Study Stopped
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Vesair Balloon Confirmatory Trial (VECTOR)
VECTOR
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
1 other identifier
interventional
20
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 4, 2019
CompletedStudy Start
First participant enrolled
February 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2022
CompletedJune 13, 2022
June 1, 2022
7 months
January 3, 2019
June 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Provocative Pad Weight
in-office Pad weight test
3 months
Study Arms (1)
Treatment Arm
EXPERIMENTALSingle-arm of subjects who receive treatment with Vesair Balloon
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
WomanCare
Arlington Heights, Illinois, 60004, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Chesapeake Urology
Hanover, Maryland, 21076, United States
Chesapeake Urology
Owings Mills, Maryland, 21117, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Women and Infants dept of Urogynecology
Providence, Rhode Island, 02903, United States
Urology of Virginia
Virginia Beach, Virginia, 23462, United States
Washington Urology
Kirkland, Washington, 98034, United States
Related Publications (1)
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.
PMID: 29095516BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Rardin, M.D.
Women and Infants Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 4, 2019
Study Start
February 11, 2019
Primary Completion
August 26, 2019
Study Completion
April 28, 2022
Last Updated
June 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share