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

SRS Medical6 sites in 1 country107 target enrollmentAugust 2016

ConditionsUrinary Retention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Retention
Sponsor: SRS Medical
Enrollment: 107
Locations: 6
Primary Endpoint: Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

February 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

SRS Medical

Responsible Party

Sponsor

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);