Clinical Consensus Statement: Vaginal Energy-Based Devices.

Area of Science:

• Gynecology
• Urogynecology
• Medical Devices

Background:

• Vaginal energy-based devices (EBDs) are increasingly used for various gynecologic conditions.
• Previous consensus statements from the American Urogynecologic Society (AUGS) addressed EBDs.
• An update was needed to reflect current evidence and clinical practice.

Purpose of the Study:

• To update the clinical consensus on the use of vaginal energy-based devices (EBDs).
• To reassess statements regarding patient and provider criteria, efficacy, safety, and treatment considerations for EBDs.
• To identify areas lacking sufficient evidence for consensus.

Main Methods:

• A modified Delphi process was employed by the AUGS EBD writing group.
• A structured literature search was conducted to evaluate statements.
• Statements were reassessed in March 2022 using interim literature.

Main Results:

• A total of 40 statements were assessed across five categories: patient criteria, provider criteria, efficacy, safety, and treatment considerations.
• Twenty-eight of the 40 statements reached consensus.
• Twelve statements did not reach consensus, primarily due to a lack of supporting evidence for vulvovaginal EBD treatments.

Conclusions:

• The updated consensus provides guidance on the appropriate use of vaginal EBDs.
• Significant gaps in evidence exist for certain applications of vulvovaginal EBDs.
• Further research is needed to establish consensus on EBD treatments where evidence is lacking.