Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorUniversity of Castilla-La Mancha
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Active vaginal infection
Neurological, neoplastic, or sexually transmitted diseases
Diagnosis of vulvodynia or vaginismus
Pelvic organ prolapse stage II or higher
Trial design
Treatments tested in this trial
- Active bipolar radiofrequency therapy
- Sham radiofrequency procedure
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov