Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve B… (NCT02643849) | Clinical Trial Compass
CompletedNot Applicable
Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men
United States107 participantsStarted 2016-08
Plain-language 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.
Who can participate
Age range
45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days