Bipolar Radiofrequency for Genitourinary Syndrome of Menopause

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• Device 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.

Primary outcome measures

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

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• University of Castilla-La Mancha — Toledo

Publications

• 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

Identifiers

NCT: NCT07419035 · Cquezada03 · 1395/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