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



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:45 - Any
Updated:4/6/2019
Start Date:August 2016
End Date:February 2019

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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

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.


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.
We found this trial at
6
sites
35095 U.S. 19
Palm Harbor, Florida 34684
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Brooklyn, New York 11215
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Brooklyn, NY
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545 Health Boulevard
Daytona Beach, Florida 32114
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Daytona Beach, FL
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72 Sharp Street
Hingham, Massachusetts 02043
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Hingham, MA
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12109 County Road 103
Oxford, Florida 34484
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Oxford, FL
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1615 Pasadena Avenue South
South Pasadena, Florida 33707
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South Pasadena, FL
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