An interventional study of Active bipolar radiofrequency therapy and Sham radiofrequency procedure in Genitourinary Syndrome of Menopause (GSM), sponsored by University of Castilla-La Mancha. Not yet recruiting at 1 site in Spain. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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.
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.
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.
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)
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.
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Female Sexual Function Index Domain Scores
Female Sexual Function Index domain scores: desire, arousal, lubrication, orgasm, satisfaction, and pain will be assessed.
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Vaginal Health Index Component Scores
Vaginal Health Index component scores: elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and moisture will be assessed.
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in the pain during vaginal penetration/distension
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.
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Vaginal Distensibility Threshold (Phenix Pelvimeter)
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.
Time frame: Baseline, immediately post-treatment, and 3 months post-treatment
Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS)
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).
Time frame: Baseline, 1 week after completion of treatment, and 3 months post-treatment
Change in Female Sexual Distress (FSDS-R)
Sexual distress will be assessed using the Female Sexual Distress Scale-Revised (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)
Quality of life impact will be assessed using the 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
Evaluated with the Revised Female Sexual Distress Scale and the Day-to-Day Impact of Vaginal Aging Questionnaire
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)
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.
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Treatment Satisfaction
Treatment satisfaction will be assessed using a single-item question: "Do you consider this change sufficient to justify continuing or recommending this treatment?"
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Incidence of Adverse Events
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.
Time frame: From first session through 3 months post-treatment
Plan to share: Yes — 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.
Supporting information: Study protocol
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University of Castilla-La Mancha