Vesair Continued Access Trial

Solace Therapeutics, Inc.7 enrolled

Overview

Single arm study of the Vesair Balloon in postmenopausal women.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Interventions

Vesair Bladder Control SystemDEVICE

Intravesical balloon

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

Improvement on patient-reported outcomes

Improvement reported on questionnaires

Time frame: 3-12 months

Secondary Outcomes

Reduction in leakage events

Reduction in leakage events reported on a voiding diary

Time frame: 3-12 months

Data from ClinicalTrials.gov

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