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Vesair Continued Access Trial (VESICAL)

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vesair Bladder Control System
Sponsored by
Solace Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Urology
  • Kaiser Permanente Urogynecology
  • Georgia Center for Women
  • Regional Urology
  • Institute for Female Pelvic Medicine and Reconstructive Surgery
  • Riddle Hospital, Main Line Health
  • West Penn Hospital, Allegheny Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vesair Arm

Arm Description

Subjects treated with the Vesair Bladder Control System at enrollment.

Outcomes

Primary Outcome Measures

Improvement on patient-reported outcomes
Improvement reported on questionnaires

Secondary Outcome Measures

Reduction in leakage events
Reduction in leakage events reported on a voiding diary

Full Information

First Posted
March 11, 2017
Last Updated
July 2, 2019
Sponsor
Solace Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03082118
Brief Title
Vesair Continued Access Trial
Acronym
VESICAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solace Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single arm study of the Vesair Balloon in postmenopausal women.
Detailed Description
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All women enrolled are treated.
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vesair Arm
Arm Type
Experimental
Arm Description
Subjects treated with the Vesair Bladder Control System at enrollment.
Intervention Type
Device
Intervention Name(s)
Vesair Bladder Control System
Other Intervention Name(s)
Vesair Balloon
Intervention Description
Intravesical balloon
Primary Outcome Measure Information:
Title
Improvement on patient-reported outcomes
Description
Improvement reported on questionnaires
Time Frame
3-12 months
Secondary Outcome Measure Information:
Title
Reduction in leakage events
Description
Reduction in leakage events reported on a voiding diary
Time Frame
3-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kaiser Permanente Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Urogynecology
City
San Diego
State/Province
California
ZIP/Postal Code
92110
Country
United States
Facility Name
Georgia Center for Women
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Institute for Female Pelvic Medicine and Reconstructive Surgery
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Riddle Hospital, Main Line Health
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
West Penn Hospital, Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vesair Continued Access Trial

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