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OpenTrials
Completed

NCT Number: NCT02643849

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

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Urology, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Spanner Temporary Prostatic Stent

Device

Primary outcomes

  1. Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days

    Time frame: 90 days

    To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.

Secondary outcomes

  1. Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days

    Time frame: 30 days

    To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.

Other outcomes

  1. The Distribution of International Prostate Symptom Score (IPSS Score) Over 90 Days

    Time frame: 30, 60 and 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".

  2. The Average Maximum Flow Rate Over 90 Days

    Time frame: 1, 30, 60 and 90 days

    To determine the average and standard deviation of QMax at each stent visit (Visits 1-4)

Sponsors and collaborators

Lead sponsor

SRS Medical

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2015
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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