Back to resultsClinical Evaluation of the Needleless® Sling
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Needleless mid-urethral sling
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- Asan Medical center, Ulsan College of Medicine
- Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Needleless sling
Arm Description
Needleless® sling
Outcomes
Primary Outcome Measures
The result of standing cough stress test at 12 months.
Secondary Outcome Measures
Sandvik Index Questionnaire
Subjective symptom assessment by visual analogue scale
Post-Operative Pain Assessment
Return to Usual Activities Questionnaire
Standing Cough Stress Test
Incontinence Quality of Life Questionnaires (I-QOL)
BFLUTS-SF questionnaire
Patient Satisfaction Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01054833
Brief Title
Clinical Evaluation of the Needleless® Sling
Official Title
A Clinical Evaluation of the Needleless® Sling for the Treatment of Female Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Needleless sling
Arm Type
Experimental
Arm Description
Needleless® sling
Intervention Type
Procedure
Intervention Name(s)
Needleless mid-urethral sling
Intervention Description
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 Measure Information:
Title
The result of standing cough stress test at 12 months.
Time Frame
12 months after the Needleless sling operation
Secondary Outcome Measure Information:
Title
Sandvik Index Questionnaire
Time Frame
2, 6, 12 months after the Needleless sling operation
Title
Subjective symptom assessment by visual analogue scale
Time Frame
2, 6, 12 months after the Needleless sling operation
Title
Post-Operative Pain Assessment
Time Frame
postop, 2 months after the Needleless sling operation
Title
Return to Usual Activities Questionnaire
Time Frame
2 months after the Needleless sling operation
Title
Standing Cough Stress Test
Time Frame
6, 12 months after the Needleless sling operation
Title
Incontinence Quality of Life Questionnaires (I-QOL)
Time Frame
6, 12 months after the Needleless sling operation
Title
BFLUTS-SF questionnaire
Time Frame
6, 12 months after the Needleless sling operation
Title
Patient Satisfaction Questionnaire
Time Frame
12 months after the Needleless sling operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical center, Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Needleless® Sling
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