Vesair Clinical Trial

Stopped early · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

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

Key facts

Study ID

NCT04026347

Run by

Solace Therapeutics, Inc.

People needed

158

Starts

2020-02-01

Expected to finish

2022-04-15

Last updated by the study team

2022-05-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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