Vesair Clinical Trial (VAPOR)

Solace Therapeutics

Status: Terminated

Conditions: Stress Urinary Incontinence

Treatments: Device: Vesair Balloon; Other: Sham balloon placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04026347

CD1010

Details and patient eligibility

About

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

Enrollment: 158 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

Vesair

Experimental group

Description:

Subjects are treated with Vesair Balloon at enrollment (day 0)

Treatment:

Device: Vesair Balloon

Sham

Sham Comparator group

Description:

Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.

Treatment:

Other: Sham balloon placement

Device: Vesair Balloon