Clinical Evaluation of the Needleless® Sling

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Needleless mid-urethral sling

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2009-11-019