioperative parameters(operative time)
    operative time
    perioperative parameters(the postoperative hospital stay)
    the postoperative hospital stay
    perioperative parameters(haemoglobin declination)
    haemoglobin declination
    perioperative parameters(serum sodium declination)
    serum sodium declination
    perioperative parameters(catheterisation duration)
    catheterisation duration
    early postoperative urinary symptoms
    include dysuria, urgency, or post micturition pain
    pain measured by a surgical pain scale
    pain measured by a surgical pain scale range from 0 to 10
    adverse event
    including TUR syndrome, blood transfusion, clot retention, uti, transient incontience.

    Full Information

    First Posted
    March 7, 2022
    Last Updated
    May 30, 2022
    Sponsor
    Shanghai East Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05306145
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2028 (Anticipated)
    Study Completion Date
    October 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai East Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Freqnence Irreversible Electroporation
    Arm Type
    Experimental
    Arm Description
    Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia
    Arm Title
    Trans Urethral Resection Prostate
    Arm Type
    Active Comparator
    Arm Description
    Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia
    Intervention Type
    Procedure
    Intervention Name(s)
    High freqnence Irreversible electroporation
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Trans Urethral Resection Prostate
    Intervention Description
    Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
    Primary Outcome Measure Information:
    Title
    maximum urinary flow rate(Qmax)
    Description
    the change from baseline in maximum urinary flow rate(Qmax)
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Title
    urination function(evaluated by International prostate symptom score, IPSS)
    Description
    the change from baseline in IPSS (International prostate symptom score)
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Secondary Outcome Measure Information:
    Title
    sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)
    Description
    the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Title
    sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
    Description
    the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Title
    post-void residual urine volume (PVRU)
    Description
    the post-void residual urine volume (PVRU) and the change from the baseline
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Title
    urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
    Description
    the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)
    Time Frame
    1, 3, 6, 12 and 24 months after surgical treatment
    Title
    urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Description
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Time Frame
    1 month after surgical treatment.
    Title
    urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Description
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Time Frame
    3 months after surgical treatment.
    Title
    urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Description
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Time Frame
    6 months after surgical treatment.
    Title
    urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Description
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Time Frame
    12 months after surgical treatment.
    Title
    urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Description
    evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
    Time Frame
    24 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by IPSS QoL subscore
    Description
    evaluated by IPSS QoL subscore
    Time Frame
    1 month after surgical treatment.
    Title
    quality of life (QOL) evaluated by IPSS QoL subscore
    Description
    evaluated by IPSS QoL subscore
    Time Frame
    3 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by IPSS QoL subscore
    Description
    evaluated by IPSS QoL subscore
    Time Frame
    6 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by IPSS QoL subscore
    Description
    evaluated by IPSS QoL subscore
    Time Frame
    12 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by IPSS QoL subscore
    Description
    evaluated by IPSS QoL subscore
    Time Frame
    24 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    Description
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    1 month after surgical treatment.
    Title
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    Description
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    3 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    Description
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    6 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    Description
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    12 months after surgical treatment.
    Title
    quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
    Description
    evaluated by Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    24 months after surgical treatment.
    Title
    perioperative parameters(operative time)
    Description
    operative time
    Time Frame
    1 month
    Title
    perioperative parameters(the postoperative hospital stay)
    Description
    the postoperative hospital stay
    Time Frame
    1 month
    Title
    perioperative parameters(haemoglobin declination)
    Description
    haemoglobin declination
    Time Frame
    1 month
    Title
    perioperative parameters(serum sodium declination)
    Description
    serum sodium declination
    Time Frame
    1 month
    Title
    perioperative parameters(catheterisation duration)
    Description
    catheterisation duration
    Time Frame
    1 month
    Title
    early postoperative urinary symptoms
    Description
    include dysuria, urgency, or post micturition pain
    Time Frame
    6 months
    Title
    pain measured by a surgical pain scale
    Description
    pain measured by a surgical pain scale range from 0 to 10
    Time Frame
    24 hours, 1 week, 1 month and 3 months
    Title
    adverse event
    Description
    including TUR syndrome, blood transfusion, clot retention, uti, transient incontience.
    Time Frame
    any of the time within 6 months after surgical treatment

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 40 years Qmax<15mL/s IPSS score >8 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Biming He
    Phone
    +8615502139410
    Email
    190589109@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haifeng Wang
    Phone
    +8613681750891
    Email
    446720864@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haifeng Wang
    Organizational Affiliation
    Shanghai East Hospital,Tongji University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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