An interventional study of Non-ablative monopolar radiofrequency treatment in Genitourinary Syndrome of Menopause, Vaginal Health and Sexual Dysfunction, sponsored by University of Castilla-La Mancha. Completed at 1 site in Spain. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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.
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.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Non-ablative monopolar radiofrequency treatment
Participants in this group will receive the same treatment protocol, but without the application of heat.
Device: Non-ablative monopolar radiofrequency treatment
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.
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
Time frame: 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.
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Change in sexual desire
Assessed by Female Sexual Function Index in individual domain of sexual desire. Score from 1,2 (worst) to 6 (best)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
It is a brief 4-item questionnaire designed to assess the frequency, severity, and impact of urinary incontinence on quality of life.
Time frame: 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.
Time frame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sexual Dysfunction, Physiological →
University of Castilla-La Mancha →