Clinical Trials

Inclusion Criteria:

• Subject has signed an informed consent form (ICF).
• Men ≥ 45 years.
• Symptomatic BPH with the following (all must be met):
  • IPSS ≥ 13;
  • Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL;
  • PVR < 250 mL.
• Prostate volume 30-80 cc.
• Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day.

Exclusion Criteria:

Subjects who meet ANY of the following exclusion criteria will not participate in the
trial:

• Previous BPH procedure intended to disobstruct the bladder outlet.
• Obstructive protruding (mobile) middle (median) prostatic lobe.
• High bladder neck.
• Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
• Biopsy of the prostate within past 8 weeks.
• Confirmed or suspected bladder cancer.
• Confirmed or suspected prostate cancer.
  • Note: Subjects with suspected prostate cancer with a Prostate Specific Antigen (PSA) level > 2.5 ng/mL and ≤ 10 ng/mL with their free PSA < 25% of total PSA, must undergo a biopsy to rule out the diagnosis of prostate cancer. If biopsy is performed, and subject has no cancer, a waiting period of 8 weeks is required prior to randomization (see exclusion criterion 7). 
• History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
• History of neurogenic bladder.
• Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
• Previous episode of Acute Urinary Retention (AUR); i.e., post hernia repair or other condition or disease that might cause urinary retention.
• Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).
• Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a negative urine culture), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).
• Active infection including acute bacterial prostatitis.
• Previous pelvic irradiation or radical pelvic surgery.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/23/23. Questions regarding updates should be directed to the study team contact.