Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Device: Laser treatment

Detailed Description

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Stanford University
  • Ohio
    • West Chester, Ohio, United States, 45069
      • The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
• Exhibiting VVA symptoms
• Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
• Have not had procedures in the anatomical area through 6 months prior to treatment
• Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria:

• • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).

  • Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
  • Any serious disease, or chronic condition, that could interfere with the study compliance
  • Previously undergone reconstructive pelvic surgery
  • Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  • Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  • Taking medications that are photosensitive
  • A history of keloid formation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Treatment	Device: Laser treatment; The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline	The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).	Baseline and at follow up visit at 12 months post last treatment

Collaborators and Investigators

• Sponsor: El. En. SpA
• Collaborators: Stanford University; The Christ Hospital
• Investigators: Principal Investigator: Mickey Karram, MK, Hospital Physician, The Christ Hospital; Study Director: Eric Sokol, MD, Stanford University

Publications and helpful links

General Publications

• van der Laak JA, de Bie LM, de Leeuw H, de Wilde PC, Hanselaar AG. The effect of Replens on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry. J Clin Pathol. 2002 Jun;55(6):446-51. doi: 10.1136/jcp.55.6.446.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: ELEN13-VVA-MK01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO