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

University of Castilla-La Mancha

Status: Active, not recruiting

Conditions: Sexual Dysfunction; Genitourinary Syndrome of Menopause; Vaginal Health

Treatments: Device: Non-ablative monopolar radiofrequency treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06925139

MEN_RF_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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).

Treatment:

Device: Non-ablative monopolar radiofrequency treatment

Placebo Group

Sham Comparator group

Description:

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

Treatment:

Device: Non-ablative monopolar radiofrequency treatment