Trial Outcomes & Findings for VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness (NCT NCT02261974)

NCT ID: NCT02261974

Last Updated: 2018-08-28

Results Overview

The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. 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 (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

186 participants

Primary outcome timeframe

6 months

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Active Viveve Treatment Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Overall Study STARTED	123	63
Overall Study Treated	117	57
Overall Study COMPLETED	108	56
Overall Study NOT COMPLETED	15	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Viveve Treatment Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Overall Study Withdrawal by Subject	3	2
Overall Study Pregnancy	0	1
Overall Study Missed treatment cut-off date	6	3
Overall Study Received partial treatment; FU to 1 mo	3	1
Overall Study Lost to Follow-up	2	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Viveve Treatment n=123 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=63 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus	Total n=186 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 6.0 • n=123 Participants	41.1 years STANDARD_DEVIATION 5.6 • n=63 Participants	40.8 years STANDARD_DEVIATION 5.9 • n=186 Participants
Sex: Female, Male Female	123 Participants n=123 Participants	63 Participants n=63 Participants	186 Participants n=186 Participants
Sex: Female, Male Male	0 Participants n=123 Participants	0 Participants n=63 Participants	0 Participants n=186 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	24.6 kg/m^2 STANDARD_DEVIATION 4.6 • n=123 Participants	24.4 kg/m^2 STANDARD_DEVIATION 5.4 • n=63 Participants	24.5 kg/m^2 STANDARD_DEVIATION 4.8 • n=186 Participants
Comorbidities Hypertension	7 Participants n=123 Participants	2 Participants n=63 Participants	9 Participants n=186 Participants
Comorbidities Ear, nose, or throat condition	6 Participants n=123 Participants	7 Participants n=63 Participants	13 Participants n=186 Participants
Comorbidities Dermatologic condition	9 Participants n=123 Participants	4 Participants n=63 Participants	13 Participants n=186 Participants
Comorbidities Pulmonary condition	2 Participants n=123 Participants	4 Participants n=63 Participants	6 Participants n=186 Participants
Comorbidities Hepatic or biliary condition	3 Participants n=123 Participants	4 Participants n=63 Participants	7 Participants n=186 Participants
Comorbidities Endocrine condition	12 Participants n=123 Participants	5 Participants n=63 Participants	17 Participants n=186 Participants
Comorbidities Neurologic condition	10 Participants n=123 Participants	3 Participants n=63 Participants	13 Participants n=186 Participants
Comorbidities Psychiatric condition	3 Participants n=123 Participants	3 Participants n=63 Participants	6 Participants n=186 Participants
Comorbidities Hematologic condition	8 Participants n=123 Participants	5 Participants n=63 Participants	13 Participants n=186 Participants
Comorbidities Allergies	20 Participants n=123 Participants	13 Participants n=63 Participants	33 Participants n=186 Participants
Comorbidities Gynecologic condition	19 Participants n=123 Participants	7 Participants n=63 Participants	26 Participants n=186 Participants
Comorbidities Prior Surgeries	82 Participants n=123 Participants	41 Participants n=63 Participants	123 Participants n=186 Participants
Comorbidities Prior STD	7 Participants n=123 Participants	2 Participants n=63 Participants	9 Participants n=186 Participants
Gravidity Per Subject	2.7 Pregnancies STANDARD_DEVIATION 1.4 • n=123 Participants	2.7 Pregnancies STANDARD_DEVIATION 1.3 • n=63 Participants	2.7 Pregnancies STANDARD_DEVIATION 1.4 • n=186 Participants
Time Since Last Delivery	8.0 years STANDARD_DEVIATION 6.3 • n=123 Participants	8 years STANDARD_DEVIATION 5.5 • n=63 Participants	8 years STANDARD_DEVIATION 6 • n=186 Participants
Median Birth weight	3.3 kg STANDARD_DEVIATION .7 • n=123 Participants	3.4 kg STANDARD_DEVIATION .5 • n=63 Participants	3.3 kg STANDARD_DEVIATION .6 • n=186 Participants
Number of Vaginal Deliveries per Subject	2.1 Number of Reported Vaginal Deliveries STANDARD_DEVIATION 1 • n=123 Participants	2 Number of Reported Vaginal Deliveries STANDARD_DEVIATION .9 • n=63 Participants	2.1 Number of Reported Vaginal Deliveries STANDARD_DEVIATION .9 • n=186 Participants

PRIMARY outcome

Timeframe: 6 months

Population: This population consists of all randomized subjects who completed the six month assessment.

Outcome measures

Outcome measures
Measure	Active Viveve Treatment n=108 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=55 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score	4.16 Units on a Scale Standard Error 0.48	2.36 Units on a Scale Standard Error 0.67

PRIMARY outcome

Timeframe: 6 months

Population: Table includes treatment-emergent adverse events (AEs), defined as AEs that began or worsened in severity after treatment. This population consists of all subjects who were randomized and who received a complete or partial treatment.

Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.

Outcome measures

Outcome measures
Measure	Active Viveve Treatment n=117 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=57 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Reporting Adverse Events (AEs)	13 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months

Population: This population consists of all randomized subjects with a 6 month assessment.

Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity ("looseness") and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.

Outcome measures

Outcome measures
Measure	Active Viveve Treatment n=107 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=56 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score	7.28 Units on a Scale Standard Error 0.64	6.32 Units on a Scale Standard Error 0.89

SECONDARY outcome

Timeframe: 6 months

Population: This population consists of all randomized subjects who completed a 6 month assessment.

Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = "Very Loose" and 7 = "Very Tight". The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.

Outcome measures

Outcome measures
Measure	Active Viveve Treatment n=108 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=56 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)	1.81 Units on a Scale Standard Error 0.15	1.07 Units on a Scale Standard Error .21

SECONDARY outcome

Timeframe: 6 months

Population: This population consists of all randomized subjects who completed a 6 month assessment.

The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a "worse outcome". The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening.

Outcome measures

Outcome measures
Measure	Active Viveve Treatment n=107 Participants Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=56 Participants Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)	-6.55 Units on a Scale Standard Error 0.74	-4.13 Units on a Scale Standard Error 1.02

Adverse Events

Active Viveve Treatment

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Sham Viveve Treatment

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Viveve Treatment n=117 participants at risk Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus Active Treatment Viveve: Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus	Sham Viveve Treatment n=57 participants at risk Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus Sham Treatment Viveve: Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Infections and infestations Kidney Infection	0.00% 0/117 • 6 months post-treatment The definitions of adverse event (AE) and serious adverse event (SAE) used in this study were consistent with the clinicaltrials.gov definitions. Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3, which stratifies severity across five (5) levels rather than the three (3) used in the clinicaltrials.gov definitions.	1.8% 1/57 • 6 months post-treatment The definitions of adverse event (AE) and serious adverse event (SAE) used in this study were consistent with the clinicaltrials.gov definitions. Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3, which stratifies severity across five (5) levels rather than the three (3) used in the clinicaltrials.gov definitions.

Other adverse events

Additional Information

Debbie Wilkerson, PhD, Vice President, Clinical and Medical Affairs

Viveve, Inc.

Phone: 610-209-9980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place