Status:
TERMINATED
Vesair Clinical Trial
Lead Sponsor:
Solace Therapeutics, Inc.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04026347
Start Date
February 1 2020
End Date
April 15 2022
Last Update
May 13 2022
Active Locations (25)
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1
Valley Urogynecology Associates
Phoenix, Arizona, United States, 85016
2
Scripps Clinic
San Diego, California, United States, 92130
3
Tri Valley Urology
Temecula, California, United States, 92592
4
Dr. Sherry Thomas
Westlake Village, California, United States, 91361