Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder
ConditionPelvic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorCentro de Atenção ao Assoalho Pélvico
About this trial
The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with genito-pelvic pain disorder associated to penetration.
Disqualifiers
Chronic degenerative disease
Cognitive impairment
Genital agenesis
History of vaginal cancer or genital radiotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
nonablative radiofrequency
DeviceThe 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.
Vaginal dilator
DeviceBoth 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.
Sham nonablative radiofrequency
DeviceThe 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Radiofrequency groupExperimental treatment 2 interventions
Group B: Sham groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Penetration capacity with reduced vaginal pain
To assess the primary outcome it will be used the Visual Analogue Scale (VAS) related to pain during vaginal penile penetration and during the vaginal dilatator penetration. The score varies from 0 (no pain) to 10 (maximum pain). Diminishing at least 2 points on the scale means positive diffence with the treatment. Also the change of the size of the vaginal dilatator will be a measure to positive response to the treatment. There are 6 sizes: green nº 1: diameter 1.16cm, length 6.5cm; rose nº 2: diameter 1.90cm, length 7.5cm; yellow nº 3: diameter 2.15cm, length 8.7cm; purple nº 4: diameter 2.5cm, length 10.9cm; blue nº 5: diameter 3.10cm, length 13.20cm; and orange nº 6: diameter 3.5cm, length 14.5cm
Time frame
From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatmentSecondary outcomes
1
Sexual function
To measure the change in the sexual function it will be use the Female Sexual Function Index. It consists of 19 items and the score varies from 2 to 36. A score below or equal to 26 indicates sexual dysfunction.
Time frame
From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment2
Quality of sexual life
To measure the change in quality of sexual life it will be used the Scale of Female Sexual Quality of Life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
Time frame
From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatment3
Stress perception
To measure the stress perception it will be used the Stress Perception Scale - 10. There are 10 items and the total score can range from 0 to 40. The higher scores indicate higher levels of perceived stress.
Time frame
From enrollment till 6 months after the end of treatment: at the assessment, before each session (8 sessions, one per week), one week after the last session, one, three and six months after the end of the treatmentSponsors and contacts
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Source ClinicalTrials.gov