An interventional study of Geneveve Treatment and Sham Treatment in Female Sexual Dysfunction, sponsored by Viveve Inc.. Completed at 21 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Viveve Inc. · Not applicable, Interventional, and Treatment
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.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's enrollment of 250 is above the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →Viveve Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Active Treatment
Device: Geneveve Treatment
Sham Treatment
Device: Sham Treatment
The active treatment group will receive a treatment dose of 90 J/cm\^2
Also known as: Active Treatment
The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm\^2.
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.
Time frame: 6 months post-treatment
Incidence of Treatment-Emergent Adverse Events
Safety as reported through Adverse Events from the time the subject signs the consent form through study completion.
Time frame: 12 months post-treatment
Female Sexual Function Index (FSFI) Arousal Domain Score
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-treatment
Ran from Apr 2018 to primary completion in Mar 2020, 22 months.
Of 112 interventional studies with no phase under Sexual Dysfunction, Physiological, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 22 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sexual Dysfunction, Physiological →
Viveve Inc.