Vesair Clinical Trial (VAPOR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04026347 |
Recruitment Status :
Recruiting
First Posted : July 19, 2019
Last Update Posted : June 1, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stress Urinary Incontinence | Device: Vesair Balloon Other: Sham balloon placement | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Subject and assessor blinded to randomization result |
Primary Purpose: | Treatment |
Official Title: | An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women |
Actual Study Start Date : | February 1, 2020 |
Estimated Primary Completion Date : | March 31, 2021 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Vesair
Subjects are treated with Vesair Balloon at enrollment (day 0)
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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.
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Device: Vesair Balloon
Indwelling, intravesical balloon Other: Sham balloon placement Sham balloon placement procedure |
- Composite Endpoint [ Time Frame: 6 months ]Pad weight + I-QOL
- Pad Weight [ Time Frame: 6 months ]Reduction in pad weight
- I-QOL [ Time Frame: 6 months ]Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
- Episode Frequency [ Time Frame: 6 months ]Reduction in episode frequency as reported on a 7 day diary
- Patient Global Impression of Improvement (PGI-I) [ Time Frame: 6 months ]Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026347
Contact: Joshua A Freeman | 508-283-1200 ext 168 | jfreeman@solacetx.com | |
Contact: Nicole Shugrue | 508-283-1200 ext 165 | nschugrue@solacetx.com |
United States, Arizona | |
Valley Urogynecology Associates | Recruiting |
Phoenix, Arizona, United States, 85016 | |
Contact: Anna Downer 602-788-1521 adowner@valleyurogyn.com | |
Principal Investigator: Shazia Malik, MD | |
Sub-Investigator: Felipe Videla, MD | |
Sub-Investigator: Paul Marshburn, MD | |
Sub-Investigator: Daniel Stone, M.D. | |
United States, California | |
Scripps Clinic | Suspended |
San Diego, California, United States, 92130 | |
Tri Valley Urology | Recruiting |
Temecula, California, United States, 92592 | |
Contact: Anita Deeds 951-698-1901 ext 232 anita@trivalleyurology.com | |
Principal Investigator: Benjamin T. Larson, M.D. | |
United States, Connecticut | |
Women's Health Specialty Care | Recruiting |
Farmington, Connecticut, United States, 06032 | |
Contact: Madeline Vazquez 860-678-7300 ext 5 mvazquez@womenshealthct.com | |
Principal Investigator: Jill Peters-Gee, M.D. | |
Sub-Investigator: Adine Regan, M.D. | |
United States, Florida | |
Florida Urology Partners | Recruiting |
Tampa, Florida, United States, 33615 | |
Contact: Linda Seibert, M.S. 239-223-4488 linda@gulfcoastcta.com | |
Principal Investigator: Osvaldo Padron, M.D. | |
United States, Illinois | |
WomanCare | Recruiting |
Arlington Heights, Illinois, United States, 60004 | |
Contact: Valerie Umbright 847-221-4241 vumbrigh@womancarepc.com | |
Principal Investigator: Randall Kahan, M.D. | |
United States, Louisiana | |
Regional Urology | Recruiting |
Shreveport, Louisiana, United States, 71106 | |
Contact: Leah Renfro 318-683-0411 ext 125 lrenfro@regionalresearchspecialists.com | |
Principal Investigator: Kevin Cline, M.D. | |
Sub-Investigator: Allison Spann, M.D. | |
Sub-Investigator: Ashley Baker, M.D. | |
United States, Maryland | |
Chesapeake Urology | Recruiting |
Hanover, Maryland, United States, 21076 | |
Contact: Wendy Paxton 443-471-5763 wpaxton@chesuro.com | |
Principal Investigator: Kaiser Robertson, M.D. | |
Chesapeake Urology | Suspended |
Owings Mills, Maryland, United States, 21117 | |
United States, Michigan | |
Mercy Health | Not yet recruiting |
Ada, Michigan, United States, 49301 | |
Contact: Julie Bishop, RN 616-685-4691 Julie.A.Bishop@mercyhealth.com | |
Principal Investigator: Jason Bennett, M.D. | |
United States, Nevada | |
Freedman Urology | Recruiting |
Las Vegas, Nevada, United States, 89144 | |
Contact: Jose Medina 702-675-3102 josemedina@freedmanurology.com | |
Principal Investigator: Sheldon Freedman, M.D. | |
United States, New York | |
Premier Medical Group of the Hudson Valley | Recruiting |
Poughkeepsie, New York, United States, 12601 | |
Contact: Lisa Gray 845-437-3804 lgray@premiermedicalhv.com | |
Principal Investigator: Daniel Katz, M.D. | |
United States, North Carolina | |
Associated Urologists of North Carolina | Recruiting |
Raleigh, North Carolina, United States, 27612 | |
Contact: Charlene Flahiff, MS 919-390-7352 cflahiff@auncurology.com | |
Contact: Glenna Gourley 919.390.7354 ggourley@auncurology.com | |
Principal Investigator: Mark Jalkut, M.D. | |
United States, Pennsylvania | |
Penn Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19041 | |
Contact: Zandra Kennedy 215-615-6569 zandra.kennedy@pennmedicine.upenn.edu | |
Principal Investigator: Lily Arya, M.D. | |
Sub-Investigator: Uduak Andy, M.D. | |
Sub-Investigator: Heidi Harvie, M.D. | |
United States, Rhode Island | |
Women and Infants dept of Urogynecology | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Sara Veera, B.S. 401-274-1122 ext 48222 sveera@wihri.org | |
Principal Investigator: Charles Rardin, M.D. | |
United States, Virginia | |
Urology of Virginia | Recruiting |
Virginia Beach, Virginia, United States, 23462 | |
Contact: Leigh Ann Brand 757-452-3421 lbrand@urologyofva.net | |
Principal Investigator: Kurt McCammon, M.D. | |
Sub-Investigator: Jennifer Miles-Thomas, M.D. | |
Sub-Investigator: Jessica DeLong, M.D. | |
United States, Washington | |
Washington Urology | Recruiting |
Kirkland, Washington, United States, 98034 | |
Contact: Kayla Lee, LPN 425-398-9355 KLee@WaUrology.com | |
Principal Investigator: Karny Jacoby, M.D. |
Publications of Results:
Responsible Party: | Solace Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04026347 |
Other Study ID Numbers: |
CD1010 |
First Posted: | July 19, 2019 Key Record Dates |
Last Update Posted: | June 1, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
SUI Women Incontinence |
Urinary Incontinence Enuresis Urinary Incontinence, Stress Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |