Genitourinary Syndrome of MenopauseNCT06925139
Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women
A study testing Non-ablative monopolar radiofrequency treatment in people with Genitourinary Syndrome of Menopause and Vaginal Health, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
This study will test if non-ablative monopolar radiofrequency can help improve vaginal tissue and reduce symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. 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, Vaginal Health, Sexual Dysfunction
- What is being tested?
- Non-ablative monopolar radiofrequency treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age between 40 and 65 years.
- Postmenopausal women (defined as no menstrual period for at least 12 months).
- Experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), such as vaginal dryness, irritation, or discomfort.
- Experiencing discomfort or complaints during vaginal penetration. Engaging in sexual activity (at least once a month).
- Willing to participate in the study and sign the informed consent form.
Who cannot join
- Presenting with active vaginal infections.
- Presence of neurological, neoplastic, or sexually transmitted diseases.
- Presenting with vulvodynia or vaginismus.
- Prolapse grade 2 or higher.
- Presenting with altered sensitivity in the pelvic area.
- Being a pacemaker carrier or having any device that contains batteries.
Show all 12Show fewer
- Hormonal treatment with estrogens in the last 3 months.
- History of radiotherapy in the pelvic area.
- Recent pelvic surgery (within the last 6 months).
- Being on anticoagulant treatment.
- Having undergone laser treatment in the pelvic area or ablative vaginal rejuvenation in the last 6 months.
- Cognitive impairment that prevents answering the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women: a Randomized Clinical Trial
This study will test if non-ablative monopolar radiofrequency can help improve vaginal tissue and reduce symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. The study is a randomized, sham-controlled clinical trial in which participants and outcome assessors were masked to treatment allocation. The study will examine the impact of the treatment on sexual function, vaginal health, and quality of life over an extended period. There will be two groups in the study: one will receive the non-ablative monopolar radiofrequency treatment, and the other will receive the placebo treatment. Participants will have six treatment sessions and will be checked at the start, end, and three months post-treatment.
Read the detailed description
The purpose of this study is to evaluate the efficacy of non-ablative monopolar radiofrequency (RF) treatment in improving vaginal tissue regeneration and alleviating symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. This randomized clinical trial will include two groups: one receiving the active RF treatment and the other receiving a placebo treatment. The study will include six treatment sessions for each participant, with evaluations conducted at baseline, at the end of the treatment period, and three months post-treatment.
The sample size was calculated to detect a between-group difference of 4.5 points in the total FSFI score, with a two-sided α of 0.05, 80% power, and an assumed standard deviation of 6. Allowing for an anticipated 10% attrition rate, 31 participants per group were required (total N = 62).
Participants will be postmenopausal women who have experienced more than one year of amenorrhea and exhibit symptoms of GSM, such as vaginal dryness, irritation, and sexual dysfunction.
The primary outcome measures will include improvements in vaginal health assessed through clinical examination and patient-reported outcomes related to sexual function.
Secondary outcome measures will involve the analysis of vaginal pH, the maturation index of vaginal epithelial cells, and any adverse events reported during the study. The intervention involves the use of a non-ablative monopolar RF device applied intracavitarily. The placebo group will undergo the same procedure without the active RF component.
The study is conducted in accordance with ethical standards and has been reviewed and approved by the Ethics Committee for Clinical Research with Medicines of the City of Toledo. Data will be collected and analyzed to determine the effectiveness of the treatment in comparison to the placebo, and results will contribute to the understanding of non-ablative RF treatments in menopausal health.
- Being tested
- Non-ablative monopolar radiofrequency treatment
- Keywords
- Non-ablative radiofrequency, Vaginal Health, Sexual Health, Postmenopause, Genitourinary Syndrome of Menopause, Sexual Dysfunction, Women's Health
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative monopolar radiofrequency treatmentDevice
Protocol for the experimental group:
Tissue preparation phase: 5 minutes with the circular resistive monopolar electrode, applying slow circular or semicircular movements in the perineal area. The temperature will be gradually increased based on the patient's temperature perception, ensuring it remains comfortable (approximately 5 out of 10).
Main phase: 10 minutes using the intracavitary capacitive electrode connected to the PLUMA handle, lightly resting it on the tissues and continuously moving the electrode. The intravaginal temperature was maintained at 41-43°C throughout the 10-minute intracavitary application.
Final phase: 5 minutes with the circular resistive monopolar electrode, applying it similarly to the preparatory phase, with a subthermal effect, reaching a self-reported thermal sensation of 3 to 4 out of 10.
Participants in this group will receive the same treatment protocol, but with radiofrequency energy disabled.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 6 treatment sessions of non-ablative radiofrequency, with a frequency of 1 session per week. The following protocol will be followed: Preparation (5 minutes): Resistive monopolar electrode applied to vulvar area with gradual heating (sensation 4-5/10).
Main Phase (10 minutes): Intracavitary capacitive electrode used to reach and maintain 41-43°C throughout the 10-minute application.
Final Phase (5 minutes): Repeat resistive electrode application with subthermal effect (sensation 3-4/10). Receives: Device: Non-ablative monopolar radiofrequency treatment |
| Placebo Group | Sham comparator | Participants in this group will receive the same treatment protocol, but without the application of heat. Receives: Device: Non-ablative monopolar radiofrequency treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Female Sexual Function Index (FSFI)
Multidimensional questionnaire evaluates sexual function over the past 4 weeks. The total score ranges from 2.0 (severe dysfunction) to 36.0 (no dysfunction). Sexual dysfunction was defined as a score equal to or below 26.55
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal Health Index (VHI)
A tool that evaluates five parameters: vaginal elasticity, vaginal secretion (type and consistency), pH, mucosal epithelial integrity, and vaginal moisture. Each parameter was scored on a scale from 1 (most unfavorable condition) to 5 (optimal condition), with a maximum possible score of 25 points. In cases where the score was below 15, the vagina was considered atrophic.
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Secondary outcomes (17)
Change in sexual desire
Assessed by Female Sexual Function Index in individual domain of sexual desire. Score from 1,2 (worst) to 6 (best)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual arousal
Assessed by Female Sexual Function Index in individual domain of sexual arousal. Score from 0 (worst) to 6 (best)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual lubrication
Assessed by Female Sexual Function Index in individual domain of sexual lubrication. Score from 1,2 (worst) to 6 (best)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual orgasm
Assessed by Female Sexual Function Index in individual domain of sexual orgasm. Score from 0 (worst) to 6 (best)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual satisfaction
Assessed by Female Sexual Function Index in individual domain of sexual satisfaction. Score from 0.8 (worst) to 6 (best)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual pain
Assessed by Female Sexual Function Index in individual domain of sexual pain. Score from 0 (the worst possible pain) to 6 (no pain).
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Elasticity
Assessed by Vaginal Health Index in individual domain of vaginal elasticity. Score from 1 (most unfavorable condition) to 5 (optimal condition)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal secretion
Assessed by Vaginal Health Index in individual domain of vaginal secretion. Score from 1 (most unfavorable condition) to 5 (optimal condition)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal pH
Assessed by Vaginal Health Index in individual domain of vaginal pH. Score from 1 (most unfavorable condition) to 5 (optimal condition)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Ephitelial integrity
Assessed by Vaginal Health Index in individual domain of vaginal ephitelial integrity. Score from 1 (most unfavorable condition) to 5 (optimal condition)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Moisture
Assessed by Vaginal Health Index in individual domain of vaginal moisture. Score from 1 (most unfavorable condition) to 5 (optimal condition)
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal Maturity Index
The proportion of parabasal, intermediate, and superficial cells in each 100 cells counted on a smear of the upper two-thirds of the vagina.
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Status Estrogen
This index will be calculated using Meisels' formula: (% intermediate cells × 0.5 + % superficial cells).
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal Laxity Questionnaire (VLQ)
7-point Likert-type subjective scale, ranging from very loose to very tight. Scores below 4 (neither loose nor tight) indicate vaginal laxity.
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Pain assessed by NRS
Pain intensity perceived during the insertion of vaginal dilators of varying diameters (ranging from 20 to 30 mm) will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 represents the worst possible pain.
Measured: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Urinary Symptoms by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
It is a brief 4-item questionnaire designed to assess the frequency, severity, and impact of urinary incontinence on quality of life.
Measured: Baseline, end of treatment period (5 weeks), and three months post-treatment.
Change in Health- related quality of Life by SF-12
It consists of 12 items that yield two summary scores: physical and mental components. The response options follow a Likert-type scale that measures either intensity or frequency. Scale scores range from 0 to 100, with 0 indicating the worst health status and 100 the best.
Measured: Baseline, end of treatment period (6 weeks), and three 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 posted13 Apr 2025
- Study start15 Jun 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- This study is a randomized clinical trial with two parallel groups. Participants are randomly assigned to one of two groups: the treatment group receiving non-ablative monopolar radiofrequency and the placebo group receiving a sham procedure. The study includes six treatment sessions for each participant, with evaluations conducted at baseline, at the end of the treatment period, and three months post-treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Quezada Bascuñán, Ms, Principal investigator, University of Castilla-La ManchaAsunción Ferri Morales, PhD, Study chair, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925139
- Sponsor's protocol ID
- MEN_RF_01
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. Int J Womens Health. 2018 Jul 31;10:387-395. doi: 10.2147/IJWH.S158913. eCollection 2018.
PubMed 30104904Potter N, Panay N. Vaginal lubricants and moisturizers: a review into use, efficacy, and safety. Climacteric. 2021 Feb;24(1):19-24. doi: 10.1080/13697137.2020.1820478. Epub 2020 Sep 29.
PubMed 32990054Wiegerinck AIP, Thomsen A, Hisdal J, Kalvoy H, Tronstad C. Electrical Impedance Plethysmography Versus Tonometry To Measure the Pulse Wave Velocity in Peripheral Arteries in Young Healthy Volunteers: a Pilot Study. J Electr Bioimpedance. 2021 Dec 30;12(1):169-177. doi: 10.2478/joeb-2021-0020. eCollection 2021 Jan.
PubMed 35111272Shifren JL, Crandall CJ, Manson JE. Menopausal Hormone Therapy. JAMA. 2019 Jun 25;321(24):2458-2459. doi: 10.1001/jama.2019.5346. No abstract available.
PubMed 31145419Roy S, Caillouette JC, Roy T, Faden JS. Vaginal pH is similar to follicle-stimulating hormone for menopause diagnosis. Am J Obstet Gynecol. 2004 May;190(5):1272-7. doi: 10.1016/j.ajog.2003.12.015.
PubMed 15167829undefined
Tan O, Bradshaw K, Carr BR. Management of vulvovaginal atrophy-related sexual dysfunction in postmenopausal women: an up-to-date review. Menopause. 2012 Jan;19(1):109-17. doi: 10.1097/gme.0b013e31821f92df.
PubMed 22011753Sarmento ACA, Costa APF, Vieira-Baptista P, Giraldo PC, Eleuterio J Jr, Goncalves AK. Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic. Front Reprod Health. 2021 Nov 15;3:779398. doi: 10.3389/frph.2021.779398. eCollection 2021.
PubMed 36304000Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
PubMed 25841598
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06925139
- Acronym / sponsor ID
- MEN_RF_01
- Keywords
- Non-ablative radiofrequency, Vaginal Health, Sexual Health, Postmenopause, Genitourinary Syndrome of Menopause, Sexual Dysfunction, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Apr 2025 (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 study will test if non-ablative monopolar radiofrequency can help improve vaginal tissue and reduce symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. The study is a randomized, sham-controlled clinical trial in which participants and outcome assessors were masked to treatment allocation. The study will examine the impact of the treatment on sexual function, vaginal health, and quality of life over an extended period. There will be two groups in the study: one will receive the non-ablative monopolar radiofrequency treatment, and the other will receive the placebo treatment. Participants will have six treatment sessions and will be checked at the start, end, and three months post-treatment.
