Radiofrequency Female External Genital Region: a Clinical Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

June 30, 2014

Conditions
Dissatisfaction Appearance of the External Genitalia
Interventions
DEVICE

Radiofrequency

The application of RF was through Tecatherap-VIP unit (VIP-Eletromedicina, Argentina) with bipolar method, using a gauntlet of 2cm, and the coupling electrode, which was located in the sacral region (fig x). For the application, participants were placed in a supine position with legs in lithotomy position, it was used water soluble gel for coupling and slide of the gauntlet. The application in external labia majora was made in the caudal-cranial direction, with constant movement and electrode lightly pressed. (fig) During the session, the heat level was monitored verbally and by infrared digital thermometer. The intensity was gradually increased, and at the time when the temperature reached values between 39-41ºC, the intensity was reduced two points and the procedure was maintained for two minutes.

DEVICE

Radiofrequency - OFF

The treatment protocol for the control group was identical, differing only in relation to the RF equipment, which was turned off, but a water-soluble gel was used, heated by a resistor, preventing the patient from knowing to which group she belonged. Just the physiotherapist who performed the procedure knew which group the patient belonged to.

All Listed Sponsors
lead

Centro de Atenção ao Assoalho Pélvico

OTHER

NCT02611791 - Radiofrequency Female External Genital Region: a Clinical Trial | Biotech Hunter | Biotech Hunter