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Trial record 5 of 6 for:    solace | stress incontinence

Vesair Balloon Confirmatory Trial (VECTOR) (VECTOR)

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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.

Tracking Information
First Submitted Date  ICMJE January 3, 2019
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE February 11, 2019
Actual Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
Provocative Pad Weight [ Time Frame: 3 months ]
in-office Pad weight test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vesair Balloon Confirmatory Trial (VECTOR)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Device: Vesair Balloon
Treatment with Vesair Balloon for one year
Study Arms  ICMJE Experimental: Treatment Arm
Single-arm of subjects who receive treatment with Vesair Balloon
Intervention: Device: Vesair Balloon
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)
25
Estimated Study Completion Date  ICMJE June 28, 2022
Actual Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03794206
Other Study ID Numbers  ICMJE CD1009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Solace Therapeutics, Inc.
Study Sponsor  ICMJE Solace Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles Rardin, M.D. Women and Infants Hospital
PRS Account Solace Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP