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

Study Overview
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Brief Summary
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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.

Official Title
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Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: The Spanner Temporary Prostatic Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spanner<br> | Device: The Spanner Temporary Prostatic Stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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