Clinical Evaluation of the Needleless® Sling

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


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


Stress Urinary Incontinence


Needleless mid-urethral sling


Samsung Medical Center
Korea, Republic of


Not yet recruiting


Samsung Medical Center

Results (where available)

View Results


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

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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.

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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.

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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.


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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