Vesair Continued Access Trial

Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03082118

Acronym

VESICAL

Enrollment

Registered

2017-03-17

Start date

2017-03-09

Completion date

2019-01-15

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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.

Interventions

DEVICEVesair Bladder Control System

Intravesical balloon

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

All women enrolled are treated.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement on patient-reported outcomes	3-12 months	Improvement reported on questionnaires

Secondary

Measure	Time frame	Description
Reduction in leakage events	3-12 months	Reduction in leakage events reported on a voiding diary

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026