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Completed

NCT Number: NCT01054833

Clinical Evaluation of the Needleless® Sling

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical center, Ulsan College of Medicine, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Needleless mid-urethral sling

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.

Primary outcomes

  1. The result of standing cough stress test at 12 months.

    Time frame: 12 months after the Needleless sling operation

Secondary outcomes

  1. Sandvik Index Questionnaire

    Time frame: 2, 6, 12 months after the Needleless sling operation

  2. Subjective symptom assessment by visual analogue scale

    Time frame: 2, 6, 12 months after the Needleless sling operation

  3. Post-Operative Pain Assessment

    Time frame: postop, 2 months after the Needleless sling operation

  4. Return to Usual Activities Questionnaire

    Time frame: 2 months after the Needleless sling operation

  5. Standing Cough Stress Test

    Time frame: 6, 12 months after the Needleless sling operation

  6. Incontinence Quality of Life Questionnaires (I-QOL)

    Time frame: 6, 12 months after the Needleless sling operation

  7. BFLUTS-SF questionnaire

    Time frame: 6, 12 months after the Needleless sling operation

  8. Patient Satisfaction Questionnaire

    Time frame: 12 months after the Needleless sling operation

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 22, 2010
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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