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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
3 consecutive sessions of carbon dioxide laser treatment
3 consecutive sessions of sham laser treatment
Rambam health care campus
Haifa, Israel
RECRUITINGVaginal health index
Change in total and specific vaginal health index scores
Time frame: From treatment up to 12 months post treatment
Female sexual function index
Change in total and specific female sexual function index questionnaire scores
Time frame: From treatment up to 12 months post treatment
Sexual intercourse
Change in monthly sexual intercourse rate
Time frame: From treatment up to 12 months post treatment
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