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

University of Castilla-La Mancha

Status: Not yet enrolling

Conditions: Genitourinary Syndrome of Menopause (GSM)

Treatments: Device: Active bipolar radiofrequency therapy; Device: Sham radiofrequency procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT07419035

Cquezada03

1395/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Active Bipolar Radiofrequency

Experimental group

Description:

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.

Treatment:

Device: Active bipolar radiofrequency therapy

Sham Procedure

Sham Comparator group

Description:

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.

Treatment:

Device: Sham radiofrequency procedure