Use of Radiofrequency Energy in the vulvovaginal region for the treatment of women with Urogenital symptoms present in Menopause and who have previously undergone radiotherapy

Evaluation of the use of vulvovaginal Microablative Fractional Radiofrequency (MAFRF) in women with Genitourinary Syndrome of Menopause and previously submitted to pelvic radiotherapy and or brachytherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-3tq63qk

Enrollment

Unknown

Registered

2024-11-14

Start date

2017-08-17

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-inflammatory disorders of the vagina

Interventions

This is a prospective cohort study, with the objective of evaluating the use of vulvo-vaginal Microabaltive Radiofrequency (RFFMA) in climacteric patients with menopausal genitourinary syndrome and wh

N95.8

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Menopausal patients who had undergone pelvic radiotherapy or brachytherapy, complaining of menopausal urogenital syndrome; Pap smear test negative for neoplasia, within the routine deadline recommended by the Ministry of Health/INCA; without active genital hormone therapy

Exclusion criteria

Exclusion criteria: Use of estrogenic and or androgenic hormone therapy in the last sixty days; adverse anatomical conditions; users of pacemakers or internal defibrillators or any other active electrical implant; permanent implant in the treated area, such as polypropylene meshes; severe decompensated clinical conditions (such as cardiac dysfunctions; active systemic collagenoses; confirmed or presumed immunodeficiencies)

Design outcomes

Primary

Measure	Time frame
The main expected outcome is the improvement of symptoms after application of radiofrequency procedures. To this end, questionnaires answered after each procedure were observed and correlated with histological findings from vaginal biopsies performed before and after the procedures in patients with Menopausal genitourinary syndrome, who had received previous radiotherapy and/or pelvic brachytherapy	—

Measure

Time frame

The main expected outcome is the improvement of symptoms after application of radiofrequency procedures. To this end, questionnaires answered after each procedure were observed and correlated with histological findings from vaginal biopsies performed before and after the procedures in patients with Menopausal genitourinary syndrome, who had received previous radiotherapy and/or pelvic brachytherapy

—

Secondary

Measure	Time frame
Evaluate histological changes using stains such as Hematoxelin Eosin; Picrosirius Red and Masson's Trichrome, observing changes in the lamina propria with neovascularization and neocollagenesis and hypertrophy of the vaginal mucosa epithelium	—

Countries

Brazil

Contacts

Public ContactJosé Soares

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

jsoares415@hotmail.com+55 (11) 26617178

Outcome results

None listed

Source: REBEC (via WHO ICTRP)