VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

NCT ID: NCT02261974

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-04-30

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.

Detailed Description

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.

Conditions

Vaginal Laxity Following Childbirth; Sexual Function Following Childbirth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Active Treatment Viveve

Intervention Type: DEVICE

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

Group Type: PLACEBO_COMPARATOR

Sham Treatment Viveve

Intervention Type: DEVICE

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

Interventions

Active Treatment Viveve

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

Intervention Type: DEVICE

Sham Treatment Viveve

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to understand and voluntarily sign the informed consent form

2. Pre-menopausal and ≥ 18 years of age

3. At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date

4. Experiences vaginal looseness (laxity) during vaginal intercourse

5. Subject must have a screening blood count and metabolic panel including FSH level of <35 mIU/mL (35 IU/L).

6. Subject must have a normal pelvic exam at baseline and negative chlamydia and gonorrhea cultures during the screening period.

7. Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.

8. Subject must be willing to engage in vaginal intercourse at least once per month.

9. 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.

10. 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

Exclusion Criteria

1. Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.

2. Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment

3. 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

4. Clinically significant pelvic organ prolapse

5. 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

6. Beck Depression Inventory score > 14

7. DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms

8. Taking SSNRI or SSRI drugs

9. Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed

10. Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment

11. History of genital herpes

12. Clinically significant abnormalities in clinical chemistry or hematology at the time of screening

13. 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

14. Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy

15. 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

16. Has undergone the Viveve Procedure previously

17. Has medical condition that in investigator's opinion may interfere with wound healing response

18. Has an acute or a chronic vaginal or vulvar disorder (e.g., vaginal atrophy, pain including vulvodynia, vulvar vestibulitis dysethetic vulvodynia or vulvar dystrophy, current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis lichen planus, tinea cruris, lichen sclerosis, seborrhea dermatitis, contact or irritant dermatitis, lichen simplex, eczema) or bullous dermatoses or systemic diseases with potential involvement of vulva)

19. Has Irritable Bowel Syndrome or Crohn's Disease

20. Has dyspareunia defined as recurrent or persistent painful intercourse that affects sexual activity

21. Has been in another clinical study within four weeks of screening, or is not willing to abstain from enrolling in other clinical studies for duration of trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Viveve Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debbie Wilkerson, PhD

Role: STUDY_DIRECTOR

Viveve Inc.

Locations

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

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

Countries

Canada; Italy; Japan; Spain

Other Identifiers

(OUS) V-013

Identifier Type: -

Identifier Source: org_study_id