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

NCT02981654 | Unknown

• 1 other identifier: 2092-15-SMC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Female Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Success Rate - SUI Symptom Improvement

  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

  6 months

Secondary Outcomes (8)

• Urinary Diary

  12 months

• 1 hour pad test

  12 months

• Vaginal Biopsy

  12 months

• PGI-S

  12 months

• PFDI

  12 months

Study Arms (1)

Femilift treatment

EXPERIMENTAL

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epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length.

Device: Alma Lasers Pixel carbon dioxide laser system

Interventions

Alma Lasers Pixel carbon dioxide laser system 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.

Femilift treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• The Baruch Padeh Medical Center, Poriya: collaborator
• Kaplan Medical Center: collaborator

Study Officials

• Menachem Alcalay, MD

  Head, Urogynecology Unit, Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Leopld

CONTACT

972-54-4847271; Yair.Leopold@almasurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: December 5, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share