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TVT-SECUR A Pilot Study for the Treatment of Stress Urinary Incontinence

2014-08-27 03:38:57 | BioPortfolio

Summary

The primary objective of this study is to obtain clinical performance information on the GYNECARE TVT-SECUR* System (Tension-free Support for Incontinence) in women with stress urinary incontinence (SUI).

Description

The primary variable for effectiveness is > 50% improvement on the subjective symptom Visual Analog Scale (VAS) at Visit 3/Week 5 (35 days post-surgery) to be accepted.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Stress Urinary Incontinence

Intervention

GYNECARE TVT-SECUR* System

Location

Michigan Institute of Women's Health
Dearborn
Michigan
United States
48124

Status

Completed

Source

Ethicon, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:57-0400

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Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

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PubMed Articles [14963 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.

Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.

An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.

Support structures, made from natural or synthetic materials, that are implanted below the URETHRA to treat URINARY STRESS INCONTINENCE.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

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