VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness (VIVEVE I)
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|ClinicalTrials.gov Identifier: NCT02261974|
Recruitment Status : Completed
First Posted : October 10, 2014
Results First Posted : December 27, 2017
Last Update Posted : August 28, 2018
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design
The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Laxity Following Childbirth Sexual Function Following Childbirth||Device: Active Treatment Viveve Device: Sham Treatment Viveve||Not Applicable|
A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is planned. This study is designed to demonstrate that the active treatment (i.e., Viveve Procedure) is superior to the sham treatment for the primary effectiveness and safety endpoints.
Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active treatment group or sham group. The active treatment group will receive a treatment dose of 90 J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.
Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post treatment.
Final data will be reported at 6 months for active and sham treatments.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: 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
Device: Active Treatment Viveve
Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus
Placebo Comparator: 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
Device: 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 [ Time Frame: 6 months ]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.
- Reporting Adverse Events (AEs) [ Time Frame: 6 months ]Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.
- Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score [ Time Frame: 6 months ]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.
- Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ) [ Time Frame: 6 months ]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.
- Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R) [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261974
|Calgary, Alberta, Canada, AB T2 7G9|
|Complexe Medical St-Laurent|
|Montreal, Quebec, Canada, H4R 0B7|
|Les Cours Medical Centre|
|Montreal, Quebec, Canada, QC H3 A1 T5|
|Exogenia Institute of Anti-Aging and Regenerative Medicine|
|Research Center of Reproductive Medicine. - IRCCS Policlinico San Matteo Hospital|
|Yokohama Motomachi Jyosei Iryou Clinic Luna|
|Naoe Beauty Clinic|
|Instituto Palacios, Salud de la Mujer|
|Unidad de Gestión Clínica de Obstetricia y Ginecología. Hospital Universitario Araba|
|Study Director:||Debbie Wilkerson, PhD||Viveve Inc.|