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Vesair Balloon Confirmatory Trial (VECTOR)

Sponsor
Solace Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03794206
Collaborator
(none)
20
Enrollment
8
Locations
1
Arm
38.5
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vesair Balloon
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 11, 2019
Actual Primary Completion Date :
Aug 26, 2019
Actual Study Completion Date :
Apr 28, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Provocative Pad Weight [3 months]

    in-office Pad weight test

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WomanCare Arlington Heights Illinois United States 60004
2 Regional Urology Shreveport Louisiana United States 71106
3 Chesapeake Urology Hanover Maryland United States 21076
4 Chesapeake Urology Owings Mills Maryland United States 21117
5 Premier Medical Group of the Hudson Valley Poughkeepsie New York United States 12601
6 Women and Infants dept of Urogynecology Providence Rhode Island United States 02903
7 Urology of Virginia Virginia Beach Virginia United States 23462
8 Washington Urology Kirkland Washington United States 98034

Sponsors and Collaborators

  • Solace Therapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03794206
Other Study ID Numbers:
  • CD1009
First Posted:
Jan 4, 2019
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress

Study Results

No Results Posted as of Jun 13, 2022