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This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months.
Decreased sensation and decreased sexual satisfaction following vaginal childbirth has the potential to negatively impact overall sexual function and quality of life in many women. Previous research by obstetricians and gynecologists (OB/GYNs) found that changes in sexual health post-childbirth are not often discussed between physicians and their patients. One possible reason these discussions are not being initiated by physicians is the lack of an evidence-based treatment other than surgery.
While traditional surgery can be performed to improve sexual function following childbirth, pain at incision lines and scarring can lead to dyspareunia for months following the procedure, and a surgical procedure can be painful and the sutures may cause dense scarring. The post-operative recovery may last up to seven days before a woman can return to work. Resuming intercourse is not recommended for at least six weeks after these invasive surgeries. For the many women who are not good surgical candidates, due to health issues or situational limitations on downtime or their unwillingness to undergo a surgical procedure to improve sexual function, there is no other option.
The Geneveve Treatment offers a simple alternative to traditional surgery using non-ablative radiofrequency (RF) energy as a non-surgical approach to improve sexual function following vaginal childbirth. It induces a mild, controlled reaction in the submucosal tissues that stimulates the body to deposit collagen, thereby remodeling the tissue without causing scarring.
This study is designed to demonstrate that active treatment (i.e., Geneveve Treatment) is superior to the sham treatment for the primary efficacy and safety endpoints.
The active treatment group will receive a treatment dose of 90 J/cm^2 and the sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2. The participant, the investigator, and all study personnel will be blinded to the assignment for the entire study duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geneveve Treatment | Experimental | Active Treatment |
|
| Sham Treatment | Placebo Comparator | Sham Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geneveve Treatment | Device | The active treatment group will receive a treatment dose of 90 J/cm^2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index (FSFI) Total Score | The FSFI is a 19-item validated measure of female sexual function. The FSFI consists of six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. The six domain scores are summed to obtain the full scale score. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. The total score is the sum of the domain scores and ranges from 2-36. | 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Safety as reported through Adverse Events from the time the subject signs the consent form through study completion. | 12 months post-treatment |
| Female Sexual Function Index (FSFI) Arousal Domain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie Bell, PhD | Viveve Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIVEVE II Study Site | La Mesa | California | 91942 | United States | ||
| VIVEVE II Study Site |
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| Sham Treatment | Device | The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2. |
|
The FSFI is a 19-item validated measure of female sexual function. The FSFI Arousal domain recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month.
| 6 months post-treatment |
| Female Sexual Function Index (FSFI) Orgasm Domain Score | The FSFI is a 19-item validated measure of female sexual function. The FSFI Orgasm domain recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. | 6 months post-treatment |
| Female Sexual Function Index (FSFI) Total Score | The FSFI is a 19-item validated measure of female sexual function. The FSFI consists of six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. The six domain scores are summed to obtain the full scale score. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. The total score is the sum of the domain scores and ranges from 2-36. | 12 months post-treatment |
| Orange |
| California |
| 92868 |
| United States |
| VIVEVE II Study Site | Denver | Colorado | 80209 | United States |
| VIVEVE II Study Site | Washington D.C. | District of Columbia | 20036 | United States |
| VIVEVE II Study Site | Lake Worth | Florida | 33461 | United States |
| VIVEVE II Study Site | Plantation | Florida | 33324 | United States |
| VIVEVE II Study Site | West Palm Beach | Florida | 33409 | United States |
| VIVEVE II Study Site | Atlanta | Georgia | 30342 | United States |
| VIVEVE II Study Site | Idaho Falls | Idaho | 83404 | United States |
| VIVEVE II Study Site | Kalamazoo | Michigan | 49009 | United States |
| VIVEVE II Study Site | St Louis | Missouri | 63117 | United States |
| VIVEVE II Study Site | Omaha | Nebraska | 68114 | United States |
| VIVEVE II Study Site | New Brunswick | New Jersey | 08901 | United States |
| VIVEVE II Study Site | Albuquerque | New Mexico | 87131 | United States |
| VIVEVE II Study Site | New York | New York | 10038 | United States |
| VIVEVE II Study Site | Raleigh | North Carolina | 27612 | United States |
| VIVEVE II Study Site | Columbus | Ohio | 43221 | United States |
| VIVEVE II Study Site | Jackson | Tennessee | 38305 | United States |
| VIVEVE II Study Site | Tacoma | Washington | 98042 | United States |
| VIVEVE II Study Site | Calgary | Alberta | T2J 6A5 | Canada |
| VIVEVE II Study Site | St. Johns | New Foundland | A1B 3V6 | Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2022 | Jul 6, 2022 | 5 |
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D010549 | Personal Satisfaction |
| D009948 | Orgasm |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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