Clinical Evaluation of the Needleless® Sling

Samsung Medical Center

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Procedure: Needleless mid-urethral sling

Study type

Interventional

Funder types

Other

Identifiers

NCT01054833

2009-11-019

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
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.