Vesair Continued Access Trial

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

Single arm study of the Vesair Balloon in postmenopausal women.

Key facts

Study ID

NCT03082118

Run by

Solace Therapeutics, Inc.

People needed

7

Starts

2017-03-09

Expected to finish

2019-01-15

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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