VAPOR: Vesair Clinical Trial

Sponsor
Solace Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04026347
Collaborator
(none)
158
25
2
26.4
6.3
0.2

Study Details

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
  • Device: Vesair Balloon
  • Other: Sham balloon placement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
158 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 VesairĀ® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Apr 15, 2022

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 [6 months]

    Pad weight + I-QOL

Secondary Outcome Measures

  1. Pad Weight [6 months]

    Reduction in pad weight

  2. I-QOL [6 months]

    Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)

  3. Episode Frequency [6 months]

    Reduction in episode frequency as reported on a 7 day diary

  4. Patient Global Impression of Improvement (PGI-I) [6 months]

    Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Valley Urogynecology Associates Phoenix Arizona United States 85016
2 Scripps Clinic San Diego California United States 92130
3 Tri Valley Urology Temecula California United States 92592
4 Dr. Sherry Thomas Westlake Village California United States 91361
5 Women's Health Specialty Care Farmington Connecticut United States 06032
6 Florida Urology Partners Tampa Florida United States 33615
7 Meridian Clinical Research / Urological Associates of Savannah Savannah Georgia United States 31405
8 WomanCare Arlington Heights Illinois United States 60004
9 CMB Research / Basinski and Juran MDs Newburgh Indiana United States 47630
10 Regional Urology Shreveport Louisiana United States 71106
11 Chesapeake Urology Hanover Maryland United States 21076
12 Chesapeake Urology Owings Mills Maryland United States 21117
13 Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts United States 02210
14 Mercy Health Ada Michigan United States 49301
15 Freedman Urology Las Vegas Nevada United States 89144
16 ProHEALTH Garden City Urology Garden City New York United States 11530
17 Premier Medical Group of the Hudson Valley Poughkeepsie New York United States 12601
18 Associated Urologists of North Carolina Raleigh North Carolina United States 27612
19 MetroHealth Cleveland Ohio United States 44109
20 Penn Medicine Philadelphia Pennsylvania United States 19041
21 Women and Infants dept of Urogynecology Providence Rhode Island United States 02903
22 Houston Metro Urology Houston Texas United States 77027
23 Urology San Antonio San Antonio Texas United States 78229
24 Urology of Virginia Virginia Beach Virginia United States 23462
25 Washington Urology Kirkland Washington United States 98034

Sponsors and Collaborators

  • Solace Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04026347
Other Study ID Numbers:
  • CD1010
First Posted:
Jul 19, 2019
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Solace Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022