Clinical Evaluation of the Needleless® Sling

NCT ID: NCT01054833

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-02-28

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Needleless sling

Needleless® sling

Group Type: EXPERIMENTAL

Needleless mid-urethral sling

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

KYU-SUNG LEE

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu-Sung Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Asan Medical center, Ulsan College of Medicine

Seoul, , South Korea

Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Reference Type: DERIVED

PMID: 37888839 (View on PubMed)

Other Identifiers

2009-11-019

Identifier Type: -

Identifier Source: org_study_id