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Trial record 11 of 272 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction

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ClinicalTrials.gov Identifier: NCT03448510
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yinghao Sun, Changhai Hospital

Brief Summary:
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Device: Irreversible electroporation Drug: Standard Medication Phase 2

Detailed Description:

Benign prostatic obstruction (BPO) is the main reason to cause lower urinary tract symptoms (LUTS) in aged male. Oral medications, such as,α1-adrenoceptor antagonist and 5α-reductase inhibitors are the mainstay treatment options. However, some patients can not tolerate long-term use, due to either side effects or limited efficacy. Though transurethral resection or enucleation of prostate usually achieve significant symptom improvement, it's an end stage procedure and it is only reserved for carefully selected patients.

The development of focal ablative therapy yields minimally invasive treatment option for primary tumors such as the liver, lung, pancreas, kidney, and prostate. Among the novel techniques are cryoablation, radiofrequency ablation (RFA), microwave ablation, and high-intensity focused ultrasonography. Irreversible electroporation (IRE) is a one of the ablation modalities using electric pulses to create nanoscale defects in the cell membrane. IRE is not dependent on thermal energy and is therefore causing minimum damage to the blood vessels, nerves and tissue architecture. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Masking: Single (Outcomes Assessor)
Masking Description: The data will be analyzed in a blinded manner.
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Irreversible electroporation treatment
Subjects will receive irreversible electroporation of the prostate
Device: Irreversible electroporation
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.

Active Comparator: standard medication group
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Drug: Standard Medication
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.




Primary Outcome Measures :
  1. The changes of maximum flow rate (ml/s) between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]
    Maximum flow rate will be measured using urinary flow study


Secondary Outcome Measures :
  1. The changes of IPSS scores between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]
    Measured using a standard IPSS scoring system

  2. The changes of IIEF scores between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]
    Measured using a standard IIEF scoring system

  3. The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up [ Time Frame: Measured at baseline and 3, 6 months during follow-up ]
    The data will be captured during pressure flow study

  4. The changes of post void residual volume (ml) between baseline and follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]
    Post void residual volume (ml) will be measured via ultrasound

  5. The changes of prostate volume (ml) between baseline and follow-up [ Time Frame: Measured at baseline and 1, 3, 6 during follow-up ]
    Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male, 45 years or older.
  2. The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
  3. Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
  4. The presence of bladder outlet obstruction during pressure-flow study.
  5. International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
  6. Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
  7. Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
  8. Subject is able to communicate and complete the questionnaires properly.
  9. Written informed consent.

Exclusion Criteria:

  1. Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
  2. Patients with arrhythmia or history of cardiac pacemaker implantation.
  3. Known lower urinary tract or pelvic surgical history.
  4. Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
  5. Known neurogenic or congenital lower urinary tract dysfunction.
  6. Rigid or flexible cystoscopy examination within the past 7 days at screening.
  7. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
  8. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
  9. Patients with poor compliance or cognitive competence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448510


Locations
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China, Shanghai
Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Haifeng Wang, MD, PhD    13681750891    446720864@qq.com   
Contact: Qi-Xiang Song, MD, PhD    15021223013    rex_song918@qq.com   
Sponsors and Collaborators
Changhai Hospital
  Study Documents (Full-Text)

Documents provided by Yinghao Sun, Changhai Hospital:
Study Protocol  [PDF] February 12, 2018


Publications:
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Responsible Party: Yinghao Sun, MD, PhD, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03448510     History of Changes
Other Study ID Numbers: IRE-2018
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yinghao Sun, Changhai Hospital:
lower urinary tract symptoms
male
benign prostatic obstruction
irreversible electroporation
urodynamics

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms