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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
Rambam health care campus
Haifa, Israel
The change in vaginal prolapse symptoms as measured by VHI score at 3 months follow-up visit compared to baseline.
Time frame: 8 months.
• Prolapse symptoms improvement as evaluated by the investigator using VHI score at 1 and 6 months follow up visits compared to baseline
Time frame: 8 months.
• Prolapse symptoms improvement as evaluated by the subject using Visual Analogue Scale (VAS) at 1, 3 and 6 months follow up visits compared to baseline
Time frame: 8 months.
• Improvement in sexual function as evaluated by the subject Female Sexual Function Index (FSFI) at 1, 3 and 6 months follow up visits compared to baseline
Time frame: 8 months.
• Improvement in urinary incontinence as evaluated by subject Incontinence Quality of Life Questionnaire (I-QOL) at 1, 3 and 6 months follow up visits compared to baseline.
Time frame: 8 months.
• Improvement in prolapse grade at 1, 3 and 6 months follow up visits compared to baseline
Time frame: 8 months.
• Subject satisfaction with the treatment sing a 5-point Likert scale at baseline and at 1, 3 and 6 months follow up visits
Time frame: 8 months.
• Subject self- assessment of downtime related to procedure - the period of time following the procedure during which the subject felt uncomfortable/unwilling or unable to have sexual intercourse
Time frame: 8 months.
• Subject assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (VAS), evaluated at each treatment.
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Time frame: 8 months.
Adverse events (AE's) and serious adverse events (SAE's)
Time frame: 8 months.