Clinical Evaluation of the Needleless® Sling

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Needleless mid-urethral sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient must satisfy the following criteria before entering the study: Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test. Patient is age 18 or older. Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent. Exclusion Criteria: A patient who meets any of the following criteria will be excluded from participating in the study: Patient has an associated or suspected neurological disease. Patient is on anti-coagulation therapy. Patient has received an investigational drug or device in the past 60 days. Patient has an active lesion or present injury to perineum or urethra. Patient has a urethral obstruction. Patient has a significant cystocele > ICS Stage 2. The subject has active infection upon urine dipstick analysis, defined as ≥ +1 leukocytes or ≥ +1 nitrates (Must reschedule appointment after UTI resolves.) Patients with combined POP surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needleless sling<br>Needleless® sling | Procedure: Needleless mid-urethral sling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The result of standing cough stress test at 12 months. |  | 12 months after the Needleless sling operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sandvik Index Questionnaire |  | 2, 6, 12 months after the Needleless sling operation | 
| Subjective symptom assessment by visual analogue scale |  | 2, 6, 12 months after the Needleless sling operation | 
| Post-Operative Pain Assessment |  | postop, 2 months after the Needleless sling operation | 
| Return to Usual Activities Questionnaire |  | 2 months after the Needleless sling operation | 
| Standing Cough Stress Test |  | 6, 12 months after the Needleless sling operation | 
| Incontinence Quality of Life Questionnaires (I-QOL) |  | 6, 12 months after the Needleless sling operation | 
| BFLUTS-SF questionnaire |  | 6, 12 months after the Needleless sling operation | 
| Patient Satisfaction Questionnaire |  | 12 months after the Needleless sling operation |