Clinical trial NCT02643849: Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men
Official title: Use of The Spanner® Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men Unfit for Other Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Lead sponsor: SRS Medical
Sponsor class: INDUSTRY
First posted: 2015-12-31
Enrollment: 107
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
timeFrame: 90 days
Secondary outcomes:
measure: Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days
timeFrame: 30 days
Other outcomes:
measure: The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days
timeFrame: 30, 60 and 90 days
measure: The Average Maximum Flow Rate Over 90 Days
timeFrame: 1, 30, 60 and 90 days
Locations:
city: Daytona Beach
country: United States
facility: Atlantic Urology
state: Florida
city: Oxford
country: United States
facility: Advanced Urology Specialists
state: Florida
city: Palm Harbor
country: United States
facility: Urology Specialists of West Florida
state: Florida
city: South Pasadena
country: United States
facility: Pinellas Urology Inc
state: Florida
city: Hingham
country: United States
facility: Greater Boston Urology
state: Massachusetts
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
Study officials:
References: