Clinical trial NCT03479229: Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
Official title: Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: vaginal laxity
sexual function
vaginal childbirth
sexual dysfunction
diminished sexual function
satisfaction
arousal
desire
lubrication
orgasm
Lead sponsor: Viveve Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Female Sexual Function Index (FSFI) Total Score
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 months post-treatment
measure: Female Sexual Function Index (FSFI) Arousal Domain Score
timeFrame: 6 months post-treatment
measure: Female Sexual Function Index (FSFI) Orgasm Domain Score
timeFrame: 6 months post-treatment
measure: Female Sexual Function Index (FSFI) Total Score
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: VIVEVE II Study Site
state: California
city: Orange
country: United States
facility: VIVEVE II Study Site
state: California
city: Denver
country: United States
facility: VIVEVE II Study Site
state: Colorado
city: Washington
country: United States
facility: VIVEVE II Study Site
state: District of Columbia
city: Lake Worth
country: United States
facility: VIVEVE II Study Site
state: Florida
city: Plantation
country: United States
facility: VIVEVE II Study Site
state: Florida
city: West Palm Beach
country: United States
facility: VIVEVE II Study Site
state: Florida
city: Atlanta
country: United States
facility: VIVEVE II Study Site
state: Georgia
city: Idaho Falls
country: United States
facility: VIVEVE II Study Site
state: Idaho
city: Kalamazoo
country: United States
facility: VIVEVE II Study Site
state: Michigan
city: Saint Louis
country: United States
facility: VIVEVE II Study Site
state: Missouri
city: Omaha
country: United States
facility: VIVEVE II Study Site
state: Nebraska
city: New Brunswick
country: United States
facility: VIVEVE II Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: VIVEVE II Study Site
state: New Mexico
city: New York
country: United States
facility: VIVEVE II Study Site
state: New York
city: Raleigh
country: United States
facility: VIVEVE II Study Site
state: North Carolina
city: Columbus
country: United States
facility: VIVEVE II Study Site
state: Ohio
city: Jackson
country: United States
facility: VIVEVE II Study Site
state: Tennessee
city: Tacoma
country: United States
facility: VIVEVE II Study Site
state: Washington
city: Calgary
country: Canada
facility: VIVEVE II Study Site
state: Alberta
city: St. Johns
country: Canada
facility: VIVEVE II Study Site
state: New Foundland
Study officials:
affiliation: Viveve Inc.
name: Stacie Bell, PhD
role: STUDY_DIRECTOR
References: