Clinical Evaluation of the Needleless® Sling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01054833
First received: January 20, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Intervention
Stress Urinary Incontinence
Procedure: Needleless mid-urethral sling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Needleless® Sling for the Treatment of Female Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The result of standing cough stress test at 12 months. [ Time Frame: 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sandvik Index Questionnaire [ Time Frame: 2, 6, 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Subjective symptom assessment by visual analogue scale [ Time Frame: 2, 6, 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Post-Operative Pain Assessment [ Time Frame: postop, 2 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Return to Usual Activities Questionnaire [ Time Frame: 2 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Standing Cough Stress Test [ Time Frame: 6, 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Incontinence Quality of Life Questionnaires (I-QOL) [ Time Frame: 6, 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • BFLUTS-SF questionnaire [ Time Frame: 6, 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]
  • Patient Satisfaction Questionnaire [ Time Frame: 12 months after the Needleless sling operation ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054833

Locations
Korea, Republic of
Samsung Medical Center
Seoul, 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
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01054833     History of Changes
Other Study ID Numbers: 2009-11-019
Study First Received: January 20, 2010
Last Updated: May 29, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014