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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active bipolar radiofrequency therapy
DeviceBipolar radiofrequency will be delivered using a non-ablative medical device for vulvovaginal tissue remodeling. Participants will receive six weekly sessions lasting approximately 40 minutes each. Each session will include three phases: an initial 5-minute external application using a capacitive electrode applied to the perineal and vulvar areas with gradual thermal increase to a comfortable sensation (approximately 4-5/10); a 10-minute intracavitary phase using a bipolar electrode with controlled temperature maintained between 41-43°C and systematic rotation for uniform energy distribution; and a final 5-minute external capacitive application replicating the first phase.
Sham radiofrequency procedure
DeviceThe sham procedure will replicate the structure, duration, electrode placement, and anatomical application sites of the active intervention. Participants will undergo six weekly sessions lasting approximately 40 minutes, including an initial 5-minute external application to the perineal and vulvar areas, a 10-minute intracavitary electrode placement, and a final 5-minute external application. However, no therapeutic radiofrequency energy or thermal increase will be delivered.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active Bipolar RadiofrequencyExperimental treatment 1 intervention
Group B: Sham ProcedureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Sexual Function (FSFI Total Score)
Sexual function will be assessed using the Female Sexual Function Index (FSFI). The primary endpoints are the changes in total FSFI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.
Time frame
Baseline, 1 week after completion of treatment, and 3 months after completion of treatment2
Change in Vaginal Health (Vaginal Health Index Total Score)
Vaginal health will be assessed using the Vaginal Health Index (VHI). The primary endpoints are the changes in total VHI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.
Time frame
Baseline, 1 week after completion of treatment, and 3 months after completion of treatmentSecondary outcomes
1
Change in Female Sexual Function Index Domain Scores
Female Sexual Function Index domain scores: desire, arousal, lubrication, orgasm, satisfaction, and pain will be assessed.
Time frame
Baseline, 1 week after completion of treatment, and 3 months after completion of treatment2
Change in Vaginal Health Index Component Scores
Vaginal Health Index component scores: elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and moisture will be assessed.
Time frame
Baseline, 1 week after completion of treatment, and 3 months after completion of treatment3
Change in the pain during vaginal penetration/distension
Pain intensity during vaginal penetration/distension will be assessed using a 0-10 numerical rating scale (0 = no pain; 10 = worst imaginable pain) during standardised use of vaginal dilators.
Time frame
Baseline, 1 week after completion of treatment, and 3 months after completion of treatment4
Change in Vaginal Distensibility Threshold (Phenix Pelvimeter)
Vaginal distensibility will be assessed using the Phenix pelvimeter. The distensibility threshold will be recorded as the opening degree at which the participant reports pain level.
Time frame
Baseline, immediately post-treatment, and 3 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov
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