Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy (VIVEVE II)

Viveve

Status: Completed

Conditions: Female Sexual Dysfunction

Treatments: Device: Sham Treatment; Device: Geneveve Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03479229

VIVEVE II (VI-15-01)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Geneveve Treatment

Experimental group

Description:

Active Treatment

Treatment:

Device: Geneveve Treatment

Sham Treatment

Placebo Comparator group

Description:

Sham Treatment

Treatment:

Device: Sham Treatment