A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)

Inclusion criteria

• Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
• Patient is age 18 or older.
• Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
• Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.

Exclusion criteria

• Patient has an associated or suspected neurological disease.
• Patient is on anti-coagulation therapy.
• Patient has received an investigational drug or device in the past 60 days.

For patients having URP measurements at selected sites:

• Patient has an active lesion or present injury to perineum or urethra.Patient has a urethral obstruction.
• Patient has an unreduced cystocele > Stage 1. (Reduction of prolapse prior to URP testing is required.) Reduction of Cystocele (if applicable). Patients should be seated in a semi-fowler's position with head of bed at 40-60 degrees.

Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. Be careful not to over extend or elongate the vaginal length.

The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.

• The subject has active infection upon urine dipstick analysis, defined as ≥+1 leukocytes or ≥+1 nitrates (Must reschedule appointment after UTI resolves.)