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TVT-SECUR as an Office-based Procedure

2014-07-23 21:08:52 | BioPortfolio

Summary

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 acceptance of the procedure. Success would be assessed by validated questionnaires.

This is a prospective single arm study of 20 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 1 year.

Description

The study will include 20 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Urinary Incontinence

Intervention

Gynecare TVT-SECUR system

Location

Advanced Urogynecology of Michigan PC
Dearborn
Michigan
United States
48124

Status

Active, not recruiting

Source

Michigan Institution of Women's Health PC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:52-0400

Clinical Trials [730 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...

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

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 operati...

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...

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 ...

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.

PubMed Articles [9136 Associated PubMed Articles listed on BioPortfolio]

Determinants in the process of seeking help for urinary incontinence in the Chilean health system.

To analyze via the Andersen model what leads women with urinary incontinence (UI) to seek help and remain in the health care system.

Anaphylactoid Reactions after Instillation of Contrast Material into the Urinary Tract: A Survey of Contemporary Practice Patterns and Review of the Literature.

To assess drug reactions (ADRs) encountered by practicing urologists for contrast instilled into the urinary collecting system, and to describe current practice patterns regarding contrast administrat...

Medical and surgical interventions for the treatment of urinary stones in children.

Urolithiasis is a condition where crystalline mineral deposits (stones) form within the urinary tract. Urinary stones can be located in any part of the urinary tract. Affected children may present wit...

The urinary microbiome in women with mixed urinary incontinence compared to similarly aged controls.

Previous studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed fro...

Adenomyosis and urinary system symptoms.

This study aims to investigate the presence and incidence of overactive bladder (OAB) syndrome in patients diagnosed with adenomyosis and to evaluate the impacts of urinary symptoms on the quality of ...

Medical and Biotech [MESH] Definitions

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

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.

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.

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.

A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes, and the genital tract in the male. Common urological problems include urinary obstruction, URINARY INCONTINENCE, infections, and UROGENITAL NEOPLASMS.

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