Genitourinary Syndrome of Menopause (GSM)
Conditions
Keywords
bipolar radiofrequency, menopause, sexual function, dyspareunia, vaginal atrophy, postmenopausal women, radiofrequency therapy
Brief 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.
Detailed description
Genitourinary syndrome of menopause (GSM) is a chronic condition related to hypoestrogenism that commonly results in vulvovaginal dryness, burning, irritation, dyspareunia, and urinary symptoms, with meaningful impact on vaginal and sexual function and overall quality of life. While hormonal therapies are effective for many patients, non-hormonal treatment alternatives are needed for women who prefer to avoid hormones or have contraindications. Bipolar radiofrequency is a non-ablative energy-based modality intended to promote tissue remodeling and improve vaginal mucosal and connective tissue characteristics. This study is designed to generate rigorous evidence regarding the clinical efficacy and safety of bipolar radiofrequency for GSM. This study is a randomized, parallel-group, sham-controlled clinical trial designed to evaluate the efficacy and safety of bipolar radiofrequency in postmenopausal women with GSM. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure. The co-primary outcomes are sexual function, assessed using the Female Sexual Function Index (FSFI), and vaginal health, assessed using the Vaginal Health Index (VHI). Outcomes will be evaluated at baseline, immediately post-treatment, and three months after completion of treatment. Secondary outcomes include pain with vaginal penetration, vaginal lubrication and tissue distensibility, vulvovaginal symptom severity scores, and treatment safety and tolerability. In addition to statistical significance, the study will assess clinical relevance by examining whether observed improvements meet or exceed thresholds for clinically meaningful change (minimal clinically important difference and clinical relevance of the treatment) where established, to support interpretation of treatment benefit.
Interventions
DEVICEActive bipolar radiofrequency therapy
Bipolar 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.
DEVICESham radiofrequency procedure
The 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.
Sponsors
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be masked to group assignment. Due to the thermal sensation associated with active bipolar radiofrequency and the absence of heat during sham, participants and treating operators will not be masked.
Intervention model description
Participants will be randomized in a 1:1 parallel-group design to receive either active bipolar radiofrequency treatment or a sham procedure, with no crossover. The allocation sequence will be generated using Epidat v4.2 software. Enrollment and assignment will be managed by a designated researcher using a secure randomization sequence inaccessible to enrollment personnel to ensure allocation concealment.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Function (FSFI Total Score) | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | 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. |
| Change in Vaginal Health (Vaginal Health Index Total Score) | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Female Sexual Function Index Domain Scores | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Female Sexual Function Index domain scores: desire, arousal, lubrication, orgasm, satisfaction, and pain will be assessed. |
| Change in Vaginal Health Index Component Scores | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Vaginal Health Index component scores: elasticity, vaginal fluid volume, vaginal pH, epithelial integrity, and moisture will be assessed. |
| Change in the pain during vaginal penetration/distension | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | 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. |
| Change in Vaginal Distensibility Threshold (Phenix Pelvimeter) | Baseline, immediately post-treatment, and 3 months post-treatment | 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. |
| Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS) | Baseline, 1 week after completion of treatment, and 3 months post-treatment | Symptom severity: vaginal dryness, irritation, burning/itching, pain/discomfort with vaginal penetration, postcoital bleeding, urinary frequency/urgency, and urinary leakage will be rated on a 0-10 numerical rating scale (0 = none; 10 = worst). |
| Change in Female Sexual Distress (FSDS-R) | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Sexual distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R). |
| Change in Day-to-Day Impact of Vaginal Aging (DIVA Questionnaire) | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Quality of life impact will be assessed using the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. |
| Change in Health-Related Quality of Life | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Evaluated with the Revised Female Sexual Distress Scale and the Day-to-Day Impact of Vaginal Aging Questionnaire |
| Proportion of Participants Achieving Clinically Meaningful Improvement (Anchor-Based) | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | The proportion of participants achieving clinically meaningful improvement in sexual function and pain outcomes will be determined using an anchor-based approach with the Global Rating of Change scale. |
| Treatment Satisfaction | Baseline, 1 week after completion of treatment, and 3 months after completion of treatment | Treatment satisfaction will be assessed using a single-item question: "Do you consider this change sufficient to justify continuing or recommending this treatment?" |
| Incidence of Adverse Events | From first session through 3 months post-treatment | Adverse events were defined as any undesirable local reactions, such as pain, burning, bleeding, or discomfort, occurring during or after the intervention. They were assessed at each visit through direct questioning by clinical staff, and participant-reported events were recorded. Adverse events will be collected after each radiofrequency session by direct observation and through participant self-report during the treatment period and follow-up. |
Countries
Spain
Contacts
CONTACTCLAUDIA QUEZADA-BASCUÑÁN, PT, MSc
CONTACTASUNCIÓN FERRI-MORALES, PT, PhD
STUDY_DIRECTORASUNCIÓN FERRI-MORALES, PT, MSc
University of Castilla-La Mancha
Outcome results
None listed