The Expander-2 Trial: A Randomized Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Prostate, BPH, Benign, Minimally Invasive, Temporary Read More

Inclusion Criteria:

1. Subject has signed an informed consent form (ICF).
2. Men ≥ 45 years.

3. 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.
4. Prostate volume 30-80 cc.
5. 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:

1. Previous BPH procedure intended to disobstruct the bladder outlet.
2. Obstructive protruding (mobile) middle (median) prostatic lobe.
3. High bladder neck.
4. Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
5. Biopsy of the prostate within past 8 weeks.
6. Confirmed or suspected bladder cancer.
7. 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).
8. History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
9. History of neurogenic bladder.
10. Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
11. Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention.
12. Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).
13. 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).
14. Active infection including acute bacterial prostatitis.
15. Previous pelvic irradiation or radical pelvic surgery.