Vesair Balloon Confirmatory Trial (VECTOR)

Stress Urinary Incontinence Clinical Trial

— VECTOR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03794206
• Other study ID #: CD1009
• Status: Terminated
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: April 28, 2022

Study information

• Verified date: June 2022
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 28, 2022
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Vesair Balloon
Treatment with Vesair Balloon for one year

Locations

Country	Name	City	State
United States	WomanCare	Arlington Heights	Illinois
United States	Chesapeake Urology	Hanover	Maryland
United States	Washington Urology	Kirkland	Washington
United States	Chesapeake Urology	Owings Mills	Maryland
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Women and Infants dept of Urogynecology	Providence	Rhode Island
United States	Regional Urology	Shreveport	Louisiana
United States	Urology of Virginia	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provocative Pad Weight	in-office Pad weight test	3 months

External Links

•   Company Website