Vesair Clinical Trial
- Conditions
- Stress Urinary Incontinence
- Interventions
- Device: Vesair BalloonOther: Sham balloon placement
- Registration Number
- NCT04026347
- Lead Sponsor
- Solace Therapeutics, Inc.
- Brief Summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 158
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vesair Vesair Balloon Subjects are treated with Vesair Balloon at enrollment (day 0) Sham Vesair Balloon Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit. Sham Sham balloon placement Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
- Primary Outcome Measures
Name Time Method Composite Endpoint 6 months Pad weight + I-QOL
- Secondary Outcome Measures
Name Time Method Episode Frequency 6 months Reduction in episode frequency as reported on a 7 day diary
Pad Weight 6 months Reduction in pad weight
I-QOL 6 months Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
Patient Global Impression of Improvement (PGI-I) 6 months Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)
Trial Locations
- Locations (24)
Valley Urogynecology Associates
🇺🇸Phoenix, Arizona, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
MetroHealth
🇺🇸Cleveland, Ohio, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
ProHEALTH Garden City Urology
🇺🇸Garden City, New York, United States
Meridian Clinical Research / Urological Associates of Savannah
🇺🇸Savannah, Georgia, United States
WomanCare
🇺🇸Arlington Heights, Illinois, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Scripps Clinic
🇺🇸San Diego, California, United States
Washington Urology
🇺🇸Kirkland, Washington, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Freedman Urology
🇺🇸Las Vegas, Nevada, United States
Women's Health Specialty Care
🇺🇸Farmington, Connecticut, United States
Tri Valley Urology
🇺🇸Temecula, California, United States
Dr. Sherry Thomas
🇺🇸Westlake Village, California, United States
CMB Research / Basinski and Juran MDs
🇺🇸Newburgh, Indiana, United States
Chesapeake Urology
🇺🇸Owings Mills, Maryland, United States
Mercy Health
🇺🇸Ada, Michigan, United States
Women and Infants dept of Urogynecology
🇺🇸Providence, Rhode Island, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States