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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

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PubMed Articles [6874 Associated PubMed Articles listed on BioPortfolio]

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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.

Re: Linder et al.:Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-Term Outcomes (Urology. 2016 Jul;93:55-9).

Titanised Transobturator Sling Placement for Male Stress Urinary Incontinence Using an Inside-Out Single-Incision Technique: Minimum 12-Months Follow-Up Study.

To evaluate prospectively midterm outcomes of a new titanium-coated fixed polypropylene sling for male stress urinary incontinence.

Does Mid-Urethral Sling Surgery in the Treatment of Stress Urinary Incontinence Affect Weight Changes in Women? A Retrospective Cohort Study Using Internal Controls.

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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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