Vesair Clinical Trial

NCT04026347 — Not applicable, Terminated, 158 participants, Solace Therapeutics, Inc.
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An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women

RegistryNCT04026347, acronym VAPOR
StatusTerminated - Missed endpoint
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment158 (Actual)
SponsorSolace Therapeutics, Inc. (Industry)
ConditionsStress Urinary Incontinence
InterventionsVesair Balloon, Sham balloon placement (Device, other)
Datesstart 2020-02-01, primary completion 2022-02-28, completion 2022-04-15, first posted 2019-07-19, last updated 2022-05-13
Locations25 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Stress Urinary Incontinence All trials of Vesair Balloon All trials of Sham balloon placement

-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
VesairExperimentalDevice: Vesair BalloonSubjects are treated with Vesair Balloon at enrollment (day 0)
ShamSham comparatorDevice: Vesair Balloon; Other: Sham balloon placementSubjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
  • Vesair Balloon (Device): Indwelling, intravesical balloon
  • Sham balloon placement (Other): Sham balloon placement procedure

+Outcome measures

Primary outcomes

  • Composite Endpoint [6 months]: Pad weight + I-QOL

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to any

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:

* 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

+Locations (25)

FacilityCityCountryStatus
Valley Urogynecology AssociatesPhoenix, ArizonaUnited States
Scripps ClinicSan Diego, CaliforniaUnited States
Tri Valley UrologyTemecula, CaliforniaUnited States
Dr. Sherry ThomasWestlake Village, CaliforniaUnited States
Women's Health Specialty CareFarmington, ConnecticutUnited States
Florida Urology PartnersTampa, FloridaUnited States
Meridian Clinical Research / Urological Associates of SavannahSavannah, GeorgiaUnited States
WomanCareArlington Heights, IllinoisUnited States
CMB Research / Basinski and Juran MDsNewburgh, IndianaUnited States
Regional UrologyShreveport, LouisianaUnited States
Chesapeake UrologyHanover, MarylandUnited States
Chesapeake UrologyOwings Mills, MarylandUnited States
Beth Israel Deaconess Medical Center (BIDMC)Boston, MassachusettsUnited States
Mercy HealthAda, MichiganUnited States
Freedman UrologyLas Vegas, NevadaUnited States
ProHEALTH Garden City UrologyGarden City, New YorkUnited States
Premier Medical Group of the Hudson ValleyPoughkeepsie, New YorkUnited States
Associated Urologists of North CarolinaRaleigh, North CarolinaUnited States
MetroHealthCleveland, OhioUnited States
Penn MedicinePhiladelphia, PennsylvaniaUnited States
Women and Infants dept of UrogynecologyProvidence, Rhode IslandUnited States
Houston Metro UrologyHouston, TexasUnited States
Urology San AntonioSan Antonio, TexasUnited States
Urology of VirginiaVirginia Beach, VirginiaUnited States
Washington UrologyKirkland, WashingtonUnited States

+Publications

  • Results publication: 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. PMID 29095516