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

Summary

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.

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.

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-20

Primary Completion

2026-06-20

Completion

2026-07-20

Countries

• Brazil

Study Locations