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Vesair Clinical Trial (VAPOR)

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ClinicalTrials.gov Identifier: NCT04026347
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

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
Stress Urinary Incontinence Device: Vesair Balloon Other: Sham balloon placement Not Applicable

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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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Composite Endpoint [ Time Frame: 6 months ]
    Pad weight + I-QOL


Secondary Outcome Measures :
  1. Pad Weight [ Time Frame: 6 months ]
    Reduction in pad weight

  2. I-QOL [ Time Frame: 6 months ]
    Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)

  3. Episode Frequency [ Time Frame: 6 months ]
    Reduction in episode frequency as reported on a 7 day diary

  4. 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:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Joshua A Freeman 508-283-1200 ext 168 jfreeman@solacetx.com
Contact: Nicole Shugrue 508-283-1200 ext 165 nschugrue@solacetx.com

Sponsors and Collaborators
Solace Therapeutics, Inc.

Additional Information:
Publications of Results:
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Responsible Party: Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04026347     History of Changes
Other Study ID Numbers: CD1010
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Solace Therapeutics, Inc.:
SUI
Women
Incontinence

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders