Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2027

Conditions
MenopauseUrinary Incontinence
Interventions
OTHER

Pelvic floor muscle training

"Verbal information will be given about location, function and the correct way to contract the pelvic floor muscles (PFM). Participants will be instructed on how to perform The Knack, which is a pre-contraction of the PFM during some abdominal effort, such as coughing, sneezing or laughing. The exercises consist of two series of 10 maximum contractions sustained for 5 seconds and 10 seconds of relaxation and two series of 10 maximum rapid contractions with two seconds of maintenance and four seconds of relaxation, with one minute of rest between each series. Participants will be instructed to perform the same exercises at home (twice a day) and to fill out a training diary, allowing researchers to monitor and check whether the exercises are actually being performed. The protocol will be repeated with the researcher three times in total, every 30 to 40 days."

DEVICE

Microablative Radiofrequency

Patients will be placed in the lithotomy position and through speculum examination and under direct vision or guided by colposcope, sequential application of radiofrequency will be carried out on the vaginal walls and introitus. The Wavetronic 6000 Touch device will be used with the Megapulse HF FRAXX system (Loktal Medical Electronics, São Paulo, Brazil), equipped with an electronic energy fractionation circuit, connected to a vaginal pen with 64 microneedles, 200μm in diameter and 1 mm in length, mounted on a Teflon body and divided into a matrix of eight columns with eight needles each. In the vestibule and vaginal opening, 10% lidocaine spray will be applied three minutes before the procedure. Three applications will be carried out in the vagina/vaginal introitus, with an interval of 30 to 40 days.

Trial Locations (1)

40.290-000

Centro de Atenção ao Assoalho Pelvico, Salvador

All Listed Sponsors
lead

Centro de Atenção ao Assoalho Pélvico

OTHER

NCT06336564 - Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause | Biotech Hunter | Biotech Hunter