Vesair Balloon Confirmatory Trial (VECTOR) (VECTOR)

June 10, 2022 updated by: Solace Therapeutics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • WomanCare
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Women and Infants dept of Urogynecology
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia
    • Washington
      • Kirkland, Washington, United States, 98034
        • Washington Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provocative Pad Weight
Time Frame: 3 months
in-office Pad weight test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solace Therapeutics, Inc.

Investigators

  • Principal Investigator: Charles Rardin, M.D., Women and Infants Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD1009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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