Vesair Clinical Trial (VAPOR)

May 9, 2022 updated by: Solace Therapeutics, Inc.

An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Valley Urogynecology Associates
    • California
      • San Diego, California, United States, 92130
        • Scripps Clinic
      • Temecula, California, United States, 92592
        • Tri Valley Urology
      • Westlake Village, California, United States, 91361
        • Dr. Sherry Thomas
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Women's Health Specialty Care
    • Florida
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Meridian Clinical Research / Urological Associates of Savannah
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • WomanCare
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • CMB Research / Basinski and Juran MDs
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
        • Beth Israel Deaconess Medical Center (BIDMC)
    • Michigan
      • Ada, Michigan, United States, 49301
        • Mercy Health
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Freedman Urology
    • New York
      • Garden City, New York, United States, 11530
        • ProHEALTH Garden City Urology
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19041
        • Penn Medicine
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Women and Infants dept of Urogynecology
    • Texas
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Kirkland, Washington, United States, 98034
        • Washington Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vesair
Subjects are treated with Vesair Balloon at enrollment (day 0)
Device: Vesair Balloon
Indwelling, intravesical balloon
SHAM_COMPARATOR: Sham
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
Device: Vesair Balloon
Indwelling, intravesical balloon
Other: Sham balloon placement
Sham balloon placement procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint
Time Frame: 6 months
Pad weight + I-QOL
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pad Weight
Time Frame: 6 months
Reduction in pad weight
6 months
I-QOL
Time Frame: 6 months
Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
6 months
Episode Frequency
Time Frame: 6 months
Reduction in episode frequency as reported on a 7 day diary
6 months
Patient Global Impression of Improvement (PGI-I)
Time Frame: 6 months
Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solace Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

April 15, 2022

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (ACTUAL)

July 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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