Evidence map›Paper›PMID 30830556›Full record

ArticleLasers in medical science2019

In response to the FDA warning about the use of photomedicine in gynecology.

Juan José Escribano, Pablo González-Isaza, Konstantinos Tserotas, Stavros Athanasiou, Nicola Zerbinati, Gustavo Leibaschoff, Stefano Salvatore, Rafael Sánchez-Borrego

Registry-linked trialAbstract readLetter
PubMed Publisher
In one paragraph

Article in Lasers in medical science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05585476 (Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05585476 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.

TypeinterventionalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2025 to 2026Enrolled180ConditionsFemale Urogenital Diseases, Breast Cancer FemaleArmsC02 microablative laser, Regenerative topical treatment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. COInternational urogynecology journal · 2022
    Trial
  2. Trial
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Juan José EscribanoUnidad Ginecoestetica, Instituto Médico Laser, Madrid, Spain.
Pablo González-IsazaDivisión de Uroginecología y Cirugía Mínimamente Invasiva, Liga contra el Cáncer, Hospital Universitario San Jorge, Pereira, Colombia.
Konstantinos TserotasClinica de GinecoEndocrino, Complejo Hospitalario Metropolitano Caja Seguro Social, Panamá, Panama.
Stavros AthanasiouUrogynaecology Unit, 1st Department of Obstetrics and Gynecology, "Alexandra" Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Nicola ZerbinatiDepartment of Dermatology, School of Medicine, University of Insubria, Varese, Italy.
Gustavo LeibaschoffCosmetic Gynecology, General Secretary of the World Society of Cosmetic Gynecology, Dallas, TX, USA.
Stefano SalvatoreObstetrics and Gynecology Unit, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, Milan, Italy.
Rafael Sánchez-BorregoDIATROS, Clínica de Atención a la Mujer, C/ Aragó 403-405, 08013, Barcelona, Spain. rschez.borrego@diatros.com.ORCID http://orcid.org/0000-0001-6583-7440

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To alert patients and health care providers about the use of energy-based devices to perform a vaginal "rejuvenation," cosmetic vaginal procedures, or nonsurgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function, the US Food and Drug Administration (FDA) has issued a warning about the effectiveness and safety of such devices. We agree with the FDA that certain devices (laser, radiofrequency, etc.) have been marketed inappropriately for uses that are outside of their cleared or approved intended uses. We want to position ourselves in the strict training of professionals so that the indications and techniques are used in the best possible way, knowing that, similar to any medical or surgical technique, the side effects can appear in the short and long term, and should be recognized and remedied.

Indexed as

GynecologyPhototherapyUnited States Food and Drug AdministrationHumansLaser TherapyPractice Guidelines as TopicRadiofrequency TherapyUnited StatesEnergy-based devicesFDA safety communicationVaginal cosmetic proceduresVaginal ‘rejuvenation’

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.