Detailed description
The purpose of this study is to evaluate the efficacy of non-ablative monopolar radiofrequency (RF) treatment in improving vaginal tissue regeneration and alleviating symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. This randomized clinical trial will include two groups: one receiving the active RF treatment and the other receiving a placebo treatment. The study will include six treatment sessions for each participant, with evaluations conducted at baseline, at the end of the treatment period, and three months post-treatment.
The sample size was calculated to detect a between-group difference of 4.5 points in the total FSFI score, with a two-sided α of 0.05, 80% power, and an assumed standard deviation of 6. Allowing for an anticipated 10% attrition rate, 31 participants per group were required (total N = 62).
Participants will be postmenopausal women who have experienced more than one year of amenorrhea and exhibit symptoms of GSM, such as vaginal dryness, irritation, and sexual dysfunction.
The primary outcome measures will include improvements in vaginal health assessed through clinical examination and patient-reported outcomes related to sexual function.
Secondary outcome measures will involve the analysis of vaginal pH, the maturation index of vaginal epithelial cells, and any adverse events reported during the study. The intervention involves the use of a non-ablative monopolar RF device applied intracavitarily. The placebo group will undergo the same procedure without the active RF component.
The study is conducted in accordance with ethical standards and has been reviewed and approved by the Ethics Committee for Clinical Research with Medicines of the City of Toledo. Data will be collected and analyzed to determine the effectiveness of the treatment in comparison to the placebo, and results will contribute to the understanding of non-ablative RF treatments in menopausal health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized clinical trial with two parallel groups. Participants are randomly assigned to one of two groups: the treatment group receiving non-ablative monopolar radiofrequency and the placebo group receiving a sham procedure. The study includes six treatment sessions for each participant, with evaluations conducted at baseline, at the end of the treatment period, and three months post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Non-ablative monopolar radiofrequency treatment6 treatment sessions of non-ablative radiofrequency, with a frequency of 1 session per week. The following protocol will be followed: Preparation (5 minutes): Resistive monopolar electrode applied to vulvar area with gradual heating (sensation 4-5/10). Main Phase (10 minutes): Intracavitary capacitive electrode used to reach and maintain 41-43°C throughout the 10-minute application. Final Phase (5 minutes): Repeat resistive electrode application with subthermal effect (sensation 3-4/10). |
| Placebo Group | Sham comparator | Device: Non-ablative monopolar radiofrequency treatmentParticipants in this group will receive the same treatment protocol, but without the application of heat. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 65 years.
- Postmenopausal women (defined as no menstrual period for at least 12 months).
- Experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), such as vaginal dryness, irritation, or discomfort.
- Experiencing discomfort or complaints during vaginal penetration. Engaging in sexual activity (at least once a month).
- Willing to participate in the study and sign the informed consent form.
Key exclusion criteria (12 listed)
- Presenting with active vaginal infections.
- Presence of neurological, neoplastic, or sexually transmitted diseases.
- Presenting with vulvodynia or vaginismus.
- Prolapse grade 2 or higher.
- Presenting with altered sensitivity in the pelvic area.
