Bipolar Radiofrequency for Genitourinary Syndrome of Menopause

NCT07419035 | Not Yet Recruiting

• 2 other identifiers: Cquezada031395/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genitourinary Syndrome of Menopause (GSM)

Keywords

bipolar radiofrequency; menopause; sexual function; dyspareunia; vaginal atrophy; postmenopausal women; radiofrequency therapy

Outcome Measures

Primary Outcomes (2)

• Change in Sexual Function (FSFI Total Score)

  Sexual function will be assessed using the Female Sexual Function Index (FSFI). The primary endpoints are the changes in total FSFI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.

  Baseline, 1 week after completion of treatment, and 3 months after completion of treatment

• Change in Vaginal Health (Vaginal Health Index Total Score)

  Vaginal health will be assessed using the Vaginal Health Index (VHI). The primary endpoints are the changes in total VHI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.

  Baseline, 1 week after completion of treatment, and 3 months after completion of treatment

Secondary Outcomes (11)

• Change in Female Sexual Function Index Domain Scores

  Baseline, 1 week after completion of treatment, and 3 months after completion of treatment

• Change in Vaginal Health Index Component Scores

  Baseline, 1 week after completion of treatment, and 3 months after completion of treatment

• Change in the pain during vaginal penetration/distension

  Baseline, 1 week after completion of treatment, and 3 months after completion of treatment

• Change in Vaginal Distensibility Threshold (Phenix Pelvimeter)

  Baseline, immediately post-treatment, and 3 months post-treatment

• Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS)

  Baseline, 1 week after completion of treatment, and 3 months post-treatment

Study Arms (2)

Active Bipolar Radiofrequency

EXPERIMENTAL

Participants assigned to the active intervention group will receive six weekly sessions of bipolar radiofrequency therapy delivered according to a standardized protocol including external and intracavitary application.

Device: Active bipolar radiofrequency therapy

Sham Procedure

SHAM COMPARATOR

Participants assigned to the sham comparator group will undergo six weekly sessions replicating the structure and duration of the active protocol but without delivery of therapeutic radiofrequency energy.

Device: Sham radiofrequency procedure

Interventions

Active bipolar radiofrequency therapy DEVICE

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 controlled temperature maintained between 41-43°C and systematic rotation for uniform energy distribution; and a final 5-minute external capacitive application replicating the first phase.

Active Bipolar Radiofrequency

Sham radiofrequency procedure DEVICE

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.

Sham Procedure

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Individuals who self-identify as women and are postmenopausal, with anatomical eligibility for vaginal assessment and treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha

Toledo, Toledo, 45071, Spain

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordelo P. Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study. BMC Womens Health. 2021 Oct 30;21(1):379. doi: 10.1186/s12905-021-01518-8.

  PMID: 34717608 BACKGROUND

• Wattanakrai P, Limpjaroenviriyakul N, Thongtan D, Wattanayingcharoenchai R, Manonai J. The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial. Lasers Med Sci. 2022 Apr;37(3):1829-1842. doi: 10.1007/s10103-021-03438-3. Epub 2021 Oct 14.

  PMID: 34647191 BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• ASUNCIÓN FERRI-MORALES, PT, MSc

  University of Castilla-La Mancha

  STUDY DIRECTOR

Central Study Contacts

CLAUDIA QUEZADA-BASCUÑÁN, PT, MSc

CONTACT

+34652575842; claudia.quezada@uclm.es

ASUNCIÓN FERRI-MORALES, PT, PhD

CONTACT

+34 600 320 518; Asuncion.ferri@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to group assignment. Due to the thermal sensation associated with active bipolar radiofrequency and the absence of heat during sham, participants and treating operators will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 parallel-group design to receive either active bipolar radiofrequency treatment or a sham procedure, with no crossover. The allocation sequence will be generated using Epidat v4.2 software. Enrollment and assignment will be managed by a designated researcher using a secure randomization sequence inaccessible to enrollment personnel to ensure allocation concealment.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year after publication and ending 5 years after publication.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal for achieving the aims of the approved proposal. A data sharing agreement will be required. Requests should be directed to the corresponding author.

Locations

ES (1)