Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-01 @ 12:28 AM
Study NCT ID:
NCT01054833
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2010-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Needleless® Sling
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the Needleless® Sling for the Treatment of Female Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: