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

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.

Study Overview

• Status: Completed
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Device: Geneveve Treatment; Device: Sham Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 6A5
      • VIVEVE II Study Site
  • New Foundland
    • St. Johns, New Foundland, Canada, A1B 3V6
      • VIVEVE II Study Site
• United States
  • California
    • La Mesa, California, United States, 91942
      • VIVEVE II Study Site
    • Orange, California, United States, 92868
      • VIVEVE II Study Site
  • Colorado
    • Denver, Colorado, United States, 80209
      • VIVEVE II Study Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • VIVEVE II Study Site
  • Florida
    • Lake Worth, Florida, United States, 33461
      • VIVEVE II Study Site
    • Plantation, Florida, United States, 33324
      • VIVEVE II Study Site
    • West Palm Beach, Florida, United States, 33409
      • VIVEVE II Study Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • VIVEVE II Study Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • VIVEVE II Study Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • VIVEVE II Study Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • VIVEVE II Study Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • VIVEVE II Study Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • VIVEVE II Study Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • VIVEVE II Study Site
  • New York
    • New York, New York, United States, 10038
      • VIVEVE II Study Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • VIVEVE II Study Site
  • Ohio
    • Columbus, Ohio, United States, 43221
      • VIVEVE II Study Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • VIVEVE II Study Site
  • Washington
    • Tacoma, Washington, United States, 98042
      • VIVEVE II Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Geneveve Treatment; Active Treatment	Device: Geneveve Treatment; The active treatment group will receive a treatment dose of 90 J/cm^2; Other Names: Active Treatment
Placebo Comparator: Sham Treatment	Device: Sham Treatment; The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Viveve Inc.
• Investigators: Study Director: Stacie Bell, PhD, Viveve Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: satisfaction; sexual dysfunction; sexual function; arousal; lubrication; orgasm; desire; vaginal laxity; vaginal childbirth; diminished sexual function
• Other Study ID Numbers: VIVEVE II (VI-15-01)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes