An Evaluation of the Vesair® Bladder Control System in the Treatment of Female Subjects with Stress Urinary Incontinence - Vesair® Intravesical Pressure Study (VIP Study)

Solace Therapeutics, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

试验速览

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•- Eighteen years of age or older with predominant SUI as evidenced by visual confirmation during stress maneuvers
•- Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment (behavior modification, bladder training exercises, pelvic muscle rehabilitation, biofeedback, electrical stimulation or drug therapy) while incontinent.
•- Willing to undergo cystoscopic and video urodynamics procedures required during the initial study period.

•- Pregnant or planning pregnancy during the next 12 months
•- Morbid obesity, defined as BMI *40
•- History of urosepsis, bladder infection (including bladder inflammation or edema), urethral inflammation, urethral edema, urinary tract infection or asymptomatic bacteriuria within the past 3 months
•- Recurrent urinary tract infections (* 3 in the past 12 months)
•- Prior surgical procedure for incontinence within the past 6 months (including suburethral sling placement and/or removal)
•- Urinary incontinence of neurogenic etiology
•- History of recurrent (>1) kidney stones, or one within the past 5 years

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