Clinical trial NCT04026347: Vesair Clinical Trial
Official title: An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: SUI
Women
Incontinence
Lead sponsor: Solace Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Composite Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Pad Weight
timeFrame: 6 months
measure: I-QOL
timeFrame: 6 months
measure: Episode Frequency
timeFrame: 6 months
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Urogynecology Associates
state: Arizona
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: Temecula
country: United States
facility: Tri Valley Urology
state: California
city: Westlake Village
country: United States
facility: Dr. Sherry Thomas
state: California
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research / Urological Associates of Savannah
state: Georgia
city: Arlington Heights
country: United States
facility: WomanCare
state: Illinois
city: Newburgh
country: United States
facility: CMB Research / Basinski and Juran MDs
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Ada
country: United States
facility: Mercy Health
state: Michigan
city: Las Vegas
country: United States
facility: Freedman Urology
state: Nevada
city: Garden City
country: United States
facility: ProHEALTH Garden City Urology
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants dept of Urogynecology
state: Rhode Island
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Kirkland
country: United States
facility: Washington Urology
state: Washington
Study officials:
References:
citation: 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.