VAPOR: Vesair Clinical Trial
Study Details
Study Description
Brief Summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Vesair Subjects are treated with Vesair Balloon at enrollment (day 0) |
Device: Vesair Balloon
Indwelling, intravesical balloon
|
Sham Comparator: Sham Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit. |
Device: Vesair Balloon
Indwelling, intravesical balloon
Other: Sham balloon placement
Sham balloon placement procedure
|
Outcome Measures
Primary Outcome Measures
- Composite Endpoint [6 months]
Pad weight + I-QOL
Secondary Outcome Measures
- 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)
- Episode Frequency [6 months]
Reduction in episode frequency as reported on a 7 day diary
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Post-menopausal women with SUI for at least 12 months
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Average of at least one leak per day
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Failed non-invasive treatment
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Willing to undergo cystoscopy and a minimum of 5 visits over one year
Exclusion Criteria:
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BMI > 40.0
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Last menstrual period within 12 months of enrollment
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On birth control and/or oral hormone replacement therapy
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Urge-predominant mixed incontinence
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SUI due to intrinsic sphincter deficiency
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Prior treatment with the Vesair Balloon
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Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
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Recurrent or recent (within the past 5 years) kidney stones
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Recurrent or recent (within the past 3 months) Urinary Tract Infection
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Stage 3 or higher cystocele (POP-Q)
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Interstitial or follicular cystitis / painful bladder syndrome
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Local genital infection
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Artificial sphincter
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Anatomic abnormalities which would interfere with device placement.
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Visible blood in the urine
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Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
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History of cancer of the urinary tract
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History of any cancer within the past two years (excluding non-melanoma skin cancers)
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History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
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Immunologically suppressed or immunocompromised
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Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
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Non ambulatory / unable to do simple pad weight testing exercises
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On anticoagulation therapy with the exception of aspirin
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History of mental illness requiring inpatient treatment
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Neurological disease such as Parkinson's or multiple sclerosis
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Uncontrolled diabetes (A1C > 9%)
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Recent alcohol or drug abuse requiring treatment in the past year
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Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
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Allergy to polyurethane or perfluorocarbons
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 |
5 | Women's Health Specialty Care | Farmington | Connecticut | United States | 06032 |
6 | Florida Urology Partners | Tampa | Florida | United States | 33615 |
7 | Meridian Clinical Research / Urological Associates of Savannah | Savannah | Georgia | United States | 31405 |
8 | WomanCare | Arlington Heights | Illinois | United States | 60004 |
9 | CMB Research / Basinski and Juran MDs | Newburgh | Indiana | United States | 47630 |
10 | Regional Urology | Shreveport | Louisiana | United States | 71106 |
11 | Chesapeake Urology | Hanover | Maryland | United States | 21076 |
12 | Chesapeake Urology | Owings Mills | Maryland | United States | 21117 |
13 | Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | United States | 02210 |
14 | Mercy Health | Ada | Michigan | United States | 49301 |
15 | Freedman Urology | Las Vegas | Nevada | United States | 89144 |
16 | ProHEALTH Garden City Urology | Garden City | New York | United States | 11530 |
17 | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | United States | 12601 |
18 | Associated Urologists of North Carolina | Raleigh | North Carolina | United States | 27612 |
19 | MetroHealth | Cleveland | Ohio | United States | 44109 |
20 | Penn Medicine | Philadelphia | Pennsylvania | United States | 19041 |
21 | Women and Infants dept of Urogynecology | Providence | Rhode Island | United States | 02903 |
22 | Houston Metro Urology | Houston | Texas | United States | 77027 |
23 | Urology San Antonio | San Antonio | Texas | United States | 78229 |
24 | Urology of Virginia | Virginia Beach | Virginia | United States | 23462 |
25 | Washington Urology | Kirkland | Washington | United States | 98034 |
Sponsors and Collaborators
- Solace Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CD1010