Bipolar Radiofrequency for Genitourinary Syndrome of Menopause (NCT07419035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
Spain40 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sexual Function (FSFI Total Score)
Timeframe: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
2
Change in Vaginal Health (Vaginal Health Index Total Score)
Timeframe: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment