Clinical trial NCT06925139: Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women
Official title: Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 58
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Female Sexual Function Index (FSFI)
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Vaginal Health Index (VHI)
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Secondary outcomes:
measure: Change in sexual desire
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in sexual arousal
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in sexual lubrication
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in sexual orgasm
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in sexual satisfaction
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in sexual pain
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in vaginal Elasticity
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Vaginal secretion
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in vaginal pH
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in vaginal Ephitelial integrity
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in vaginal Moisture
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Vaginal Maturity Index
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Status Estrogen
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Vaginal Laxity Questionnaire (VLQ)
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Pain assessed by NRS
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
measure: Change in Urinary Symptoms by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
timeFrame: Baseline, end of treatment period (5 weeks), and three months post-treatment.
measure: Change in Health- related quality of Life by SF-12
timeFrame: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: University of Castilla-La Mancha
Study officials:
affiliation: University of Castilla-La Mancha
name: Claudia Quezada Bascuñán, Ms
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Castilla-La Mancha
name: Asunción Ferri Morales, PhD
role: STUDY_CHAIR
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citation: undefined
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