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

Sponsor

Viveve Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03479229

Collaborator

(none)

250

Enrollment

Locations

Arms

22.8

Actual Duration (Months)

11.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Sexual Dysfunction	Device: Geneveve Treatment Device: Sham Treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 20, 2018

Actual Primary Completion Date :

Mar 15, 2020

Actual Study Completion Date :

Mar 15, 2020

Arms and Interventions

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 Sham Treatment	Device: Sham Treatment The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2.

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

Sham Treatment

Device: Sham Treatment

The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2.

Outcome Measures

Primary Outcome Measures

Female Sexual Function Index (FSFI) Total Score [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.

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [12 months post-treatment]
Safety as reported through Adverse Events from the time the subject signs the consent form through study completion.
Female Sexual Function Index (FSFI) Arousal Domain Score [6 months post-treatment]
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.
Female Sexual Function Index (FSFI) Orgasm Domain Score [6 months post-treatment]
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.
Female Sexual Function Index (FSFI) Total Score [12 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIVEVE II Study Site	La Mesa	California	United States	91942
2	VIVEVE II Study Site	Orange	California	United States	92868
3	VIVEVE II Study Site	Denver	Colorado	United States	80209
4	VIVEVE II Study Site	Washington	District of Columbia	United States	20036
5	VIVEVE II Study Site	Lake Worth	Florida	United States	33461
6	VIVEVE II Study Site	Plantation	Florida	United States	33324
7	VIVEVE II Study Site	West Palm Beach	Florida	United States	33409
8	VIVEVE II Study Site	Atlanta	Georgia	United States	30342
9	VIVEVE II Study Site	Idaho Falls	Idaho	United States	83404
10	VIVEVE II Study Site	Kalamazoo	Michigan	United States	49009
11	VIVEVE II Study Site	Saint Louis	Missouri	United States	63117
12	VIVEVE II Study Site	Omaha	Nebraska	United States	68114
13	VIVEVE II Study Site	New Brunswick	New Jersey	United States	08901
14	VIVEVE II Study Site	Albuquerque	New Mexico	United States	87131
15	VIVEVE II Study Site	New York	New York	United States	10038
16	VIVEVE II Study Site	Raleigh	North Carolina	United States	27612
17	VIVEVE II Study Site	Columbus	Ohio	United States	43221
18	VIVEVE II Study Site	Jackson	Tennessee	United States	38305
19	VIVEVE II Study Site	Tacoma	Washington	United States	98042
20	VIVEVE II Study Site	Calgary	Alberta	Canada	T2J 6A5
21	VIVEVE II Study Site	St. Johns	New Foundland	Canada	A1B 3V6