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Vesair Continued Access Trial (VESICAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03082118
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.

Brief Summary:
Single arm study of the Vesair Balloon in postmenopausal women.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Vesair Bladder Control System Not Applicable

Detailed Description:
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All women enrolled are treated.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vesair Arm
Subjects treated with the Vesair Bladder Control System at enrollment.
Device: Vesair Bladder Control System
Intravesical balloon
Other Name: Vesair Balloon




Primary Outcome Measures :
  1. Improvement on patient-reported outcomes [ Time Frame: 3-12 months ]
    Improvement reported on questionnaires


Secondary Outcome Measures :
  1. Reduction in leakage events [ Time Frame: 3-12 months ]
    Reduction in leakage events reported on a voiding diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women with SUI or stress predominant mixed incontinence
  • Maximum score on IQOL of 60
  • Positive cough test for leakage
  • Willing to undergo procedures
  • Free from infection
  • Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

  • SUI due to SUI
  • Urge-predominant mixed incontinence
  • Incontinence of neurogenic etiology
  • 2 or more UTIs in past year and 1 in past 3 months
  • Surgery for SUI in the past 6 months
  • taking medication that can be used to treat SUI
  • taking medication that affects urinary symptoms for less than 3 months
  • undergoing biofeedback
  • Grade 3 or worse cystocele
  • last menstrual period within 12 months
  • oral progesterone or estrogen in the past 12 months
  • BMI > 40
  • involuntary detrusor contractions or discomfort during bladder filling
  • previous stage III or worse cancer
  • previous cancer of the urinary tract
  • previous symptoms for early stage cancer in the past 2 years
  • anticoagulation therapy other than aspirin
  • history of prosthetic heart valve
  • neurological or connective tissue condition or disease affecting bladder function
  • known allergy to device components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082118


Locations
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United States, California
Kaiser Permanente Urology
Los Angeles, California, United States, 90027
Kaiser Permanente Urogynecology
San Diego, California, United States, 92110
United States, Georgia
Georgia Center for Women
Atlanta, Georgia, United States, 30312
United States, Louisiana
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, Pennsylvania
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
Riddle Hospital, Main Line Health
Media, Pennsylvania, United States, 19063
West Penn Hospital, Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Solace Therapeutics, Inc.
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Responsible Party: Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03082118    
Other Study ID Numbers: CD1007
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders