Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence

Inclusion Criteria

• •Female greater than 18 years of age
• •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• •Diagnosed with genuine SUI confirmed by urodynamic evaluation (urodynamic evaluations performed in the past 6 months are acceptable) and documented in the source documents as in patients charts, physicians notes, nurses notes, hospital records, etc.
• •If the patient has an overactive bladder, the condition must be a minor component of the patient's disorder demonstrated by the urodynamic testing. This is a physician
• •discretion for inclusion or exclusion in the study.
• •Patients are willing to complete (PFDI-short form 20) and PISQ-12 at baseline, 3 months, 6 months and 12 months post-operatively.
• •Patient has documented SUI classification and the degree of hypermobility and/ or intrinsic sphincter abnormality (Q-Tip test). Confirm the patient's SUI diagnosis using one or more of the following procedures:
• •* Vaginal exam
• •* Cough provocation test
• •* Cystoscopic exam
• •Patients must have a negative urine culture
• •Patients' bladder capacity of 350cc or more
• •Document voiding diary pre- and post-operatively
• •Document post-void residual (PVR) of equal to or less than 100cc
• •Patients that require a regional, general anesthesia or monitored anesthesia
• •Pad test on baseline that demonstrate 5 grams or greater urine loss
• •Patients are mentally competent and able to understand all study requirements
• •Patients agree to read and sign the informed consent form prior to any study related procedures (screening/ baseline visit)