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

NCT06303609 | Recruiting

• 1 other identifier: 61102222.5.0000.5544
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

genito-pelvic pain disorder; radiofrequency; nonablative radiofrequency; women

Outcome Measures

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

  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 treatment

Secondary Outcomes (3)

• Sexual function

  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 treatment

• Quality of sexual life

  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 treatment

• Stress perception

  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 treatment

Study Arms (2)

Radiofrequency group

EXPERIMENTAL

Once a week, for 8 weeks, patient will undergo monopolar non-ablative radiofrequency application by a trained researcher.

Device: nonablative radiofrequency; Device: Vaginal dilator

Sham group

ACTIVE COMPARATOR

Once a week, for 8 weeks, patient will undergo monopolar non-ablative radiofrequency application by a trained researcher, but the radiofrequency device will not emit the radiofrequency wave.

Device: Vaginal dilator; Device: Sham nonablative radiofrequency

Interventions

nonablative radiofrequency DEVICE

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.

Radiofrequency group

Vaginal dilator DEVICE

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.

Radiofrequency group; Sham group

Sham nonablative radiofrequency DEVICE

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.

Sham group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with genito-pelvic pain disorder associated to penetration.

You may not qualify if:

• Chronic degenerative disease
• Cognitive impairment
• Genital agenesis
• History of vaginal cancer or genital radiotherapy
• Pelvic or lumbosacral prostheses
• Cardiac pacemakers
• Pregnant women
• Infections in the genital or systemic region
• Any type of treatment for genito-pelvic pain disorder
• Unstable relationship with the same partner
• Partner with sexual complaints.

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tuffy Mamede, Post-graduation

CONTACT

+5571999673967; tuffy@tuffymamede.com

Patrícia Lordelo, Ph.D

CONTACT

pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the CentroAAP

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: March 12, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

BR (1)