Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

Not Applicable

• Conditions: Female Stress Urinary Incontinence
• Interventions: Device: Alma Lasers Pixel carbon dioxide laser system

• Registration Number: NCT02981654
• Lead Sponsor: Sheba Medical Center

Brief Summary

This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).

Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

Detailed Description

Improvement in SUI symptoms as measured by the following parameters:

Objective parameters:

* Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:

* Number of incontinence episodes per day

* Number of pads used per day

* Change from baseline in 1 hour pad test 1, 2, 6 and 12 months

* Change from baseline as assessed with Vaginal Biopsy

Subjective parameters:

* Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months

* Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months

* Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months

* Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months

Study Timeline

• Study First Submitted: 2016-10-30
• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-04
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Females between 30 and 75 years of age
• Provided written Informed Consent
• Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]
• Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
• Normal Papanicolaou smear (up to 1 year prior to screening)
• Negative urine culture
• Vaginal canal, introitus and vestibule free of injuries and bleeding
• Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).

Exclusion Criteria

• Positive pregnancy test
• Planned pregnancy within the next year
• Severe prolapse (POP>= grade 3)
• Use of photosensitive drugs
• Injury or/and active infection in the treatment area
• Active vaginal infection
• human papillomavirus/herpes simplex virus
• Undiagnosed vaginal bleeding
• Urge or overflow incontinence
• Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
• Patients with immune system diseases.
• Patients with allergic reaction to laser.
• Patient under treatment with photosensitivity side effects medication.
• Obese women (BMI >30)
• Patient unable to follow post treatment instructions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Femilift treatment	Alma Lasers Pixel carbon dioxide laser system	The Alma Lasers Pixel carbon dioxide laser system delivers fractionated laser energy through a special lens that divides the energy into a 9 x 9 (81) matrix of 1 cm square area. The fractional laser rays cause thermal damage that reaches the vaginal sub - epithelium to stimulate the growth of new collagen. Intervention: FemiLift vaginal handpiece is inserted into the vagina, to deliver CO2 laser energy. The vaginal epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length.

Primary Outcome Measures

Name	Time	Method
Success Rate - SUI Symptom Improvement	6 months	Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit

Secondary Outcome Measures

Name	Time	Method
PGI-S	12 months	Change from baseline in Patient Global Impression of Severity (PGI-S) over time
PFIQ	12 months	Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
PISQ	12 months	Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
PFDI	12 months	Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
Urinary Diary	12 months	Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment: * Number of incontinence episodes per day
1 hour pad test	12 months	Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
Vaginal Biopsy	12 months	Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
Safety Endpoint assessed by the rate of serious device related adverse events	12 months	The rate of serious device related adverse events reported during the study