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

Qualifiers

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

Treatments tested in this trial

  • nonablative radiofrequency
  • Vaginal dilator
  • Sham nonablative radiofrequency

Treatment groups

56 Participants
are divided into 2 treatment groups