Vesair Clinical Trial (VAPOR)

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

Tracking Information

• First Submitted Date: July 17, 2019
• First Posted Date: July 19, 2019
• Last Update Posted Date: July 12, 2021
• Actual Study Start Date: February 1, 2020
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2019)

Composite Endpoint [ Time Frame: 6 months ]

Pad weight + I-QOL

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Vesair Clinical Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Subject and assessor blinded to randomization result

Primary Purpose: Treatment

• Condition: Stress Urinary Incontinence

Intervention

• Device: Vesair Balloon
  Indwelling, intravesical balloon
• Other: Sham balloon placement
  Sham balloon placement procedure

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 9, 2021): 158
• Original Estimated Enrollment (submitted: July 17, 2019): 150
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04026347
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Solace Therapeutics, Inc.
• Study Sponsor: Solace Therapeutics, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Solace Therapeutics, Inc.
• Verification Date: July 2021