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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 AcuPulse Laser treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 AcuPulse Laser | Device | Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in vaginal prolapse symptoms as measured by VHI score at 3 months follow-up visit compared to baseline. | 8 months. |
| Measure | Description | Time Frame |
|---|---|---|
| • Prolapse symptoms improvement as evaluated by the investigator using VHI score at 1 and 6 months follow up visits compared to baseline | 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 |
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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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lior Lowenstein, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| 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 | 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. | 8 months. |
| • Improvement in prolapse grade at 1, 3 and 6 months follow up visits compared to baseline | 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 | 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 | 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. | 8 months. |
| Adverse events (AE's) and serious adverse events (SAE's) | 8 months. |