Bipolar Radiofrequency for Genitourinary Syndrome of Menopause (BRF-GSM)

February 11, 2026 updated by: University of Castilla-La Mancha

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Toledo
      • Toledo, Toledo, Spain, 45071
        • University of Castilla-La Mancha
        • Contact:
        • Contact:
        • Principal Investigator:
          • CLAUDIA QUEZADA BASCUÑÁN, PT, MSc
        • Principal Investigator:
          • ASUNCIÓN FERRI-MORALES, PT, PhD
        • Principal Investigator:
          • CRISTINA LIRIO-ROMERO, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Bipolar Radiofrequency
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
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.
Sham Comparator: Sham Procedure
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sexual Function (FSFI Total Score)
Time Frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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)
Time Frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Female Sexual Function Index Domain Scores
Time Frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Female Sexual Function Index domain scores: desire, arousal, lubrication, orgasm, satisfaction, and pain will be assessed.
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
Vaginal Health Index component scores: elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and moisture will be assessed.
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
Pain intensity during vaginal penetration/distension will be assessed using a 0-10 numerical rating scale (0 = no pain; 10 = worst imaginable pain) during standardised use of vaginal dilators.
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
Vaginal distensibility will be assessed using the Phenix pelvimeter. The distensibility threshold will be recorded as the opening degree at which the participant reports pain level.
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
Symptom severity: vaginal dryness, irritation, burning/itching, pain/discomfort with vaginal penetration, postcoital bleeding, urinary frequency/urgency, and urinary leakage will be rated on a 0-10 numerical rating scale (0 = none; 10 = worst).
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
Sexual distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).
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
Quality of life impact will be assessed using the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire.
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
Evaluated with the Revised Female Sexual Distress Scale and the Day-to-Day Impact of Vaginal Aging Questionnaire
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
The proportion of participants achieving clinically meaningful improvement in sexual function and pain outcomes will be determined using an anchor-based approach with the Global Rating of Change scale.
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
Treatment satisfaction will be assessed using a single-item question: "Do you consider this change sufficient to justify continuing or recommending this treatment?"
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

Adverse events were defined as any undesirable local reactions, such as pain, burning, bleeding, or discomfort, occurring during or after the intervention. They were assessed at each visit through direct questioning by clinical staff, and participant-reported events were recorded.

Adverse events will be collected after each radiofrequency session by direct observation and through participant self-report during the treatment period and follow-up.
From first session through 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Investigators

  • Study Director: ASUNCIÓN FERRI-MORALES, PT, MSc, University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cquezada03
  • 1395/2025 (Other Identifier: Ethics Committee of the Toledo Health Area)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request to the corresponding author. The study protocol will also be available upon request. Data will be shared for research purposes following approval of a methodologically sound proposal and completion of a data sharing agreement. Data will be available beginning 1 year after publication and ending 5 years following publication.

IPD Sharing Time Frame

Beginning 1 year after publication and ending 5 years after publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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