Evaluation of Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Vaginal Elasticity.

Rambam Health Care Campus

Status: Completed

Conditions: Exposure Laser

Treatments: Device: CO2 AcuPulse Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02847897

0217-16-RMB

Details and patient eligibility

About

The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with vaginal prolapse. Eligible subjects will receive 3 treatment sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Full description

Following a screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronical files.

Enrollment: 33 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy post-menopausal women as defined by one of the following: A. ≥ 40 years old, last spontaneous menstrual bleeding occurred at least ≥ 12 months prior to screening B. ≥ 45 years old, does not remember the date of last spontaneous menstrual bleeding and provides lab results showing that the follicle-stimulating hormone (FSH) level is > 40 IU/L C. Underwent a hysterectomy without oophorectomy and provides lab results showing that serum FSH levels > 40IU/L D. Underwent bilateral oophorectomy at least 12 weeks prior to screening

• Presence of one or more of the prolapse related symptoms (e.g. dryness, itching, burning, dysuria or dyspareunia)
• At least 10 subjects of the sample will have symptoms of urinary stress incontinence (Stamey classification Grade =1)
• Negative urine analysis
• Normal Papanicolaou (PAP) test from the recent year
• Sexually active (having sex at least once a month) or wishing to maintain an active sexual life
• Able and willing to comply with the treatment/follow-up schedule and requirements

Exclusion criteria

• Vaginal Health Index Score (VHIS) < 5
• Active genital infection
• Subject presenting abnormal PAP result from the last three years with any of the following findings according to the Bethesda System (2001) classification:

A. Atypical Squamous Cells of Undetermined Significance (ASCUS with positive human papilloma virus (HPV) High Risk Positive B. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion C. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) D. Low Grade squamous intraepithelial lesion (LSIL) E. High Grade squamous intraepithelial lesion (HSIL) F. Carcinoma

• Systemic steroids use within the last 3 months
• Systemic hormonal replacement therapies within the last 3 months
• Local hormonal replacement therapies within last month
• Vaginal lubricants within 7 days prior to enrollment
• Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year)
• Pelvic organ prolapse (POP) >II according to the pelvic organ prolapse quantification system
• Transvaginal mesh implant
• Serious systemic disease or any chronic condition that could interfere with study compliance
• Taken part in a clinical trial within 30 days prior to screening.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

CO2 AcuPulse Laser treatment

Experimental group

Description:

Subjects with vulvovaginal atrophy intended to receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.

Treatment:

Device: CO2 AcuPulse Laser