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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TVT SECURE

sling

Group Type ACTIVE_COMPARATOR

transvaginal obturator tape

Intervention Type PROCEDURE

TVT O

sling

Group Type ACTIVE_COMPARATOR

transvaginal obturator tape

Intervention Type PROCEDURE

Interventions

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transvaginal obturator tape

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes