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出境医 / 临床实验 / Vesair Clinical Trial (VAPOR)

Vesair Clinical Trial (VAPOR)

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

Study Design
Layout table for study information
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 : January 31, 2022
Estimated Study Completion Date : December 31, 2024
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 :
  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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 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
Contacts and Locations

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

Locations
Show Show 25 study locations
Sponsors and Collaborators
Solace Therapeutics, Inc.
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date April 29, 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
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: Joshua A Freeman 508-283-1200 ext 168 jfreeman@solacetx.com
Contact: Nicole Shugrue 508-283-1200 ext 165 nschugrue@solacetx.com
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 April 2021

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

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