Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy

Female Sexual Dysfunction Clinical Trial

— VIVEVE II  

Official title:

Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479229
• Other study ID #: VIVEVE II (VI-15-01)
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2020
• Source: Viveve Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Device:
• Geneveve Treatment
The active treatment group will receive a treatment dose of 90 J/cm^2
• Sham Treatment
The sham group will receive a sub-therapeutic dose of = 1 J/cm^2.

Locations

Country	Name	City	State
Canada	VIVEVE II Study Site	Calgary	Alberta
Canada	VIVEVE II Study Site	St. Johns	New Foundland
United States	VIVEVE II Study Site	Albuquerque	New Mexico
United States	VIVEVE II Study Site	Atlanta	Georgia
United States	VIVEVE II Study Site	Columbus	Ohio
United States	VIVEVE II Study Site	Denver	Colorado
United States	VIVEVE II Study Site	Idaho Falls	Idaho
United States	VIVEVE II Study Site	Jackson	Tennessee
United States	VIVEVE II Study Site	Kalamazoo	Michigan
United States	VIVEVE II Study Site	La Mesa	California
United States	VIVEVE II Study Site	Lake Worth	Florida
United States	VIVEVE II Study Site	New Brunswick	New Jersey
United States	VIVEVE II Study Site	New York	New York
United States	VIVEVE II Study Site	Omaha	Nebraska
United States	VIVEVE II Study Site	Orange	California
United States	VIVEVE II Study Site	Plantation	Florida
United States	VIVEVE II Study Site	Raleigh	North Carolina
United States	VIVEVE II Study Site	Saint Louis	Missouri
United States	VIVEVE II Study Site	Tacoma	Washington
United States	VIVEVE II Study Site	Washington	District of Columbia
United States	VIVEVE II Study Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Viveve Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	6 months post-treatment
Secondary	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
Secondary	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