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

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Spanner Temporary Prostatic Stent
Sponsored by
SRS Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlantic Urology
  • Advanced Urology Specialists
  • Urology Specialists of West Florida
  • Pinellas Urology Inc
  • Greater Boston Urology
  • Brooklyn Urology Research Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spanner

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 22, 2015
Last Updated
November 13, 2020
Sponsor
SRS Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02643849
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SRS Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spanner
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The Spanner Temporary Prostatic Stent
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
Description
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days
Description
To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days
Description
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".
Time Frame
30, 60 and 90 days
Title
The Average Maximum Flow Rate Over 90 Days
Description
To determine the average and standard deviation of QMax at each stent visit (Visits 1-4)
Time Frame
1, 30, 60 and 90 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Atlantic Urology
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Advanced Urology Specialists
City
Oxford
State/Province
Florida
ZIP/Postal Code
34484
Country
United States
Facility Name
Urology Specialists of West Florida
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pinellas Urology Inc
City
South Pasadena
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Greater Boston Urology
City
Hingham
State/Province
Massachusetts
ZIP/Postal Code
02043
Country
United States
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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