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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
186
Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus
Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Allan Centre
Calgary, Alberta, Canada
Complexe Medical St-Laurent
Montreal, Quebec, Canada
Les Cours Medical Centre
Montreal, Quebec, Canada
Exogenia Institute of Anti-Aging and Regenerative Medicine
Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score
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.
Time frame: 6 months
Reporting Adverse Events (AEs)
Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.
Time frame: 6 months
Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score
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.
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Sherbrooke, Canada
Research Center of Reproductive Medicine. - IRCCS Policlinico San Matteo Hospital
Pavia, Italy
Yokohama Motomachi Jyosei Iryou Clinic Luna
Kanagawa, Japan
Naoe Beauty Clinic
Tokyo, Japan
Instituto Palacios, Salud de la Mujer
Madrid, Spain
Unidad de Gestión Clínica de Obstetricia y Ginecología. Hospital Universitario Araba
Vitoria-Gasteiz, Spain
Time frame: 6 months
Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)
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.
Time frame: 6 months
Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)
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.
Time frame: 6 months