Status:
ACTIVE_NOT_RECRUITING
Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women
Lead Sponsor:
University of Castilla-La Mancha
Conditions:
Genitourinary Syndrome of Menopause
Vaginal Health
Eligibility:
FEMALE
40-65 years
Phase:
NA
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 d...
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 Syndrom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06925139
Start Date
April 15 2024
End Date
June 15 2025
Last Update
April 13 2025
Active Locations (1)
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1
University of Castilla-La Mancha
Toledo, Spain, 45000