Vesair Balloon Confirmatory Trial (VECTOR)

Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Age Range:Any
Start Date:February 11, 2019
End Date:February 28, 2022
Contact:Joshua Freeman

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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.

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
We found this trial at
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Daniel Katz, M.D.
Phone: 845-437-3804
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
Poughkeepsie, NY
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Arlington Heights, Illinois 60004
Principal Investigator: Randall Kahan, M.D.
Phone: 847-221-4241
Arlington Heights, IL
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7580 Buckingham Boulevard
Hanover, Maryland 21076
Principal Investigator: Kaiser Robertson, M.D.
Phone: 443-471-5763
Hanover, MD
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Owings Mills, Maryland 21117
Principal Investigator: Andrew Shapiro, M.D.
Phone: 443-231-1203
Owings Mills, MD
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Shreveport, Louisiana 71106
Principal Investigator: Kevin Cline, M.D.
Phone: 318-683-0411
Shreveport, LA
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Virginia Beach, Virginia 23462
Principal Investigator: Kurt McCammon, M.D.
Phone: 757-452-3421
Virginia Beach, VA
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