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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Device: The Spanner Temporary Prostatic Stent

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Atlantic Urology
    • Oxford, Florida, United States, 34484
      • Advanced Urology Specialists
    • Palm Harbor, Florida, United States, 34684
      • Urology Specialists of West Florida
    • South Pasadena, Florida, United States, 33707
      • Pinellas Urology Inc
  • Massachusetts
    • Hingham, Massachusetts, United States, 02043
      • Greater Boston Urology
  • New York
    • Brooklyn, New York, United States, 11215
      • Brooklyn Urology Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spanner	Device: The Spanner Temporary Prostatic Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: SRS Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: SRS 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided