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

Urinary Retention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643849
• Other study ID #: SRS 1.0
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: February 2019

Study information

• Verified date: November 2020
• Source: SRS Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Device:
• The Spanner Temporary Prostatic Stent

Locations

Country	Name	City	State
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Atlantic Urology	Daytona Beach	Florida
United States	Greater Boston Urology	Hingham	Massachusetts
United States	Advanced Urology Specialists	Oxford	Florida
United States	Urology Specialists of West Florida	Palm Harbor	Florida
United States	Pinellas Urology Inc	South Pasadena	Florida

Sponsors (1)

Lead Sponsor	Collaborator
SRS Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days	To determine the distribution of IPSS Scores at each stent replacement visit (Visit 2, 3 and 4). The IPSS Score is calculated from the responses to seven questions related to the severity and frequency of symptoms of benign prostatic hyperplasia (BPH). Each of the seven scored questions are put on a scale of 0-5, with the score of 5 being the worst score and the most severe symptom. The scores for the seven questions are added up and the IPSS score therefore ranges from 0-35, with 0 being the best score and 35 being the worst score. Scores of 0-7 are categorized as "Mild Symptoms". Scores of 8-19 are categorized as "Moderate Symptoms". Scores of 20-35 are categorized as "Severe Symptoms".	30, 60 and 90 days
Other	The Average Maximum Flow Rate Over 90 Days	To determine the average and standard deviation of QMax at each stent visit (Visits 1-4)	1, 30, 60 and 90 days
Primary	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	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