Stress Urinary Incontinence Clinical Trial
Official title:
Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence
This is a prospective, non-randomized, observational, multicentre (5 sites) study in which
subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR
operative procedure.
The study will collect preoperative urologic testing, medical history, and subject quality
of life patient questionnaires, Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected
at intervals up to 24 months. The anatomic position of the device will be characterize by
transvaginal ultrasound testing.
To determine the rate and/or improvement rate of patients who have received the Gynecare
Secur device after 12 months and after 24 months.
n/a
Time Perspective: Prospective
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