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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Placebo Group | Sham Comparator | Participants in this group will receive the same treatment protocol, but without the application of heat. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified females who are biologically female and postmenopausal.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Quezada Bascuñán, Ms | University of Castilla-La Mancha | Principal Investigator |
| Asunción Ferri Morales, PhD | University of Castilla-La Mancha | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Castilla-La Mancha | Toledo | 45000 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104904 | Background | 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. | |
| 32990054 | 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. |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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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.
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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. |
| 35111272 | 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. |
| 31145419 | 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. |
| 15167829 | 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. |
| Background | undefined |
| 22011753 | 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. |
| 36304000 | 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. |
| 25841598 | Background | Takahashi TA, Johnson KM. Menopause. Med Clin North Am. 2015 May;99(3):521-34. doi: 10.1016/j.mcna.2015.01.006. |