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Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment.
Total expected study duration is approximately 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | 3 treatments once a month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MorpheusV Applicator | Device | Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| effect of treatment on VVA symptoms, | effect of treatment on VVA symptoms, such as pain, vaginal burning, vaginal itching, dyspareunia and dysuria, using the Visual Analog Scale (VAS). scored from 1 to 10, the lower the score the better the outcome | baseline through 12 months |
| objective evaluation of vaginal atrophy/estrogenization | measured by the globally validated "Vaginal Health Index" (VHI) score at follow up visits 3M, 6M FU and 12M FU) compared to Baseline. Scored from 5 to 25, the higher the score the better the outcome | baseline through 12 months |
| Assess the effect of treatment on the general quality of life, | by mean of the "Short Form 12" (SF-12) specific questionnaire. Administered at baseline and at follow up visits 3M, 6M and 12M FU). | baseline through 12 months |
| The effect of the treatment on Sexual Function | measured by Female Sexual Function Index (FSFI) at follow up visits (3M FU,6M FU and 12M FU) compared to baseline. the higher the score the better the outcome | baseline through 12 months |
| Assess the degree of difficulty encountered by the physician in performing the treatment, | by mean of a 5-point Likert scale. the higher the score the better the outcome | baseline through 12 months |
| The rate of satisfaction of patients with treatment | assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale. The subjects will answer this questionnaire at follow up visits 3M FU, 6M and 12M FU). the higher the score the better the outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of expected post-treatment adverse events | Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale | up to 12 months |
| Discomfort scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beyond Regenerative Medicine and Aesthetics | Newport Beach | California | 92660 | United States | ||
| Institute for Female Pelvic Medicine |
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| baseline through 12 months |
| The effect of the treatment on urinary symptoms | by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at each follow up visit (3M FU, 6M FU, 12M FU). the lower the score the better the outcome | baseline through 12 months |
A 10cm visual analog scale from 0 (no discomfort) to 10 (worst possible discomfort) to measure discomfort associated with probe insertion, and RF energy application at the treatment visit
| up to 3 months |
| Adverse events | Number, severity and type of any adverse event recorded throughout the course of the study. | baseline through 12 months |
| Knoxville |
| Tennessee |
| 37932 |
| United States |