Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
Starting soon · Not applicable · Has a placebo group
Conditions studied: Genitourinary Syndrome of Menopause (GSM)
In brief
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.
Key facts
- Study ID
- NCT07419035
- Run by
- University of Castilla-La Mancha
- People needed
- 40
- Starts
- 2026-03-15
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-02-18
Who can join
Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- University of Castilla-La Mancha — Toledo, Toledo, Spain
Full record on ClinicalTrials.gov
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