Clinical Evaluation of the Needleless® Sling

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054833
• Other study ID #: 2009-11-019
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: May 29, 2013
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical center, Ulsan College of Medicine	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The result of standing cough stress test at 12 months.		12 months after the Needleless sling operation	No
Secondary	Sandvik Index Questionnaire		2, 6, 12 months after the Needleless sling operation	No
Secondary	Subjective symptom assessment by visual analogue scale		2, 6, 12 months after the Needleless sling operation	No
Secondary	Post-Operative Pain Assessment		postop, 2 months after the Needleless sling operation	No
Secondary	Return to Usual Activities Questionnaire		2 months after the Needleless sling operation	No
Secondary	Standing Cough Stress Test		6, 12 months after the Needleless sling operation	No
Secondary	Incontinence Quality of Life Questionnaires (I-QOL)		6, 12 months after the Needleless sling operation	No
Secondary	BFLUTS-SF questionnaire		6, 12 months after the Needleless sling operation	No
Secondary	Patient Satisfaction Questionnaire		12 months after the Needleless sling operation	No