Bipolar Radiofrequency for Genitourinary Syndrome of Menopause

Официальное название

Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial

Обзор

This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure. The primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.

Подробное описание

Genitourinary syndrome of menopause (GSM) is a chronic condition related to hypoestrogenism that commonly results in vulvovaginal dryness, burning, irritation, dyspareunia, and urinary symptoms, with meaningful impact on vaginal and sexual function and overall quality of life. While hormonal therapies are effective for many patients, non-hormonal treatment alternatives are needed for women who prefer to avoid hormones or have contraindications.

Bipolar radiofrequency is a non-ablative energy-based modality intended to promote tissue remodeling and improve vaginal mucosal and connective tissue characteristics. This study is designed to generate rigorous evidence regarding the clinical efficacy and safety of bipolar radiofrequency for GSM.

This study is a randomized, parallel-group, sham-controlled clinical trial designed to evaluate the efficacy and safety of bipolar radiofrequency in postmenopausal women with GSM. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure.

The co-primary outcomes are sexual function, assessed using the Female Sexual Function Index (FSFI), and vaginal health, assessed using the Vaginal Health Index (VHI). Outcomes will be evaluated at baseline, immediately post-treatment, and three months after completion of treatment.

Secondary outcomes include pain with vaginal penetration, vaginal lubrication and tissue distensibility, vulvovaginal symptom severity scores, and treatment safety and tolerability.

In addition to statistical significance, the study will assess clinical relevance by examining whether observed improvements meet or exceed thresholds for clinically meaningful change (minimal clinically important difference and clinical relevance of the treatment) where established, to support interpretation of treatment benefit.

Вмешательства

• Устройство Active bipolar radiofrequency therapy
  Bipolar radiofrequency will be delivered using a non-ablative medical device for vulvovaginal tissue remodeling. Participants will receive six weekly sessions lasting approximately 40 minutes each. Each session will include three phases: an initial 5-minute external application using a capacitive electrode applied to the perineal and vulvar areas with gradual thermal increase to a comfortable sensation (approximately 4-5/10); a 10-minute intracavitary phase using a bipolar electrode with control
• Устройство Sham radiofrequency procedure
  The sham procedure will replicate the structure, duration, electrode placement, and anatomical application sites of the active intervention. Participants will undergo six weekly sessions lasting approximately 40 minutes, including an initial 5-minute external application to the perineal and vulvar areas, a 10-minute intracavitary electrode placement, and a final 5-minute external application. However, no therapeutic radiofrequency energy or thermal increase will be delivered.

Первичные конечные точки

• Change in Sexual Function (FSFI Total Score) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in Vaginal Health (Vaginal Health Index Total Score) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]

Вторичные конечные точки (11)

• Change in Female Sexual Function Index Domain Scores [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in Vaginal Health Index Component Scores [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in the pain during vaginal penetration/distension [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in Vaginal Distensibility Threshold (Phenix Pelvimeter) [Срок оценки: Baseline, immediately post-treatment, and 3 months post-treatment]
• Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months post-treatment]
• Change in Female Sexual Distress (FSDS-R) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in Day-to-Day Impact of Vaginal Aging (DIVA Questionnaire) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Change in Health-Related Quality of Life [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Proportion of Participants Achieving Clinically Meaningful Improvement (Anchor-Based) [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Treatment Satisfaction [Срок оценки: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment]
• Incidence of Adverse Events [Срок оценки: From first session through 3 months post-treatment]

Критерии участия

Критерии включения

• Women aged 40 to 65 years
• Postmenopausal status
• Presence of at least one symptom of genitourinary syndrome of menopause (e.g., vaginal dryness, irritation, pruritus, urinary symptoms, or dyspareunia)
• Sexual activity at least once per month
• Ability to understand and complete study questionnaires
• Provision of written informed consent

Критерии исключения

• Active vaginal infection
• Neurological, neoplastic, or sexually transmitted diseases
• Diagnosis of vulvodynia or vaginismus
• Pelvic organ prolapse stage II or higher
• Pelviperineal hypoesthesia
• Presence of pacemaker or other electronic implantable devices
• Use of estrogen hormonal therapy within the previous 3 months
• History of pelvic radiotherapy
• Pelvic surgery within the previous 6 months
• Active anticoagulant therapy
• Previous vaginal laser or ablative vaginal rejuvenation procedures within the previous 6 months
• Cognitive impairment preventing completion of questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University of Castilla-La Mancha — Toledo

Публикации

• Cheng V, Chi-Shing WT, Lee A, Lee R. The effects of a real-time temperature monitoring non-ablative monopolar radiofrequency technology on vulvovaginal atrophy symptoms in postmenopausal Chinese women. J Cosmet Dermatol. 2024 Jun;23(6):2030-2043. doi: 10.1111/jocd.16251. Epub 2024 Mar 7. PMID 38450826
• Sarmento ACA, de Araujo Santos Camargo JD, de Freitas CL, Medeiros KS, Costa APF, Goncalves AK. Physical energies for the management of genitourinary syndrome of menopause: An overview of a systematic review and network meta-analysis. Int J Gynaecol Obstet. 2024 Jul;166(1):163-172. doi: 10.1002/ijgo.15304. Epub 2023 Dec 16. PMID 38102987
• Palacios S, Gonzalez SP, Fernandez-Abellan M, Manubens M, Garcia-Alfaro P; EVES Study Spanish investigators. Impact Of Vulvovaginal Atrophy Of Menopause In Spanish Women: Prevalence And Symptoms According To The EVES Study. Sex Med. 2019 Jun;7(2):207-216. doi: 10.1016/j.esxm.2019.01.005. Epub 2019 Mar 16. PMID 30885552
• Joris A, Di Pietrantonio V, Praet J, Renard K, Verduyn AC, Buxant F, Rozenberg S. Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency. Climacteric. 2024 Apr;27(2):210-214. doi: 10.1080/13697137.2024.2302425. Epub 2024 Jan 22. PMID 38251861
• Kumaran B, Watson T. Skin thermophysiological effects of 448 kHz capacitive resistive monopolar radiofrequency in healthy adults: A randomised crossover study and comparison with pulsed shortwave therapy. Electromagn Biol Med. 2018;37(1):1-12. doi: 10.1080/15368378.2017.1422260. Epub 2018 Jan 8. PMID 29308927
• Kolczewski P, Parafiniuk M, Zawodny P, Haddad R, Nalewczynska A, Kolasa AK, Wiszniewska B, Menkes S, Bader A, Stabile G, Zerbinati N. Hyaluronic Acid and Radiofrequency in Patients with Urogenital Atrophy and Vaginal Laxity. Pharmaceuticals (Basel). 2022 Dec 16;15(12):1571. doi: 10.3390/ph15121571. PMID 36559022
• Vanaman Wilson MJ, Bolton J, Jones IT, Wu DC, Calame A, Goldman MP. Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device. Dermatol Surg. 2018 May;44(5):705-713. doi: 10.1097/DSS.0000000000001453. PMID 29701623
• Gueldini de Moraes AV, Costa-Paiva L, da Costa Machado H, Maciel TF, Mariano FV, Pedro AO. Comparison of the effect of noninvasive radiofrequency with vaginal estrogen and vaginal moisturizer in the treatment of vulvovaginal atrophy in postmenopausal women: a randomized clinical trial. Menopause. 2024 Apr 1;31(4):288-302. doi: 10.1097/GME.0000000000002326. Epub 2024 Feb 26. PMID 38412393

Идентификаторы

NCT: NCT07419035 · Cquezada03 · 1395/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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