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

NCT06925139 | Active Not Recruiting

• 1 other identifier: MEN_RF_01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Genitourinary Syndrome of Menopause; Vaginal Health; Sexual Dysfunction

Keywords

Non-ablative radiofrequency; Vaginal Health; Sexual Health; Postmenopause; Genitourinary Syndrome of Menopause; Sexual Dysfunction; Women's Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Change in sexual desire

  Baseline, end of treatment period (6 weeks), and three months post-treatment.

• Change in sexual arousal

  Baseline, end of treatment period (6 weeks), and three months post-treatment.

• Change in sexual lubrication

  Baseline, end of treatment period (6 weeks), and three months post-treatment.

• Change in sexual orgasm

  Baseline, end of treatment period (6 weeks), and three months post-treatment.

• Change in sexual satisfaction

  Baseline, end of treatment period (6 weeks), and three months post-treatment.

Study Arms (2)

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 (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

Placebo Group

SHAM COMPARATOR

Participants in this group will receive the same treatment protocol, but without the application of heat.

Device: Non-ablative monopolar radiofrequency treatment

Interventions

Non-ablative monopolar radiofrequency treatment DEVICE

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.

Placebo Group; Treatment Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Self-identified females who are biologically female and postmenopausal.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha

Toledo, 45000, Spain

Location

Related Publications (9)

• 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.

  PMID: 30104904 BACKGROUND

• 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.

  PMID: 32990054 BACKGROUND

• 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.

  PMID: 35111272 BACKGROUND

• 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.

  PMID: 31145419 BACKGROUND

• 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.

  PMID: 15167829 BACKGROUND

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  BACKGROUND

• 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.

  PMID: 22011753 BACKGROUND

• 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.

  PMID: 36304000 BACKGROUND

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

  PMID: 25841598 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Claudia Quezada Bascuñán, Ms

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

• Asunción Ferri Morales, PhD

  University of Castilla-La Mancha

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind, randomized clinical trial, participants, investigators analyzing the results, and outcomes assessors are all blinded to the group assignments. This ensures unbiased administration of treatments, unbiased data collection, and unbiased assessment of both primary and secondary outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a double-blind, 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. Both participants and researchers are blinded to group assignments to ensure unbiased results. 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.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: April 13, 2025
• Study Start: April 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 15, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)