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

NCT ID: NCT02981654

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-05-31

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

Conditions

Female Stress Urinary Incontinence

Study Design

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

Study Groups

Femilift treatment

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.

Group Type: EXPERIMENTAL

Alma Lasers Pixel carbon dioxide laser system

Intervention Type: DEVICE

The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.

Interventions

Alma Lasers Pixel carbon dioxide laser system

The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role: collaborator

Kaplan Medical Center

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Menachem Alcalay, MD

Role: PRINCIPAL_INVESTIGATOR

Head, Urogynecology Unit, Chaim Sheba Medical Center

Central Contacts

Yair Leopld

Role: CONTACT

Phone: 972-54-4847271

Email: Yair.Leopold@almasurgical.com

Other Identifiers

2092-15-SMC

Identifier Type: -

Identifier Source: org_study_id