Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Viveve Inc.
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- Female Sexual Function Index (FSFI) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age at time of screening and pre-menopausal
- •At least one vaginal delivery (> 37 completed weeks gestation)
- •Sexual dysfunction
- •Negative pregnancy test at Screening visit
- •Sexually active
排除标准
- •Currently breastfeeding or recently discontinued breastfeeding
- •Medical history of keloid formation, genital fistula, thin recto-vaginal septum or obstetric trauma
- •Implantable electrical device
- •Medical or immunological condition
- •Chronic use of anti-inflammatory drugs
- •Current or previous use of local vaginal hormones
- •Undergone previous elective surgical or non-invasive procedure(s) at the vaginal introitus
结局指标
主要结局
Female Sexual Function Index (FSFI) Total Score
时间窗: 6 months post-treatment
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.
次要结局
- Incidence of Treatment-Emergent Adverse Events(12 months post-treatment)
- Female Sexual Function Index (FSFI) Arousal Domain Score(6 months post-treatment)
- Female Sexual Function Index (FSFI) Orgasm Domain Score(6 months post-treatment)
- Female Sexual Function Index (FSFI) Total Score(12 months post-treatment)