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

NCT ID: NCT02643849

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Retention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spanner

Group Type EXPERIMENTAL

The Spanner Temporary Prostatic Stent

Intervention Type DEVICE

Interventions

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The Spanner Temporary Prostatic Stent

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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SRS Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantic Urology

Daytona Beach, Florida, United States

Site Status

Advanced Urology Specialists

Oxford, Florida, United States

Site Status

Urology Specialists of West Florida

Palm Harbor, Florida, United States

Site Status

Pinellas Urology Inc

South Pasadena, Florida, United States

Site Status

Greater Boston Urology

Hingham, Massachusetts, United States

Site Status

Brooklyn Urology Research Group

Brooklyn, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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SRS 1.0

Identifier Type: -

Identifier Source: org_study_id