Clinical trial NCT01775488: Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
Official title: Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign Prostatic Hyperplasia
BPH
LUTS
Vortx Rx
Histotripsy
Lead sponsor: HistoSonics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy device. The purpose of this study is to assess and monitor the performance of the Vortx Rx for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of BPH and eligible for endoscopic BPH surgery including Transurethral Resection of the Prostate \[TURP\], PVP, electrovaporization
2. Prostate volumes 30 - 80 gm based on transrectal ultrasound
3. Men ≥ 50 years of age
4. IPSS symptom score \> 15 and IPSS bother score \> 2
5. Baseline peak flow rate Qmax \< 12 cc/s on two separate occasions with voided volume at least 150 cc

Exclusion Criteria:

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine \> 1.4)
2. Neurogenic bladder, Parkinson's disease
3. Prior treatment for urinary incontinence
4. Micturition frequency AND urgency. Micturition frequency defined as \> 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // \< 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs \> 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?"
5. Intravesical prostate lobe protrusion \> 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe
6. Active Urinary Tract Infection \[UTI\] (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)
7. PVR \> 250 at time of enrollment or catheter dependent bladder drainage
8. History of chronic prostatitis within the last 5 years
9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment
10. History of known bleeding disorders (e.g. von Willebrand disease)
11. Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy \[TUMT\], TUNA, water induced thermotherapy, TURP, PVP)
12. Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA \> 10 ng/mL. Men with free PSA \< 25% and with PSA within an age and race-specific range may only be enrolled after a negative biopsy. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is deemed eligible to participate in the study.
13. Men interested in future fertility
14. Declines or unable to provide informed consent
15. Non-English-speaker
16. Life expectancy estimated to be less than one year
17. Unable or unwilling to complete all required questionnaires and follow-up assessments
18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 6 months
Secondary outcomes:
measure: Assess initial prostate histotripsy treatment efficacy
timeFrame: Up to six months
Other outcomes:
Locations:
Study officials:
References: