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Clinical Evaluation of the Needleless® Sling

2014-08-27 03:16:27 | BioPortfolio

Summary

Urinary incontinence which is a major health issue in women affects 30-40% of older women.

Surgical treatments for SUI have undergone many modifications in the last century.

The Needleless Sling System is a one incision, minimally invasive, surgical procedure that has had great acceptance in Europe and has recently received FDA Clearance for use in the United States.

We will evaluate effectiveness and patient reported outcomes for Needleless® sling system (Neomedic International).

This is a prospective, multicenter, registry. Up to 150 women will be enrolled from up to 3 registry sites.

Patients will be evaluated at baseline, peri-operatively, and post-operatively up to 2 months, up to 6 months and at 12 months.

Effectiveness evaluations will include a standing stress test (objective cure), SANDVIK questions (subjective cure) & I-QOL (quality of life measure).

Other evaluations will include type of anesthesia, concurrent surgery, operative time, post-operative pain, length of hospital stay, returning to usual activities, change of lower urinary tract symptoms (BFLUTSSF, voiding diaries), goal achievement and patient satisfaction.

Study Design

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

Conditions

Stress Urinary Incontinence

Intervention

Needleless mid-urethral sling

Location

Samsung Medical Center
Seoul
Korea, Republic of

Status

Not yet recruiting

Source

Samsung Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:27-0400

Clinical Trials [1431 Associated Clinical Trials listed on BioPortfolio]

UI Treatment Network (TOMUS)

The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are c...

To Evaluate the Use of Bioresorbable Tephaflex™ Sling for Stress Urinary Incontinence

Urinary incontinence (UI) is a major public health issue affecting up to 25-50% of all women and has a detrimental impact on patient quality of life. Stress urinary incontinence (SUI) is t...

Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence

Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as ef...

Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence

This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decr...

Randomized Control Trial to Assess Postoperative Pain After Sling Placement

There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This st...

PubMed Articles [7254 Associated PubMed Articles listed on BioPortfolio]

Retrospective study on the management and follow-up of 18 patients with a mid-urethral sling penetrating the urethra or bladder.

The mid-urethral sling (MUS) procedure is the gold-standard for the surgical treatment of stress urinary incontinence (SUI). Urethro-vesical sling exposure is one of the most serious complications of ...

Do urodynamic findings influence the approach to mid-urethral sling surgery for stress urinary incontinence?

Recent press coverage on vaginal mesh surgery has resulted in a change in how patients are counselled, managed and treated in the UK. For stress urinary incontinence surgical procedures such as insert...

Predictors of sling revision after mid-urethral sling procedures: a case-control study.

To identify patient characteristics and surgical factors predictive of complications requiring mid-urethral sling (MUS) revision/removal.

Sling Plication for Failed Midurethral Sling Procedures: A Case Series.

The aim of this article is to report the outcomes of sling plications performed on women who presented with persistent stress urinary incontinence after midurethral sling.

Reply to Letter-to-the-Editor, Re: Linder Et Al: Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-Term Outcomes.

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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