Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women

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 double-blind, randomized clinical trial. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sexual Dysfunction; Vaginal Health; Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: Non-ablative monopolar radiofrequency 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 double-blind, 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.

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 and quality of life.

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 Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45000
    • University of Castilla-La Mancha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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 (15 minutes): Intracavitary capacitive electrode used to reach and maintain 40-42°C for at least 10 minutes. Final Phase (5 minutes): Repeat resistive electrode application with subthermal effect (sensation 3-4/10).	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 temperature should reach 40-42°C in the tissue and be maintained for at least 10 minutes. 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. Protocol for the sham group: this group will receive the same treatment protocol that treatment group, but without the application of heat.
Sham Comparator: Placebo Group; 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 temperature should reach 40-42°C in the tissue and be maintained for at least 10 minutes. 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. Protocol for the sham group: this group will receive the same treatment protocol that treatment group, but without the application of heat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, end of treatment period (6 weeks), and three months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sexual desire	Assessed by Female Sexual Function Index in individual domain of sexual desire. Score from 1,2 (worst) to 6 (best)	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)	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)	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)	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)	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).	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)	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)	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)	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)	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)	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.	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).	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.	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.	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.	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.	Baseline, end of treatment period (6 weeks), and three months post-treatment.

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Investigators: Principal Investigator: Claudia Quezada Bascuñán, Ms, University of Castilla-La Mancha; Study Chair: Asunción Ferri Morales, PhD, University of Castilla-La Mancha

Publications and helpful links

General Publications

• Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
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• 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.
• Potter 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.
• Wiegerinck 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.
• Shifren 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.
• Roy 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.
• 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.
• Sarmento 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Women's Health; Postmenopause; Sexual Health; Genitourinary Syndrome of Menopause; Sexual Dysfunction; Vaginal Health; Non-ablative radiofrequency
• Other Study ID Numbers: MEN_RF_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No