Vesair Continued Access Trial

Stress Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082118
• Other study ID #: CD1007
• Status: Completed
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: July 2019
• Source: Solace Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single arm study of the Vesair Balloon in postmenopausal women.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Vesair Bladder Control System
Intravesical balloon

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Georgia Center for Women	Atlanta	Georgia
United States	Kaiser Permanente Urology	Los Angeles	California
United States	Riddle Hospital, Main Line Health	Media	Pennsylvania
United States	West Penn Hospital, Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Urogynecology	San Diego	California
United States	Regional Urology	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Solace Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement on patient-reported outcomes	Improvement reported on questionnaires	3-12 months
Secondary	Reduction in leakage events	Reduction in leakage events reported on a voiding diary	3-12 months