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

SRS Medical Systems

Status

Completed

Conditions

Urinary Retention

Treatments

Device: The Spanner Temporary Prostatic Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT02643849

SRS 1.0

Details and patient eligibility

About

The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.

Enrollment

107 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.