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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatment | Active Comparator | Carbon dioxide laser treatment |
|
| Sham treatment | Sham Comparator | Sham laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon dioxide laser | Device | 3 consecutive sessions of carbon dioxide laser treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal health index | Change in total and specific vaginal health index scores | From treatment up to 12 months post treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roy Lauterbach, MD | Contact | +972-52-9432416 | r_lauterbach@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam healthcare campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Recruiting | Haifa | Israel |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Sham laser treatment |
| Device |
3 consecutive sessions of sham laser treatment |
|
| From treatment up to 12 months post treatment |