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 by transrectal ultrasound (TRUS), in the absence of magnetic resonance imaging (MRI), or TRUS measured within 6 months prior to randomization.
• Subjects 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 (see Table 1 for washout requirements per medication).

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 (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
• Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
• High bladder neck as determined by the Investigator.
• 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;
• Baseline Prostate Specific Antigen (PSA) level > 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level > 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making [SDM] with the study subjects).
• Confirmed or suspected bladder cancer.
• History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
• History of neurogenic bladder.
• Previous episode of Acute Urinary Retention (AUR) (i.e., post hernia repair), or other condition or disease that might cause urinary retention.
• Parkinson’s disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
• 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.
• Known allergy to nickel.
• Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
• Desire to maintain fertility post-treatment.
• Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
• Prostatic urethral length < 25 mm or > 60 mm, as measured from bladder neck to verumontanum, using cystoscopy at screening. Prostatic urethral length, if measured from bladder neck to verumontanum by TRUS and/or cystoscopy within the last 6 months prior to randomization is acceptable.
• Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:
  • severe cardiac arrhythmias uncontrolled by medications or pacemaker;
  • congestive heart failure New York Heart Association (NYHA) III or IV;
  • uncontrolled diabetes mellitus;
  • significant respiratory disease in which hospitalization may be required;
  • known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy).
• Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.
  • Note: Low dose aspirin therapy is acceptable.
• Unable or unwilling to complete all required questionnaires and follow-up assessments.
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
• Subject is in custody or institution, or, in the Investigator's opinion, has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).

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

Eligibility last updated 8/24/23. Questions regarding updates should be directed to the study team contact.