Stress Urinary Incontinence
Conditions
Keywords
SUI, Women, Incontinence
Brief summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Interventions
DEVICEVesair Balloon
Indwelling, intravesical balloon
OTHERSham balloon placement
Sham balloon placement procedure
Sponsors
Solace Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subject and assessor blinded to randomization result
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint | 6 months | Pad weight + I-QOL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed