Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men

Inclusion Criteria:

- Age > 45 years;

- In urinary retention and catheterized (indwelling or intermittent) for less than 180
days;

- Documented diagnostic history (within 180 days of study) of detrusor contractility (>=
15 cmH2O) confirmed via pressure-flow test;

- Negative Urinalysis on Visit 1;

- Not a candidate for pharmacologic, minimally invasive or surgical treatment of the
prostate;

- Charlson Weighted Index of Comorbidity Score >= 1;

- Willing and able to sign the Informed Consent Form;

- Willing and able to complete the follow-up protocol requirements;

- Experiencing catheter-induced discomfort.

Exclusion Criteria:

- Current use of a urinary catheter daily for greater than 180 consecutive days
immediately preceding entering into the study;

- Positive Urinalysis on Visit 1;

- Current or recent (within the last 6 months) urinary tract disease including urethral
stricture, bladder stones, and other significant urological conditions or surgery;

- Surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that
affect the function of the lower urinary tract;

- History of conditions associated with neurogenic bladder, including spinal cord
injury, multiple sclerosis, or Parkinson's disease;

- Use of anticholinergic medication;

- Gross hematuria when catheter is removed on Visit 1;

- Known or suspected prostate cancer;

- Prior pelvic irradiation therapy;

- Prostatic urethral length < 4 cm or > 9 cm (combined length from the top proximal side
of the bladder neck to the bottom distal side of the external sphincter);

- Intravesical enlargement of the median lobe of the prostate.