Vesair Clinical Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    150
  • sponsor
    Solace Therapeutics, Inc.
Updated on 7 June 2020
Investigator
Joshua Freeman
Primary Contact
Chesapeake Urology (0.5 mi away) Contact
+15 other location
invasive treatment
incontinence
cystoscopy

Summary

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

Details
Treatment Vesair Balloon, Sham balloon placement
Clinical Study IdentifierNCT04026347
SponsorSolace Therapeutics, Inc.
Last Modified on7 June 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Stress incontinence?
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
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