Vesair Clinical Trial

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04026347
• Lead Sponsor: Solace Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2020-02-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Endpoint	6 months	Pad weight + I-QOL

Secondary Outcome Measures

Name	Time	Method
Episode Frequency	6 months	Reduction in episode frequency as reported on a 7 day diary
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)
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)

Trial Locations

Locations (24)

Valley Urogynecology Associates; 🇺🇸 Phoenix, Arizona, United States

Scripps Clinic; 🇺🇸 San Diego, California, United States

Tri Valley Urology; 🇺🇸 Temecula, California, United States

Dr. Sherry Thomas; 🇺🇸 Westlake Village, California, United States

Women's Health Specialty Care; 🇺🇸 Farmington, Connecticut, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Meridian Clinical Research / Urological Associates of Savannah; 🇺🇸 Savannah, Georgia, United States

WomanCare; 🇺🇸 Arlington Heights, Illinois, United States

CMB Research / Basinski and Juran MDs; 🇺🇸 Newburgh, Indiana, United States

Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

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