NCT01054833

Clinical Evaluation of the Needleless® Sling

A Clinical Evaluation of the Needleless® Sling for the Treatment of Female Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Needleless mid-urethral sling	The Needleless® sling is intended for use in women as a tension free, sub-urethral slings for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Needleless sling is a macroporous, monofilament, knitted polypropylene featuring 'Pocket Positioning Anchors' which allow sling placement without needle introducers; thus eliminating a complicated aspect of the surgery (TVT/TOT) and reducing the potential for bladder injury or inguinal pain that can occur during transobturator needle passage. The Needleless sling was approved by KFDA, and now is available in worldwide including Korea.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-01-22
• Last updated: 2013-05-30

Locations

3 sites across 1 country: South Korea