Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence. (CO2)
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|ClinicalTrials.gov Identifier: NCT02981654|
Recruitment Status : Unknown
Verified December 2016 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Female Stress Urinary Incontinence||Device: Alma Lasers Pixel carbon dioxide laser system||Not Applicable|
Improvement in SUI symptoms as measured by the following 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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2018|
Experimental: 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.
Device: 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.
- Success Rate - SUI Symptom Improvement [ Time Frame: 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
- Urinary Diary [ Time Frame: 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 [ Time Frame: 12 months ]Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
- Vaginal Biopsy [ Time Frame: 12 months ]Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
- PGI-S [ Time Frame: 12 months ]Change from baseline in Patient Global Impression of Severity (PGI-S) over time
- PFDI [ Time Frame: 12 months ]Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
- PISQ [ Time Frame: 12 months ]Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
- PFIQ [ Time Frame: 12 months ]Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
- Safety Endpoint assessed by the rate of serious device related adverse events [ Time Frame: 12 months ]The rate of serious device related adverse events reported during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981654
|Contact: Yair Leopld||972-54-4847271||Yair.Leopold@almasurgical.com|
|Principal Investigator:||Menachem Alcalay, MD||Head, Urogynecology Unit, Chaim Sheba Medical Center|