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 |
|---|---|---|
| Non-ablative monopolar radiofrequency treatmentProtocol for the experimental group: Tissue preparation phase: 5 minutes with the circular resistive monopolar electrode, applying slow circular or semicircular movements in the perineal area. The temperature will be gradually increased based on the patient's temperature perception, ensuring it remains comfortable (approximately 5 out of 10). Main phase: 10 minutes using the intracavitary capacitive electrode connected to the PLUMA handle, lightly resting it on the tissues and continuously moving the electrode. The intravaginal temperature was maintained at 41-43°C throughout the 10-minute intracavitary application. Final phase: 5 minutes with the circular resistive monopolar electrode, applying it similarly to the preparatory phase, with a subthermal effect, reaching a self-reported thermal sensation of 3 to 4 out of 10. Participants in this group will receive the same treatment protocol, but with radiofrequency energy disabled. | Device | Placebo Group, Treatment Group |
Primary outcome
Change in Female Sexual Function Index (FSFI)
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Multidimensional questionnaire evaluates sexual function over the past 4 weeks. The total score ranges from 2.0 (severe dysfunction) to 36.0 (no dysfunction). Sexual dysfunction was defined as a score equal to or below 26.55
Change in Vaginal Health Index (VHI)
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
A tool that evaluates five parameters: vaginal elasticity, vaginal secretion (type and consistency), pH, mucosal epithelial integrity, and vaginal moisture. Each parameter was scored on a scale from 1 (most unfavorable condition) to 5 (optimal condition), with a maximum possible score of 25 points. In cases where the score was below 15, the vagina was considered atrophic.
17 secondary outcomes
Change in sexual desire
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual arousal
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual lubrication
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual orgasm
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual satisfaction
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual pain
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Elasticity
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal secretion
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal pH
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Ephitelial integrity
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in vaginal Moisture
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal Maturity Index
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Status Estrogen
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Vaginal Laxity Questionnaire (VLQ)
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Pain assessed by NRS
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in Urinary Symptoms by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: Baseline, end of treatment period (5 weeks), and three months post-treatment.
Change in Health- related quality of Life by SF-12
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 30104904Naumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. Int J Womens Health. 2018 Jul 31;10:387-395. doi: 10.2147/IJWH.S158913. eCollection 2018.
- Background: PubMed 32990054Potter N, Panay N. Vaginal lubricants and moisturizers: a review into use, efficacy, and safety. Climacteric. 2021 Feb;24(1):19-24. doi: 10.1080/13697137.2020.1820478. Epub 2020 Sep 29.
- Background: PubMed 35111272Wiegerinck AIP, Thomsen A, Hisdal J, Kalvoy H, Tronstad C. Electrical Impedance Plethysmography Versus Tonometry To Measure the Pulse Wave Velocity in Peripheral Arteries in Young Healthy Volunteers: a Pilot Study. J Electr Bioimpedance. 2021 Dec 30;12(1):169-177. doi: 10.2478/joeb-2021-0020. eCollection 2021 Jan.
- Background: PubMed 31145419Shifren JL, Crandall CJ, Manson JE. Menopausal Hormone Therapy. JAMA. 2019 Jun 25;321(24):2458-2459. doi: 10.1001/jama.2019.5346. No abstract available.
- Background: PubMed 15167829Roy S, Caillouette JC, Roy T, Faden JS. Vaginal pH is similar to follicle-stimulating hormone for menopause diagnosis. Am J Obstet Gynecol. 2004 May;190(5):1272-7. doi: 10.1016/j.ajog.2003.12.015.
- Backgroundundefined
- Background: PubMed 22011753Tan O, Bradshaw K, Carr BR. Management of vulvovaginal atrophy-related sexual dysfunction in postmenopausal women: an up-to-date review. Menopause. 2012 Jan;19(1):109-17. doi: 10.1097/gme.0b013e31821f92df.
- Background: PubMed 36304000Sarmento ACA, Costa APF, Vieira-Baptista P, Giraldo PC, Eleuterio J Jr, Goncalves AK. Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic. Front Reprod Health. 2021 Nov 15;3:779398. doi: 10.3389/frph.2021.779398. eCollection 2021.
- Background: PubMed 25841598Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Claudia Quezada Bascuñán, Ms principal investigator
University of Castilla-La Mancha
Asunción Ferri Morales, PhD study chair
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 Non-ablative monopolar radiofrequency treatment in people with Genitourinary Syndrome of Menopause and Vaginal Health, 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 5 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: finished, as of the sponsor's last update on 17 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Female Sexual Function Index (FSFI) (time frame: Baseline, end of treatment period (6 weeks), and three months post-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 NCT06925139, which also lists 9 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 17 Aug 2026.