TerminatedNCT04026347VAPORUpdated May 13, 2022

Vesair Clinical Trial

An interventional study of Vesair Balloon and Sham balloon placement in Stress Urinary Incontinence, sponsored by Solace Therapeutics, Inc.. Terminated at 25 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-13.

Sponsored by Solace Therapeutics, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated

Missed endpoint

From the registry’s dates

Primary completion was Feb 2022, 4 years 7 months ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 158
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study summary

Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women

Conditions studied

Stress Urinary Incontinence

Browse trials for

Urinary Incontinence, Stress 671

Keywords

SUI
Women
Incontinence

In context

Urinary Incontinence, Stress

671 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.

This study's enrollment of 158 is above the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Solace Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Post-menopausal women with SUI for at least 12 months
Average of at least one leak per day
Failed non-invasive treatment
Willing to undergo cystoscopy and a minimum of 5 visits over one year

Exclusion criteria

Exclusion Criteria:

BMI > 40.0
Last menstrual period within 12 months of enrollment
On birth control and/or oral hormone replacement therapy
Urge-predominant mixed incontinence
SUI due to intrinsic sphincter deficiency
Prior treatment with the Vesair Balloon
Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
Recurrent or recent (within the past 5 years) kidney stones
Recurrent or recent (within the past 3 months) Urinary Tract Infection
Stage 3 or higher cystocele (POP-Q)
Interstitial or follicular cystitis / painful bladder syndrome
Local genital infection
Artificial sphincter
Anatomic abnormalities which would interfere with device placement.
Visible blood in the urine
Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
History of cancer of the urinary tract
History of any cancer within the past two years (excluding non-melanoma skin cancers)
History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
Immunologically suppressed or immunocompromised
Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
Non ambulatory / unable to do simple pad weight testing exercises
On anticoagulation therapy with the exception of aspirin
History of mental illness requiring inpatient treatment
Neurological disease such as Parkinson's or multiple sclerosis
Uncontrolled diabetes (A1C > 9%)
Recent alcohol or drug abuse requiring treatment in the past year
Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
Allergy to polyurethane or perfluorocarbons

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 158 participants (actual)

Study arms

Experimental
Vesair
Subjects are treated with Vesair Balloon at enrollment (day 0)
Device: Vesair Balloon
Sham comparator
Sham
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
Device: Vesair Balloon · Other: Sham balloon placement

Interventions

DeviceVesair Balloon
Indwelling, intravesical balloon
OtherSham balloon placement
Sham balloon placement procedure

What researchers measure

Primary outcomes

Composite Endpoint
Pad weight + I-QOL
Time frame: 6 months

Secondary outcomes

Pad Weight
Reduction in pad weight
Time frame: 6 months
I-QOL
Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
Time frame: 6 months
Episode Frequency
Reduction in episode frequency as reported on a 7 day diary
Time frame: 6 months
Patient Global Impression of Improvement (PGI-I)
Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)
Time frame: 6 months

Study locations

25 sites

Valley Urogynecology Associates
Phoenix, Arizona 85016, United States
Scripps Clinic
San Diego, California 92130, United States
Tri Valley Urology
Temecula, California 92592, United States
Dr. Sherry Thomas
Westlake Village, California 91361, United States
Women's Health Specialty Care
Farmington, Connecticut 06032, United States
Florida Urology Partners
Tampa, Florida 33615, United States
Meridian Clinical Research / Urological Associates of Savannah
Savannah, Georgia 31405, United States
WomanCare
Arlington Heights, Illinois 60004, United States
CMB Research / Basinski and Juran MDs
Newburgh, Indiana 47630, United States
Regional Urology
Shreveport, Louisiana 71106, United States
Chesapeake Urology
Hanover, Maryland 21076, United States
Chesapeake Urology
Owings Mills, Maryland 21117, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02210, United States
Mercy Health
Ada, Michigan 49301, United States
Freedman Urology
Las Vegas, Nevada 89144, United States
ProHEALTH Garden City Urology
Garden City, New York 11530, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York 12601, United States
Associated Urologists of North Carolina
Raleigh, North Carolina 27612, United States
MetroHealth
Cleveland, Ohio 44109, United States
Penn Medicine
Philadelphia, Pennsylvania 19041, United States
Women and Infants dept of Urogynecology
Providence, Rhode Island 02903, United States
Houston Metro Urology
Houston, Texas 77027, United States
Urology San Antonio
San Antonio, Texas 78229, United States
Urology of Virginia
Virginia Beach, Virginia 23462, United States
Washington Urology
Kirkland, Washington 98034, United States

References and documents

Publications

McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2. PubMed 29095516 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Feb 2022, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 17, 2019
First posted: Jul 19, 2019
StartActual: Feb 1, 2020
Primary completionActual: Feb 28, 2022
CompletionActual: Apr 15, 2022
Last update: May 13, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04026347
Lead sponsor: Solace Therapeutics, Inc.
Responsible party: Sponsor
First posted: Jul 19, 2019
Start date: Feb 1, 2020
Primary completion: Feb 28, 2022
Completion: Apr 15, 2022
Last update: May 13, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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