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Vesair Clinical Trial (VAPOR)

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ClinicalTrials.gov Identifier: NCT04026347
Recruitment Status : Active, not recruiting
First Posted : July 19, 2019
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 12, 2021
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
Composite Endpoint [ Time Frame: 6 months ]
Pad weight + I-QOL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Pad Weight [ Time Frame: 6 months ]
    Reduction in pad weight
  • I-QOL [ Time Frame: 6 months ]
    Improvement in I-QOL score
  • Episode Frequency [ Time Frame: 6 months ]
    Reduction in episode frequency
  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: 6 months ]
    Significant Improvement per PGI-I
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vesair Clinical Trial
Official Title  ICMJE An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Brief Summary Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Subject and assessor blinded to randomization result
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • Device: Vesair Balloon
    Indwelling, intravesical balloon
  • Other: Sham balloon placement
    Sham balloon placement procedure
Study Arms  ICMJE
  • Experimental: Vesair
    Subjects are treated with Vesair Balloon at enrollment (day 0)
    Intervention: Device: Vesair Balloon
  • Sham Comparator: Sham
    Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
    Interventions:
    • Device: Vesair Balloon
    • Other: Sham balloon placement
Publications * McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 9, 2021)
158
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
150
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026347
Other Study ID Numbers  ICMJE CD1010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Solace Therapeutics, Inc.
Study Sponsor  ICMJE Solace Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Solace Therapeutics, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP