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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Spanner	The Spanner Temporary Prostatic Stent	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days	90 days	To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days	30 days	To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.

Locations (6): Atlantic Urology
🇺🇸
Daytona Beach, Florida, United States
Pinellas Urology Inc
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South Pasadena, Florida, United States
Greater Boston Urology
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Hingham, Massachusetts, United States
Brooklyn Urology Research Group
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Brooklyn, New York, United States
Advanced Urology Specialists
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Oxford, Florida, United States
Urology Specialists of West Florida
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Palm Harbor, Florida, United States