The AttenueX IntraVesical System for the Treatment of Female Stress Urinary Incontinence

A multicenter, prospective, randomized, single-blinded, two-arm longitudinal trial of the safety and effectiveness of the AttenueX Device in reducing incontinence. Subjects randomized to the control arm will have the AttenueX Device inserted at the end of the 3-month control period. For those subjects who are randomized to the treatment group, the AttenueX Device will be inserted into the bladder on Day 0, and replaced every 90 days by a new device for nine months. Subjects randomized into the treatment group will be followed for a minimum of 12 months after receiving the AttenueX Device, while subjects randomized into the control group will be followed for 3 months without the AttenueX Device and a minimum of 12 months after receiving the AttenueX Device.

Inclusion criteria

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

Exclusion criteria

• Pregnant or planning pregnancy
• 3 or more urinary tract infections within previous year
• Intrinsic sphincter deficiency
• Incontinence surgery within previous 6-months
• Cystocele ≥ 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