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Vesair Balloon Confirmatory Trial (VECTOR) (VECTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794206
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

Study Description
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Brief Summary:
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Vesair Balloon Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : August 26, 2019
Estimated Study Completion Date : June 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Single-arm of subjects who receive treatment with Vesair Balloon
 Device: Vesair Balloon
Treatment with Vesair Balloon for one year


Outcome Measures
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Primary Outcome Measures :
  1. Provocative Pad Weight [ Time Frame: 3 months ]
    in-office Pad weight test


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated with Vesair Balloon within the past 4 years
  • Normal voiding function
  • Has signed consent
  • Willing to undergo cystoscopy
  • Available for minimum of 12 months

Exclusion Criteria:

  • Last Menstrual Period within past 4 years
  • Systemic birth control medication (including implants) or systemic hormone replacement therapy (estrogen or progesterone) in the past 4 years.
  • History of urosepsis, bladder infection, urinary tract infection or asymptomatic bacteriuria within the past 3 months.
  • Urinary incontinence of neurogenic etiology.
  • Prior pelvic surgery that may affect incontinence symptoms (including placement and/or removal of a suburethral sling) within the past 4 years.
  • Noninvasive treatment for incontinence, such as nerve stimulation, Botox injections, biofeedback, formal pelvic floor muscle training, and/or vaginal laser therapy, within the past 3 months.
  • Taken medications other than anticholinergics that may affect SUI symptoms (such as enobosarm, duloxetine or imipramine) in the past 3 months.
  • Taking other pharmacologic agents that may have a significant effect on bladder function unless on the therapy for at least 3 months and intending to continue the same dosage of the medication throughout the trial.
  • History of recurrent (>1) kidney stones, or one kidney stone within the past 5 years.
  • History of an artificial urinary sphincter.
  • Presence of gross hematuria and/or blood clots in the urine.
  • History of interstitial or follicular cystitis or other painful bladder syndrome.
  • Cystocele verified as Stage 3 or higher by PoP-Q Classification.
  • Local genital skin infection.
  • Urethral or bladder inflammation and/or edema, or other hypersensitivity to cystoscopy or other urethral manipulations.
  • Evidence of involuntary detrusor contractions and/or discomfort during bladder filling up to 300cc.
  • Undergoing or anticipating a course of pelvic radiation therapy or with severe pelvic fibrosis from previous radiation therapy.
  • Non-ambulatory, bedridden or physically unable to complete test exercises.
  • History of recent alcoholism or illicit drug abuse within the last year.
  • Immunologically suppressed or immunocompromised.
  • History of any neurological disease that could impact bladder function including Parkinson's disease, multiple sclerosis or post-stroke sequelae.
  • Uncontrolled diabetes (persistent A1C levels >9 percent).
  • History of any malignancy (except non-melanoma skin cancer), unless the cancer was not in the urinary tract, the cancer was stage II or less, the cancer was treated with curative intent, AND there have been no clinical signs or symptoms of the malignancy for at least 2 years.
  • Morbid obesity, defined as BMI ≥40.0.
  • History of any autoimmune or connective tissue disease or disorder that could impact bladder function
Contacts and Locations
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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): NCT03794206


Locations
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United States, Illinois
WomanCare
Arlington Heights, Illinois, United States, 60004
United States, Louisiana
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, Maryland
Chesapeake Urology
Hanover, Maryland, United States, 21076
Chesapeake Urology
Owings Mills, Maryland, United States, 21117
United States, New York
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
United States, Rhode Island
Women and Infants dept of Urogynecology
Providence, Rhode Island, United States, 02903
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
United States, Washington
Washington Urology
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Solace Therapeutics, Inc.
Investigators
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Principal Investigator: Charles Rardin, M.D. Women and Infants Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03794206    
Other Study ID Numbers: CD1009
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: September 23, 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
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders