Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women
NCT ID: NCT06925139
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
58 participants
INTERVENTIONAL
2024-04-15
2025-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
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.
Placebo Group
Participants in this group will receive the same treatment protocol, but without the application of heat.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
65 Years
FEMALE
No
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Claudia Quezada Bascuñán, Ms
Role: PRINCIPAL_INVESTIGATOR
University of Castilla-La Mancha
Asunción Ferri Morales, PhD
Role: STUDY_CHAIR
University of Castilla-La Mancha
Locations
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University of Castilla-La Mancha
Toledo, , Spain
Countries
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References
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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.
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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.
Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006.
Other Identifiers
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MEN_RF_01
Identifier Type: -
Identifier Source: org_study_id
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