Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)

This is an interventional treatment trial for Female Stress Urinary Incontinence Read More

Inclusion Criteria:

• Female, age at least 18 years
• Have signed an Informed Consent Form
• Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST
• Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling

Exclusion Criteria:

• Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device
• Patient is known to be pregnant or desiring future childbearing
• Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation
• Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure
• Patient requires concurrent correction of pelvic organ prolapse
• Patient has a history of previous sling procedure
• Patient has known history of detrusor overactivity demonstrated by urodynamics
• Patient has known urinary retention
• Patient has a current genitourinary fistula or urinary diverticulum
• Patient has a prior history of pelvic radiation
• Patient has a MESA urge symptom score (% of total possible urge score) that is greater than their MESA stress symptom score (% of total possible stress score)
• Any condition in the opinion of the Investigator that would preclude the use of the Ajust™ Adjustable Single-Incision Sling, or preclude the subject from completing the follow-up requirements