Vesair Clinical Trial

Stress Urinary Incontinence Clinical Trial

— VAPOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04026347
• Other study ID #: CD1010
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: May 2022
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: April 15, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Vesair Balloon
Indwelling, intravesical balloon

Other:
• Sham balloon placement
Sham balloon placement procedure

Locations

Country	Name	City	State
United States	Mercy Health	Ada	Michigan
United States	WomanCare	Arlington Heights	Illinois
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	MetroHealth	Cleveland	Ohio
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	ProHEALTH Garden City Urology	Garden City	New York
United States	Chesapeake Urology	Hanover	Maryland
United States	Houston Metro Urology	Houston	Texas
United States	Washington Urology	Kirkland	Washington
United States	Freedman Urology	Las Vegas	Nevada
United States	CMB Research / Basinski and Juran MDs	Newburgh	Indiana
United States	Chesapeake Urology	Owings Mills	Maryland
United States	Penn Medicine	Philadelphia	Pennsylvania
United States	Valley Urogynecology Associates	Phoenix	Arizona
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Women and Infants dept of Urogynecology	Providence	Rhode Island
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Urology San Antonio	San Antonio	Texas
United States	Scripps Clinic	San Diego	California
United States	Meridian Clinical Research / Urological Associates of Savannah	Savannah	Georgia
United States	Regional Urology	Shreveport	Louisiana
United States	Florida Urology Partners	Tampa	Florida
United States	Tri Valley Urology	Temecula	California
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Dr. Sherry Thomas	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & 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 femal — View Citation

Outcome

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

External Links

•   Company Website
•   Study Website