N/A N=30 Treatment

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

Vulvovaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT02085980 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: 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 — 27 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Laser treatment (Device)
Age: Adult · 45+ yrs
Sex: Female
Sponsor: El. En. SpA
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	27	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02085980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.