VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

NCT02261974 | Completed Results FDA Device

• 1 other identifier: (OUS) V-013
• Study Type: interventional
• Target: 186
• Locations: 4 countries
• Sites: 9

Brief Summary

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.

Conditions

Vaginal Laxity Following Childbirth; Sexual Function Following Childbirth

Keywords

Vaginal laxity; Sexual Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (3)

• Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score

  6 months

• Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)

  6 months

• Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)

  6 months

Study Arms (2)

Active Viveve Treatment

ACTIVE COMPARATOR

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

Sham Viveve Treatment

PLACEBO COMPARATOR

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

Interventions

Active Treatment Viveve DEVICE

Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus

Active Viveve Treatment

Sham Treatment Viveve DEVICE

Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus

Sham Viveve Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign the informed consent form
• Pre-menopausal and ≥ 18 years of age
• At least one full term vaginal delivery (\> 37 completed weeks gestation) at least 12 months prior to enrollment date
• Experiences vaginal looseness (laxity) during vaginal intercourse
• Subject must have a screening blood count and metabolic panel including FSH level of \<35 mIU/mL (35 IU/L).
• Subject must have a normal pelvic exam at baseline and negative chlamydia and gonorrhea cultures during the screening period.
• Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.
• Subject must be willing to engage in vaginal intercourse at least once per month.
• Subject must be in a monogamous, heterosexual relationship for at least six months prior to screening visit with a partner who is sexually functional and available at least 50% of the time.
• Subject is surgically sterilized, or is willing to use an acceptable method of birth control that was begun at least 3 month prior to screening and to be continued or throughout the duration of the study \[i.e., barrier method (e.g., diaphragm), hormonal therapy (subcutaneous, injectable, or oral contraceptive) intrauterine device\], or partner is surgically sterilized

You may not qualify if:

• Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.
• Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment
• History of a genital fistula, a thin recto-vaginal septum as determined by the investigator, or history of a fourth degree laceration during screening physical exam
• Clinically significant pelvic organ prolapse
• Currently meets the criteria for a female sexual disorder, including DSM V, FSAD, FOD, Genitopelvic Pain, Sexual Aversion, Dyspareunia, or Vaginismus, and has not been treated for this condition within the past 12 months
• Beck Depression Inventory score \> 14
• DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms
• Taking SSNRI or SSRI drugs
• Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed
• Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment
• History of genital herpes
• Clinically significant abnormalities in clinical chemistry or hematology at the time of screening
• Currently taking prescribed medications, OTC products or supplements that may impact or enhance sexual function (e.g., antihypertensive, psychotropic, chemotherapeutic agent, PD5 Inhibitors) as assessed by the investigator
• Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy
• Has an implantable pacemaker, an automatic implantable cardioverter/defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency fields or current

Sponsors & Collaborators

• Viveve Inc.: lead

Study Sites (9)

Allan Centre

Calgary, Alberta, AB T2 7G9, Canada

Location

Complexe Medical St-Laurent

Montreal, Quebec, H4R 0B7, Canada

Location

Les Cours Medical Centre

Montreal, Quebec, QC H3 A1 T5, Canada

Location

Exogenia Institute of Anti-Aging and Regenerative Medicine

Sherbrooke, Canada

Location

Research Center of Reproductive Medicine. - IRCCS Policlinico San Matteo Hospital

Pavia, Italy

Location

Yokohama Motomachi Jyosei Iryou Clinic Luna

Kanagawa, Japan

Location

Naoe Beauty Clinic

Tokyo, Japan

Location

Instituto Palacios, Salud de la Mujer

Madrid, Spain

Location

Unidad de Gestión Clínica de Obstetricia y Ginecología. Hospital Universitario Araba

Vitoria-Gasteiz, Spain

Location

Results Point of Contact

• Title: Debbie Wilkerson, PhD, Vice President, Clinical and Medical Affairs
• Organization: Viveve, Inc.

dwilkerson@viveve.com

610-209-9980

Study Officials

• Debbie Wilkerson, PhD

  Viveve Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 10, 2014
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 28, 2018
• Results First Posted: December 27, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CA (4); JP (2); ES (2)