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Efficacy of fractional Radiofrequency Microablation in the treatment of vaginal dryness, burning and itching of women with Breast Cancer: a randomized trial

Efficacy of Fractionated Radiofrequency Micro Ablation in the treatment of Genito-Urinary Syndrome in women with Breast Cancer: randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-78mt53
Enrollment
Unknown
Registered
2020-02-19
Start date
2019-11-10
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

Genitourinary menopause syndrome

Interventions

-Group 1 –30 participants.Three vaginal fractional radiofrequency (MARF) microablation sessions using the Wavetronic 6000 Touch device with the Megapulse HF FRAXX system (Loktal Medical Electronics, S
Drug
Other
D27.720.556
E02.808

Sponsors

Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Antecedente pessoal de câncer de mama;apresentar ressecamento vaginal associada ou não a dispareunia, ardência ou prurido vaginal;menopausa fisiológica com tempo de amenorreia superior a doze meses.

Exclusion criteria

Exclusion criteria: Current chemotherapy treatment for breast cancer; pacemaker use; presence of genital prolapses; decompensated heart disease; cognitive impairment; peripheral or central neurological disorders; presence of any other cancer; presence of cervical dysplasia; urinary or vaginal infection active; decompensated metabolic diseases; patients currently in use or within the last six months of some vaginal therapy; positive serology for HIV, hepatitis bece genital condylomatosis; previous pelvic radiotherapy; previous surgery on the vagina.

Design outcomes

Primary

MeasureTime frame
Primary outcome: Score above 15 by the Vaginal Health Index (VHI) that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use.—

Secondary

MeasureTime frame
Secondary outcome: Score above 65 by calculating the vaginal maturation index (MV) or Meisels index that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use. ;Secondary outcome: Score above 26 by the FSFI (Sexual Function Index) questionnaire that will be applied 30 days after the last radiofrequency session and 12 weeks after the start of vaginal moisturizer use.—

Countries

Brazil

Contacts

Public ContactThamara Heloisa Rizzi Donato Thamara Donato

Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM

thamaradonato@gmail.com+5519986030000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)