Status:
UNKNOWN
Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
Lead Sponsor:
Changhai Hospital
Conditions:
Lower Urinary Tract Symptoms
Eligibility:
MALE
45+ years
Phase:
PHASE2
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, lu...
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 th...
Eligibility Criteria
Inclusion
- Male, 45 years or older.
- The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
- Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
- The presence of bladder outlet obstruction during pressure-flow study.
- International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
- Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
- Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
- Subject is able to communicate and complete the questionnaires properly.
- Written informed consent.
Exclusion
- Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
- Patients with arrhythmia or history of cardiac pacemaker implantation.
- Known lower urinary tract or pelvic surgical history.
- Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
- Known neurogenic or congenital lower urinary tract dysfunction.
- Rigid or flexible cystoscopy examination within the past 7 days at screening.
- Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
- The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
- Patients with poor compliance or cognitive competence.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03448510
Start Date
April 1 2018
End Date
May 30 2019
Last Update
February 28 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433