NCT02611791|CompletedPhase 2
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Sponsor study identifier
interventional
42
0 countries
N/A
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
June 2014
Actual (reported)OBJECTIVES: The aim of the study is to evaluate the clinical response of the non-ablative radiofrequency (RF) in the outcome cosmetic female external genital and its effect in the sexual function. METHODS: Single blind randomized controlled trial. Sample of 43 women (29 sexual active) with insatisfaction appearance of the external genitalia, 21 (14) in the study group and 22 (15) in the control group. The protocol consisted in 8 sessions of RF once a week. The instruments of evaluation were photo (taken before the first session and eight days after the last session), which were evaluated by the patient and by three health professional (that did not know the group); by the 3 points Likert scale (unsatisfied, unchanged, satisfied) and (worst, unchanged, improved). The sexual function was evaluated by the Female Sexual Function Index (FSFI) before and after, and analyzed by the T Test of Student. The patients' satisfaction and the health professionals' evaluation were analyzed by the chi-squared test and by binomial comparison inter-group and intra-group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2013
Actual (reported)June 2014
Actual (reported)November 4, 2015
Actual (reported)November 23, 2015
Actual (reported)clinical response
To evaluate the clinical response at radio frequencies of large labia region through the pictures before and after ( assessed by a physiotherapist , gynecologist and dermatologist ).
2 months
Patient satisfaction
Patient satisfaction: The response to treatment will be categorized in the absence of improvement; improvement or worsening .
2 months
Function Sexual
2 months
Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genitalia.
Eight RF sessions were performed, with an interval of seven days between them. The application of Radiofrequency in the external genital which was turned off, but a water-soluble gel was used
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.
Patricia V Lordelo, PhD
Centro de Atenção ao Assoalho Pélvico - BAHIANA
42 participants (actual enrollment reported by the registry).
First Submitted
November 4, 2015
First Posted
November 23, 2015
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis
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.
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Primary Completion
December 2013
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
November 23, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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