Clinical Evaluation of the Needleless® Sling

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Needleless mid-urethral sling

• Registration Number: NCT01054833
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Needleless sling	Needleless mid-urethral sling	Needleless® sling

Primary Outcome Measures

Name	Time	Method
The result of standing cough stress test at 12 months.	12 months after the Needleless sling operation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Asan Medical center, Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University; 🇰🇷 Seoul, Korea, Republic of