NCT07419035Not yet recruiting
Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 15 Mar 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- University of Castilla-La Mancha
- NCT number
- NCT07419035
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 Mar 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of estrogen hormonal therapy within the previous 3 months
- Pelvic surgery within the previous 6 months
- Active anticoagulant therapy
- Previous vaginal laser or ablative vaginal rejuvenation procedures within the previous 6 months
Other illness
- Active vaginal infection
- Neurological, neoplastic, or sexually transmitted diseases
- History of pelvic radiotherapy
- Cognitive impairment preventing completion of questionnaires
Other
- Diagnosis of vulvodynia or vaginismus
- Pelvic organ prolapse stage II or higher
- Pelviperineal hypoesthesia
- Presence of pacemaker or other electronic implantable devices
Who the study is looking for
- 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
Age in the registry: 40 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Castilla-La Mancha Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.