Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.

Study Overview
=================
Brief Summary
-----------------
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed Description
-----------------
Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronic files.

Official Title
-----------------
Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Device: Carbon dioxide laser
* Device: Sham laser treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Negative urine analysis. Normal Pap smear test from the recent 3 years. No previous gynecological laser treatments. Able and willing to comply with the treatment/follow-up schedule and requirements. Exclusion Criteria: Active genital infection. Subject presenting abnormal Pap result from the last three years. Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year). Transvaginal mesh implant. Serious systemic disease or any chronic condition that could interfere with study compliance. Any vaginal bleeding of unknown reason.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser treatment<br>Carbon dioxide laser treatment | Device: Carbon dioxide laser<br>* 3 consecutive sessions of carbon dioxide laser treatment<br>|
| Sham Comparator: Sham treatment<br>Sham laser treatment | Device: Sham laser treatment<br>* 3 consecutive sessions of sham laser treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal health index | Change in total and specific vaginal health index scores | From treatment up to 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female sexual function index | Change in total and specific female sexual function index questionnaire scores | From treatment up to 12 months post treatment | 
| Sexual intercourse | Change in monthly sexual intercourse rate | From treatment up to 12 months post treatment |