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Vesair Clinical Trial (VAPOR)

Primary Purpose

Stress Urinary Incontinence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vesair Balloon
Sham balloon placement
Sponsored by
Solace Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring SUI, Women, Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-menopausal women with SUI for at least 12 months
  • Average of at least one leak per day
  • Failed non-invasive treatment
  • Willing to undergo cystoscopy and a minimum of 5 visits over one year

Exclusion Criteria:

  • BMI > 40.0
  • Last menstrual period within 12 months of enrollment
  • On birth control and/or oral hormone replacement therapy
  • Urge-predominant mixed incontinence
  • SUI due to intrinsic sphincter deficiency
  • Prior treatment with the Vesair Balloon
  • Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
  • Recurrent or recent (within the past 5 years) kidney stones
  • Recurrent or recent (within the past 3 months) Urinary Tract Infection
  • Stage 3 or higher cystocele (POP-Q)
  • Interstitial or follicular cystitis / painful bladder syndrome
  • Local genital infection
  • Artificial sphincter
  • Anatomic abnormalities which would interfere with device placement.
  • Visible blood in the urine
  • Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
  • History of cancer of the urinary tract
  • History of any cancer within the past two years (excluding non-melanoma skin cancers)
  • History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
  • Immunologically suppressed or immunocompromised
  • Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
  • Non ambulatory / unable to do simple pad weight testing exercises
  • On anticoagulation therapy with the exception of aspirin
  • History of mental illness requiring inpatient treatment
  • Neurological disease such as Parkinson's or multiple sclerosis
  • Uncontrolled diabetes (A1C > 9%)
  • Recent alcohol or drug abuse requiring treatment in the past year
  • Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
  • Allergy to polyurethane or perfluorocarbons

Sites / Locations

  • Valley Urogynecology Associates
  • Scripps Clinic
  • Tri Valley Urology
  • Dr. Sherry Thomas
  • Women's Health Specialty Care
  • Florida Urology Partners
  • Meridian Clinical Research / Urological Associates of Savannah
  • WomanCare
  • CMB Research / Basinski and Juran MDs
  • Regional Urology
  • Chesapeake Urology
  • Chesapeake Urology
  • Beth Israel Deaconess Medical Center (BIDMC)
  • Mercy Health
  • Freedman Urology
  • ProHEALTH Garden City Urology
  • Premier Medical Group of the Hudson Valley
  • Associated Urologists of North Carolina
  • MetroHealth
  • Penn Medicine
  • Women and Infants dept of Urogynecology
  • Houston Metro Urology
  • Urology San Antonio
  • Urology of Virginia
  • Washington Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vesair

Sham

Arm Description

Subjects are treated with Vesair Balloon at enrollment (day 0)

Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.

Outcomes

Primary Outcome Measures

Composite Endpoint
Pad weight + I-QOL

Secondary Outcome Measures

Pad Weight
Reduction in pad weight
I-QOL
Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
Episode Frequency
Reduction in episode frequency as reported on a 7 day diary
Patient Global Impression of Improvement (PGI-I)
Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)

Full Information

First Posted
July 17, 2019
Last Updated
May 9, 2022
Sponsor
Solace Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04026347
Brief Title
Vesair Clinical Trial
Acronym
VAPOR
Official Title
An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Missed endpoint
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solace Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
SUI, Women, Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Subject and assessor blinded to randomization result
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vesair
Arm Type
Experimental
Arm Description
Subjects are treated with Vesair Balloon at enrollment (day 0)
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
Intervention Type
Device
Intervention Name(s)
Vesair Balloon
Intervention Description
Indwelling, intravesical balloon
Intervention Type
Other
Intervention Name(s)
Sham balloon placement
Intervention Description
Sham balloon placement procedure
Primary Outcome Measure Information:
Title
Composite Endpoint
Description
Pad weight + I-QOL
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pad Weight
Description
Reduction in pad weight
Time Frame
6 months
Title
I-QOL
Description
Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
Time Frame
6 months
Title
Episode Frequency
Description
Reduction in episode frequency as reported on a 7 day diary
Time Frame
6 months
Title
Patient Global Impression of Improvement (PGI-I)
Description
Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-menopausal women with SUI for at least 12 months Average of at least one leak per day Failed non-invasive treatment Willing to undergo cystoscopy and a minimum of 5 visits over one year Exclusion Criteria: BMI > 40.0 Last menstrual period within 12 months of enrollment On birth control and/or oral hormone replacement therapy Urge-predominant mixed incontinence SUI due to intrinsic sphincter deficiency Prior treatment with the Vesair Balloon Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment Recurrent or recent (within the past 5 years) kidney stones Recurrent or recent (within the past 3 months) Urinary Tract Infection Stage 3 or higher cystocele (POP-Q) Interstitial or follicular cystitis / painful bladder syndrome Local genital infection Artificial sphincter Anatomic abnormalities which would interfere with device placement. Visible blood in the urine Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc History of cancer of the urinary tract History of any cancer within the past two years (excluding non-melanoma skin cancers) History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers) Immunologically suppressed or immunocompromised Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation Non ambulatory / unable to do simple pad weight testing exercises On anticoagulation therapy with the exception of aspirin History of mental illness requiring inpatient treatment Neurological disease such as Parkinson's or multiple sclerosis Uncontrolled diabetes (A1C > 9%) Recent alcohol or drug abuse requiring treatment in the past year Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis Allergy to polyurethane or perfluorocarbons
Facility Information:
Facility Name
Valley Urogynecology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Tri Valley Urology
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Dr. Sherry Thomas
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Meridian Clinical Research / Urological Associates of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
WomanCare
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
CMB Research / Basinski and Juran MDs
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Chesapeake Urology
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Mercy Health
City
Ada
State/Province
Michigan
ZIP/Postal Code
49301
Country
United States
Facility Name
Freedman Urology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
ProHEALTH Garden City Urology
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
MetroHealth
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19041
Country
United States
Facility Name
Women and Infants dept of Urogynecology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Washington Urology
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29095516
Citation
McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.
Results Reference
result
Links:
URL
http://www.solacetx.com
Description
Company Website

Learn more about this trial

Vesair Clinical Trial

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