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| Name | Class |
|---|---|
| Foundation for Morristown Medical Center | UNKNOWN |
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CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.
The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. To date, there are no effective treatments that address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying cause. This may be more effective than using the topical lidocaine which makes the tissue numb.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 laser | Experimental | Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period. |
|
| Lidocaine | Active Comparator | 5% topical lidocaine will be applied nightly via a cotton square in participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 laser | Device | Mona Lisa CO2 laser |
| |
| Lidocaine patch 5% |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | visual analog pain scale to q-tip palpation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFDI | pelvic floor distress inventory | 3 months |
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Inclusion Criteria:
Age 18 years to 40 years
Hormonal contraceptive therapy for at least one year consecutive duration
Vestibulodynia diagnosis meeting the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden State Urology | Denville | New Jersey | 07834 | United States |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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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| Drug |
lidocaine |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |