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

2014-08-27 03:17:24 | BioPortfolio

Summary

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.

Study Design

Time Perspective: Prospective

Conditions

Stress Urinary Incontinence

Intervention

Gynecare TVT Secur

Location

Sunnybrook Health Sciences Centre
Toronto
Ontario
Canada
M4N 3M5

Status

Recruiting

Source

Sunnybrook Health Sciences Centre

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:24-0400

Clinical Trials [1228 Associated Clinical Trials listed on BioPortfolio]

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

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 inc...

Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT...

TVT-SECUR as an Office-based Procedure

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptan...

Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence

The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.

Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia

The objective was to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR for the treatment of stress urinary incontinence, with the use of questionnaires ...

PubMed Articles [6811 Associated PubMed Articles listed on BioPortfolio]

The efficacy and safety comparison of surgical treatments for stress urinary incontinence: A network meta-analysis.

Stress urinary incontinence (SUI) is a common problem worldwide. Mainstream surgical procedures include tension-free vaginal tape (TVT), transobturator tape (TOT), tension-free vaginal tape-obturator ...

EFFECT OF DELIVERY AND EPISIOTOMY ON THE EMERGENCE OF URINARY INCONTINENCE IN WOMEN: REVIEW OF LITERATURE.

Episiotomy is obstetric procedure during which the incision extends the vestibule of the vagina during the second stage of labor. Episiotomy was extensively spread with gradual increase of rates in th...

Comparison of adjustable continence therapy periurethral balloons and artificial urinary sphincter in female patients with stress urinary incontinence due to intrinsic sphincter deficiency.

The objective was to compare the outcomes of the ACT® device with those of the artificial urinary sphincter (AUS) AMS 800 in the treatment of stress urinary incontinence (SUI) due to sphincter defici...

Adult male stress and urge urinary incontinence - A review of pathophysiology and treatment strategies for voiding dysfunction in men.

Male urinary incontinence adversely affects health-related quality of life and is associated with significant psychosexual and financial burden. The two most common forms of male incontinence are stre...

Long-term follow-up of bulking agents for stress urinary incontinence in older patients.

Implantation of bulking agents represents a noninvasive procedure for the treatment of stress urinary incontinence (SUI) in all patients where a more invasive procedure may increase perioperative risk...

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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