Vesair Continued Access Trial (VESICAL)

July 2, 2019 updated by: Solace Therapeutics, Inc.

Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence

Single arm study of the Vesair Balloon in postmenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Urology
      • San Diego, California, United States, 92110
        • Kaiser Permanente Urogynecology
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Georgia Center For Women
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Media, Pennsylvania, United States, 19063
        • Riddle Hospital, Main Line Health
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital, Allegheny Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement on patient-reported outcomes
Time Frame: 3-12 months
Improvement reported on questionnaires
3-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in leakage events
Time Frame: 3-12 months
Reduction in leakage events reported on a voiding diary
3-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solace Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2017

Primary Completion (ACTUAL)

January 15, 2019

Study Completion (ACTUAL)

January 15, 2019

Study Registration Dates

First Submitted

March 11, 2017

First Submitted That Met QC Criteria

March 11, 2017

First Posted (ACTUAL)

March 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD1007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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