Vesair Continued Access Trial (VESICAL)

Solace Therapeutics

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Vesair Bladder Control System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03082118

CD1007

Details and patient eligibility

About

Single arm study of the Vesair Balloon in postmenopausal women.

Full description

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

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Vesair Arm

Experimental group

Description:

Subjects treated with the Vesair Bladder Control System at enrollment.

Treatment:

Device: Vesair Bladder Control System