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VESICAL: Vesair Continued Access Trial

Sponsor
Solace Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03082118
Collaborator
(none)
7
Enrollment
7
Locations
1
Arm
22.2
Actual Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single arm study of the Vesair Balloon in postmenopausal women.

Condition or Disease Intervention/Treatment Phase
  • Device: Vesair Bladder Control System
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All women enrolled are treated.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 :
Mar 9, 2017
Actual Primary Completion Date :
Jan 15, 2019
Actual Study Completion Date :
Jan 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vesair Arm

Subjects treated with the Vesair Bladder Control System at enrollment.

Device: Vesair Bladder Control System
Intravesical balloon
Other Names:
  • Vesair Balloon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement on patient-reported outcomes [3-12 months]

      Improvement reported on questionnaires

    Secondary Outcome Measures

    1. Reduction in leakage events [3-12 months]

      Reduction in leakage events reported on a voiding diary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Urology Los Angeles California United States 90027
    2 Kaiser Permanente Urogynecology San Diego California United States 92110
    3 Georgia Center for Women Atlanta Georgia United States 30312
    4 Regional Urology Shreveport Louisiana United States 71106
    5 Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania United States 18103
    6 Riddle Hospital, Main Line Health Media Pennsylvania United States 19063
    7 West Penn Hospital, Allegheny Health Network Pittsburgh Pennsylvania United States 15224

    Sponsors and Collaborators

    • Solace Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Solace Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03082118
    Other Study ID Numbers:
    • CD1007
    First Posted:
    Mar 17, 2017
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    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 Jul 5, 2019