Trial Information

Over 11 million women in the United States suffer from stress urinary incontinence (SUI), the involuntary leakage of urine during routine physical activities such as laughing, coughing, exercising, or sneezing. SUI affects women of all ages and can result in significant emotional distress. The purpose of this study is to evaluate a non-surgical, investigational treatment intended to reduce or eliminate urine leakage due to stress urinary incontinence.

Patient Inclusion Criteria:

• Female subjects > or equal to 18 years of age.
• Experienced stress urinary incontinence (SUI) for at least 12-months and failed prior non-surgical treatment
• VLPP > or equal to 60cm H20
• Stamey Grade > or equal to 1
• Free of local skin infection, impassable urethral strictures, trauma or necrosis
• Provide written informed consent

• Pregnant or planning pregnancy
• 3 or more urinary tract infections within previous year
• Intrinsic sphincter deficiency
• Incontinence surgery within previous 6-months
• Cystocele > or equal to Grade 3
• Previous pelvic radiation therapy
• Presence of urethral abnormalities
• Recent urosepsis
• History of interstitial or follicular cystitis
• Uncontrolled diabetes
• Biofeedback within previous 3 months
• Morbid obesity
• Use of anticoagulants other than aspirin

Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown NJ 07962
Phone: 973-660-3139
EMail: kelly.colucci@atlantichealth.org