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Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
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ClinicalTrials.gov Identifier: NCT00527696
(statistical Significance was reached for primary outcome)
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.
Women with predominantly symptoms of urge urinary incontinence
Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
Detrusor overactivity on cystometrogram at urodynamic testing
Previous surgery for incontinence
Intrinsic sphincter deficiency (MUCP<20 cm H2O or Q -tip <30o)
Voiding dysfunction with postvoid residual >100 cc