Clinical trial NCT01054833: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The result of standing cough stress test at 12 months.
timeFrame: 12 months after the Needleless sling operation
Secondary outcomes:
measure: Sandvik Index Questionnaire
timeFrame: 2, 6, 12 months after the Needleless sling operation
measure: Subjective symptom assessment by visual analogue scale
timeFrame: 2, 6, 12 months after the Needleless sling operation
measure: Post-Operative Pain Assessment
timeFrame: postop, 2 months after the Needleless sling operation
measure: Return to Usual Activities Questionnaire
timeFrame: 2 months after the Needleless sling operation
measure: Standing Cough Stress Test
timeFrame: 6, 12 months after the Needleless sling operation
measure: Incontinence Quality of Life Questionnaires (I-QOL)
timeFrame: 6, 12 months after the Needleless sling operation
measure: BFLUTS-SF questionnaire
timeFrame: 6, 12 months after the Needleless sling operation
measure: Patient Satisfaction Questionnaire
timeFrame: 12 months after the Needleless sling operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical center, Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: