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

Not Applicable

Completed

• Conditions: Vulvovaginal Atrophy
• Interventions: Device: Laser treatment

• Registration Number: NCT02085980
• Lead Sponsor: El. En. SpA

Brief Summary

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).

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2017-02
• Results First Submitted: 2021-05-11
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-06-04
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser Treatment	Laser treatment	Laser Treatment

Primary Outcome Measures

Name	Time	Method
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	Baseline and at follow up visit at 12 months post last treatment	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).

Trial Locations

Locations (2)

The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital; 🇺🇸 West Chester, Ohio, United States

Stanford University; 🇺🇸 Palo Alto, California, United States