NCT02643849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

December 22, 2015

Results QC Date

October 21, 2020

Last Update Submit

November 13, 2020

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    30 days

Other Outcomes (2)

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

    30, 60 and 90 days

  • The Average Maximum Flow Rate Over 90 Days

    1, 30, 60 and 90 days

Study Arms (1)

Spanner

EXPERIMENTAL
Device: The Spanner Temporary Prostatic Stent

Interventions

The Spanner Temporary Prostatic StentDEVICE
Spanner

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Atlantic Urology

Daytona Beach, Florida, 32114, United States

Location

Advanced Urology Specialists

Oxford, Florida, 34484, United States

Location

Urology Specialists of West Florida

Palm Harbor, Florida, 34684, United States

Location

Pinellas Urology Inc

South Pasadena, Florida, 33707, United States

Location

Greater Boston Urology

Hingham, Massachusetts, 02043, United States

Location

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
SRS Medical
info@srsmedical.com
800-345-5642

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 31, 2015

Study Start

August 1, 2016

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

November 19, 2020

Results First Posted

November 19, 2020

Record last verified: 2020-11

Locations

US(6)