Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder

NARecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 20, 2024

Primary Completion Date

June 20, 2026

Study Completion Date

July 20, 2026

Conditions
Pelvic Pain
Interventions
DEVICE

nonablative radiofrequency

The active electrode from the nonablative radiofrequency will be applied to the urogenital- and uroanal trigone and the dispersive electrode will be attached to the back of the patient. The water-soluble gel will be applied to the active electrode and to the non-lubricated condom which will involve the electrode. There will be a gradual increase in temperature, monitored by a digital infrared thermometer, to reach temperature between 36°C and 38°C, keeping the movement for two minutes in each area, spending in total around 10 minutes.

DEVICE

Vaginal dilator

Both groups will use the vaginal dilator at the end of each session for 15 minutes and all patients will be advised to use it for 15 minutes daily in a home based treatment.

DEVICE

Sham nonablative radiofrequency

The active electrode from the nonablative radiofrequency will be applied to the urogenital- and uroanal trigone and the dispersive electrode will be attached to the back of the patient. The water-soluble gel will be applied to the active electrode and to the non-lubricated condom which will involve the active electrode. As the device will not deliver the radiofrequency wave, the gel will be heated so the patient has the feeling of the temperature change, keeping the movement for two minutes in each area, spending in total around 10 minutes.

Trial Locations (1)

40.290-000

RECRUITING

Centro de Atenção ao Assoalho Pelvico, Salvador

All Listed Sponsors
lead

Centro de Atenção ao Assoalho Pélvico

OTHER