Clinical Evaluation of the Needleless® Sling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054833
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: Needleless mid-urethral sling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Needleless® Sling for the Treatment of Female Stress Urinary Incontinence
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Needleless sling
Needleless® sling
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.

Primary Outcome Measures :
  1. The result of standing cough stress test at 12 months. [ Time Frame: 12 months after the Needleless sling operation ]

Secondary Outcome Measures :
  1. Sandvik Index Questionnaire [ Time Frame: 2, 6, 12 months after the Needleless sling operation ]
  2. Subjective symptom assessment by visual analogue scale [ Time Frame: 2, 6, 12 months after the Needleless sling operation ]
  3. Post-Operative Pain Assessment [ Time Frame: postop, 2 months after the Needleless sling operation ]
  4. Return to Usual Activities Questionnaire [ Time Frame: 2 months after the Needleless sling operation ]
  5. Standing Cough Stress Test [ Time Frame: 6, 12 months after the Needleless sling operation ]
  6. Incontinence Quality of Life Questionnaires (I-QOL) [ Time Frame: 6, 12 months after the Needleless sling operation ]
  7. BFLUTS-SF questionnaire [ Time Frame: 6, 12 months after the Needleless sling operation ]
  8. Patient Satisfaction Questionnaire [ Time Frame: 12 months after the Needleless sling operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

A patient must satisfy the following criteria before entering the study:

  1. 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.
  2. Patient is age 18 or older.
  3. 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.
  4. 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:

    1. Patient has an associated or suspected neurological disease.
    2. Patient is on anti-coagulation therapy.
    3. Patient has received an investigational drug or device in the past 60 days.
    4. Patient has an active lesion or present injury to perineum or urethra.
    5. Patient has a urethral obstruction.
    6. Patient has a significant cystocele > ICS Stage 2.
    7. The subject has active infection upon urine dipstick analysis, defined as ≥ +1 leukocytes or ≥ +1 nitrates (Must reschedule appointment after UTI resolves.)
    8. Patients with combined POP surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054833

Korea, Republic of
Asan Medical center, Ulsan College of Medicine
Seoul, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center Identifier: NCT01054833     History of Changes
Other Study ID Numbers: 2009-11-019
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders