Genitourinary Syndrome of Menopause (GSM)BRF-GSMNCT07419035
Bipolar Radiofrequency for Genitourinary Syndrome of Menopause
A study testing Active bipolar radiofrequency therapy in people with Genitourinary Syndrome of Menopause (GSM), run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM)
- What is being tested?
- Active bipolar radiofrequency therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
University of Castilla-La Mancha
Toledo, Toledo, 45071
Claudia Quezada-Bascuñán, PT, MSc, +34652575842, claudia.quezada@uclm.es
CLAUDIA, claudia.quezada@uclm.es
About this study
Official title: Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical 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.
Read the 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.
- Being tested
- Active bipolar radiofrequency therapy, Sham radiofrequency procedure
- Keywords
- bipolar radiofrequency, menopause, sexual function, dyspareunia, vaginal atrophy, postmenopausal women, radiofrequency therapy
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active bipolar radiofrequency therapyDevice
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.
Sham radiofrequency procedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Bipolar Radiofrequency | Experimental | Participants assigned to the active intervention group will receive six weekly sessions of bipolar radiofrequency therapy delivered according to a standardized protocol including external and intracavitary application. Receives: Device: Active bipolar radiofrequency therapy |
| Sham Procedure | Sham comparator | Participants assigned to the sham comparator group will undergo six weekly sessions replicating the structure and duration of the active protocol but without delivery of therapeutic radiofrequency energy. Receives: Device: Sham radiofrequency procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Secondary outcomes (11)
Change in Female Sexual Function Index Domain Scores
Female Sexual Function Index domain scores: desire, arousal, lubrication, orgasm, satisfaction, and pain will be assessed.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
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.
Measured: Baseline, immediately post-treatment, and 3 months post-treatment
Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS)
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).
Measured: Baseline, 1 week after completion of treatment, and 3 months post-treatment
Change in Female Sexual Distress (FSDS-R)
Sexual distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Day-to-Day Impact of Vaginal Aging (DIVA Questionnaire)
Quality of life impact will be assessed using the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Health-Related Quality of Life
Evaluated with the Revised Female Sexual Distress Scale and the Day-to-Day Impact of Vaginal Aging Questionnaire
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Proportion of Participants Achieving Clinically Meaningful Improvement (Anchor-Based)
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.
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Treatment Satisfaction
Treatment satisfaction will be assessed using a single-item question: "Do you consider this change sufficient to justify continuing or recommending this treatment?"
Measured: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Incidence of Adverse Events
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.
Measured: From first session through 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ASUNCIÓN FERRI-MORALES, PT, MSc, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419035
- Sponsor's protocol ID
- Cquezada03
- Other IDs
- 1395/2025
- Acronym
- BRF-GSM
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request to the corresponding author. The study protocol will also be available upon request. Data will be shared for research purposes following approval of a methodologically sound proposal and completion of a data sharing agreement. Data will be available beginning 1 year after publication and ending 5 years following publication.
Publications
Cheng V, Chi-Shing WT, Lee A, Lee R. The effects of a real-time temperature monitoring non-ablative monopolar radiofrequency technology on vulvovaginal atrophy symptoms in postmenopausal Chinese women. J Cosmet Dermatol. 2024 Jun;23(6):2030-2043. doi: 10.1111/jocd.16251. Epub 2024 Mar 7.
PubMed 38450826Sarmento ACA, de Araujo Santos Camargo JD, de Freitas CL, Medeiros KS, Costa APF, Goncalves AK. Physical energies for the management of genitourinary syndrome of menopause: An overview of a systematic review and network meta-analysis. Int J Gynaecol Obstet. 2024 Jul;166(1):163-172. doi: 10.1002/ijgo.15304. Epub 2023 Dec 16.
PubMed 38102987Palacios S, Gonzalez SP, Fernandez-Abellan M, Manubens M, Garcia-Alfaro P; EVES Study Spanish investigators. Impact Of Vulvovaginal Atrophy Of Menopause In Spanish Women: Prevalence And Symptoms According To The EVES Study. Sex Med. 2019 Jun;7(2):207-216. doi: 10.1016/j.esxm.2019.01.005. Epub 2019 Mar 16.
PubMed 30885552Joris A, Di Pietrantonio V, Praet J, Renard K, Verduyn AC, Buxant F, Rozenberg S. Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency. Climacteric. 2024 Apr;27(2):210-214. doi: 10.1080/13697137.2024.2302425. Epub 2024 Jan 22.
PubMed 38251861Kumaran B, Watson T. Skin thermophysiological effects of 448 kHz capacitive resistive monopolar radiofrequency in healthy adults: A randomised crossover study and comparison with pulsed shortwave therapy. Electromagn Biol Med. 2018;37(1):1-12. doi: 10.1080/15368378.2017.1422260. Epub 2018 Jan 8.
PubMed 29308927Kolczewski P, Parafiniuk M, Zawodny P, Haddad R, Nalewczynska A, Kolasa AK, Wiszniewska B, Menkes S, Bader A, Stabile G, Zerbinati N. Hyaluronic Acid and Radiofrequency in Patients with Urogenital Atrophy and Vaginal Laxity. Pharmaceuticals (Basel). 2022 Dec 16;15(12):1571. doi: 10.3390/ph15121571.
PubMed 36559022Vanaman Wilson MJ, Bolton J, Jones IT, Wu DC, Calame A, Goldman MP. Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device. Dermatol Surg. 2018 May;44(5):705-713. doi: 10.1097/DSS.0000000000001453.
PubMed 29701623Gueldini de Moraes AV, Costa-Paiva L, da Costa Machado H, Maciel TF, Mariano FV, Pedro AO. Comparison of the effect of noninvasive radiofrequency with vaginal estrogen and vaginal moisturizer in the treatment of vulvovaginal atrophy in postmenopausal women: a randomized clinical trial. Menopause. 2024 Apr 1;31(4):288-302. doi: 10.1097/GME.0000000000002326. Epub 2024 Feb 26.
PubMed 38412393Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordelo P. Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study. BMC Womens Health. 2021 Oct 30;21(1):379. doi: 10.1186/s12905-021-01518-8.
PubMed 34717608Wattanakrai P, Limpjaroenviriyakul N, Thongtan D, Wattanayingcharoenchai R, Manonai J. The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial. Lasers Med Sci. 2022 Apr;37(3):1829-1842. doi: 10.1007/s10103-021-03438-3. Epub 2021 Oct 14.
PubMed 34647191
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07419035
- Acronym / sponsor ID
- BRF-GSM / Cquezada03
- Keywords
- bipolar radiofrequency, menopause, sexual function, dyspareunia, vaginal atrophy, postmenopausal women, radiofrequency therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Bipolar Radiofrequency | Experimental | Device: Active bipolar radiofrequency therapyParticipants assigned to the active intervention group will receive six weekly sessions of bipolar radiofrequency therapy delivered according to a standardized protocol including external and intracavitary application. |
| Sham Procedure | Sham comparator | Device: Sham radiofrequency procedureParticipants assigned to the sham comparator group will undergo six weekly sessions replicating the structure and duration of the active protocol but without delivery of therapeutic radiofrequency energy. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Active vaginal infection
- Neurological, neoplastic, or sexually transmitted diseases
- Diagnosis of vulvodynia or vaginismus
- Pelvic organ prolapse stage II or higher
- Pelviperineal hypoesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active bipolar radiofrequency therapyBipolar 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. | Device | Active Bipolar Radiofrequency |
| Sham radiofrequency procedureThe 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. | Device | Sham Procedure |
Primary outcome
Change in Sexual Function (FSFI Total Score)
Time frame: 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)
Time frame: 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.
11 secondary outcomes
Change in Female Sexual Function Index Domain Scores
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Vaginal Health Index Component Scores
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in the pain during vaginal penetration/distension
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Vaginal Distensibility Threshold (Phenix Pelvimeter)
Time frame: Baseline, immediately post-treatment, and 3 months post-treatment
Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS)
Time frame: Baseline, 1 week after completion of treatment, and 3 months post-treatment
Change in Female Sexual Distress (FSDS-R)
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Day-to-Day Impact of Vaginal Aging (DIVA Questionnaire)
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Change in Health-Related Quality of Life
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Proportion of Participants Achieving Clinically Meaningful Improvement (Anchor-Based)
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Treatment Satisfaction
Time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Incidence of Adverse Events
Time frame: From first session through 3 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 38450826Cheng V, Chi-Shing WT, Lee A, Lee R. The effects of a real-time temperature monitoring non-ablative monopolar radiofrequency technology on vulvovaginal atrophy symptoms in postmenopausal Chinese women. J Cosmet Dermatol. 2024 Jun;23(6):2030-2043. doi: 10.1111/jocd.16251. Epub 2024 Mar 7.
- Background: PubMed 38102987Sarmento ACA, de Araujo Santos Camargo JD, de Freitas CL, Medeiros KS, Costa APF, Goncalves AK. Physical energies for the management of genitourinary syndrome of menopause: An overview of a systematic review and network meta-analysis. Int J Gynaecol Obstet. 2024 Jul;166(1):163-172. doi: 10.1002/ijgo.15304. Epub 2023 Dec 16.
- Background: PubMed 30885552Palacios S, Gonzalez SP, Fernandez-Abellan M, Manubens M, Garcia-Alfaro P; EVES Study Spanish investigators. Impact Of Vulvovaginal Atrophy Of Menopause In Spanish Women: Prevalence And Symptoms According To The EVES Study. Sex Med. 2019 Jun;7(2):207-216. doi: 10.1016/j.esxm.2019.01.005. Epub 2019 Mar 16.
- Background: PubMed 38251861Joris A, Di Pietrantonio V, Praet J, Renard K, Verduyn AC, Buxant F, Rozenberg S. Randomized trial: treatment of genitourinary syndrome of menopause using radiofrequency. Climacteric. 2024 Apr;27(2):210-214. doi: 10.1080/13697137.2024.2302425. Epub 2024 Jan 22.
- Background: PubMed 29308927Kumaran B, Watson T. Skin thermophysiological effects of 448 kHz capacitive resistive monopolar radiofrequency in healthy adults: A randomised crossover study and comparison with pulsed shortwave therapy. Electromagn Biol Med. 2018;37(1):1-12. doi: 10.1080/15368378.2017.1422260. Epub 2018 Jan 8.
- Background: PubMed 36559022Kolczewski P, Parafiniuk M, Zawodny P, Haddad R, Nalewczynska A, Kolasa AK, Wiszniewska B, Menkes S, Bader A, Stabile G, Zerbinati N. Hyaluronic Acid and Radiofrequency in Patients with Urogenital Atrophy and Vaginal Laxity. Pharmaceuticals (Basel). 2022 Dec 16;15(12):1571. doi: 10.3390/ph15121571.
- Background: PubMed 29701623Vanaman Wilson MJ, Bolton J, Jones IT, Wu DC, Calame A, Goldman MP. Histologic and Clinical Changes in Vulvovaginal Tissue After Treatment With a Transcutaneous Temperature-Controlled Radiofrequency Device. Dermatol Surg. 2018 May;44(5):705-713. doi: 10.1097/DSS.0000000000001453.
- Background: PubMed 38412393Gueldini de Moraes AV, Costa-Paiva L, da Costa Machado H, Maciel TF, Mariano FV, Pedro AO. Comparison of the effect of noninvasive radiofrequency with vaginal estrogen and vaginal moisturizer in the treatment of vulvovaginal atrophy in postmenopausal women: a randomized clinical trial. Menopause. 2024 Apr 1;31(4):288-302. doi: 10.1097/GME.0000000000002326. Epub 2024 Feb 26.
- Background: PubMed 34717608Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordelo P. Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study. BMC Womens Health. 2021 Oct 30;21(1):379. doi: 10.1186/s12905-021-01518-8.
- Background: PubMed 34647191Wattanakrai P, Limpjaroenviriyakul N, Thongtan D, Wattanayingcharoenchai R, Manonai J. The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial. Lasers Med Sci. 2022 Apr;37(3):1829-1842. doi: 10.1007/s10103-021-03438-3. Epub 2021 Oct 14.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication will be made available upon reasonable request to the corresponding author. The study protocol will also be available upon request. Data will be shared for research purposes following approval of a methodologically sound proposal and completion of a data sharing agreement. Data will be available beginning 1 year after publication and ending 5 years following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ASUNCIÓN FERRI-MORALES, PT, MSc study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active bipolar radiofrequency therapy in people with Genitourinary Syndrome of Menopause (GSM), run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLAUDIA QUEZADA-BASCUÑÁN, PT, MSc (+34652575842, claudia.quezada@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Function (FSFI Total Score) (time frame: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419035, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.