NCT03506594

Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Centro de Atenção ao Assoalho Pélvico · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	Radiofrequency non ablative	The application of RF was performed by physical therapist trained in the technique of radiofrequency through the CAPENERGY device with capacitive transfer method using non-ablative handle with active electrode placed intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer and when it reached 41°C radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.

Timeline

• Start date: 2018-04-01
• Primary completion: 2025-12-01
• Completion: 2026-06-20
• First posted: 2018-04-24
• Last updated: 2024-05-29

Locations

1 site across 1 country: Brazil