Study Stopped
Missed endpoint
Vesair Clinical Trial
VAPOR
An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
1 other identifier
interventional
158
1 country
25
Brief Summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Typical duration for not_applicable
25 active sites
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
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedMay 13, 2022
May 1, 2022
2.1 years
July 17, 2019
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Endpoint
Pad weight + I-QOL
6 months
Secondary Outcomes (4)
Pad Weight
6 months
I-QOL
6 months
Episode Frequency
6 months
Patient Global Impression of Improvement (PGI-I)
6 months
Study Arms (2)
Vesair
EXPERIMENTALSubjects are treated with Vesair Balloon at enrollment (day 0)
Sham
SHAM COMPARATORSubjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Valley Urogynecology Associates
Phoenix, Arizona, 85016, United States
Scripps Clinic
San Diego, California, 92130, United States
Tri Valley Urology
Temecula, California, 92592, United States
Dr. Sherry Thomas
Westlake Village, California, 91361, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Florida Urology Partners
Tampa, Florida, 33615, United States
Meridian Clinical Research / Urological Associates of Savannah
Savannah, Georgia, 31405, United States
WomanCare
Arlington Heights, Illinois, 60004, United States
CMB Research / Basinski and Juran MDs
Newburgh, Indiana, 47630, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Chesapeake Urology
Hanover, Maryland, 21076, United States
Chesapeake Urology
Owings Mills, Maryland, 21117, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02210, United States
Mercy Health
Ada, Michigan, 49301, United States
Freedman Urology
Las Vegas, Nevada, 89144, United States
ProHEALTH Garden City Urology
Garden City, New York, 11530, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
MetroHealth
Cleveland, Ohio, 44109, United States
Penn Medicine
Philadelphia, Pennsylvania, 19041, United States
Women and Infants dept of Urogynecology
Providence, Rhode Island, 02903, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Washington Urology
Kirkland, Washington, 98034, United States
Related Publications (1)
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.
PMID: 29095516RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subject and assessor blinded to randomization result
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 19, 2019
Study Start
February 1, 2020
Primary Completion
February 28, 2022
Study Completion
April 15, 2022
Last Updated
May 13, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share