Advertisement

Topics

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 [658 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 [9190 Associated PubMed Articles listed on BioPortfolio]

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...

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 ...

The Paris system for reporting urinary cytology improves correlation with surgical pathology biopsy diagnoses of the lower urinary tract.

The current study seeks to compare both the original diagnoses (OD) and the updated Paris system diagnoses (PD) of urinary cytology specimens to the corresponding surgical pathology (biopsy) diagnoses...

The fabrication of 3D surface scaffold of collagen/poly (L-lactide-co-caprolactone) with dynamic liquid system and its application in urinary incontinence treatment as a tissue engineered sub-urethral sling: In vitro and in vivo study.

To fabricate a novel nanoyarn biomaterial via a dynamic liquid electrospinning system, and to simultaneously evaluate whether nanoyarn is capable of being applied as a urinary sling for future clinica...

Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi-center Iberian study.

To evaluate effectiveness and safety of the adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI).

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.

More From BioPortfolio on "TVT-SECUR as an Office-based Procedure"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Anesthesiology
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Stress
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...


Searches Linking to this Trial