Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

University of Manitoba

Status and phase: Terminated; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Procedure: transvaginal obturator tape

Study type: Interventional

Funder types: Other

Identifiers

NCT00527696

B2007:044

Details and patient eligibility

About

To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.

Enrollment: 106 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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106 participants in 2 patient groups

TVT SECURE

Active Comparator group

Description:

sling

Treatment:

Procedure: transvaginal obturator tape

TVT O

Active Comparator group

Description:

sling

Treatment:

Procedure: transvaginal obturator tape