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

NCT06336564 | Not Yet Recruiting

• 1 other identifier: 71168623.6.0000.5544
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Genitourinary Syndrome fo Menopause (GSM) is made up of a set of changes in the region of the vulva, vagina and lower urinary tract associated with a decrease in estrogen levels in the urogenital tissue, which leads to a reduction in blood supply, disorders in collagen metabolism and skin elasticity. The standard treatment for urinary incontinence during menopause is pelvic floor muscle training, associated or not with local hormone replacement therapy. Although low cost and easy to access, it is associated with low patient's adherence. Physical methods such as laser and radiofrequency in non-ablative, ablative and microablative forms are technologies that have recently been used in the vaginal mucosa to promote neoelastogenesis and neocollagenesis. It is hypothesized that menopausal women, who present symptoms of GSM, may benefit from this new, minimally invasive resource (microablative radiofrequency). This is a randomized clinical trial in which women aged between 40 and 65 years old will be included with clinical complaints of urinary symptoms associated with GSM. A basic anamnestic questionnaire will be used as the study instrument to collect sociodemographic, clinical data and symptoms, following the routine and standard of the service. To evaluate the treatment, the following will be used: voiding diary, pad test, vaginal cytology, histopathology, Female Sexual Function Index (FSFI), Short-Form Health Survey - SF-36 Questionnaire, King's Health Questionnaire, evolution of symptoms (dryness, pain during sexual activity, vaginal laxity, itching, burning sensation and pain in the vaginal introitus) and level of patient's satisfaction. Patients will be randomized into: group 1 or control group, which will perform pelvic floor muscle training, PFMT, with supervision (three times) and at home twice a day, and group 2 or test group, which will perform the same PFMT protocol associated with vaginal microablative radiofrequency. 10% lidocaine spray will be applied three minutes before the procedure and three applications will be made to the vagina/vaginal introitus, with an interval of 30 to 40 days. The purpose of this study is to test the efficacy and duration of effect of microablative radiofrequency in the treatment of urinary symptoms associated with GSM.

Conditions

Menopause; Urinary Incontinence

Keywords

Genitourinary syndrome of menopause; Microablative Radiofrequency

Outcome Measures

Primary Outcomes (5)

• Resolution or improvement of episodes of urinary loss assessed by pad test

  Participants will perform the one-hour Pad Test to diagnose and quantify urinary loss. Initially, the absorbent will be placed in a closed plastic bag and weighed on a precision electronic scale (Denver Instrument®). Then, the participant will be instructed to put on the pad, drink 500 ml of water in a maximum of 15 minutes and remain at rest for another 15 minutes, this phase represents 30 minutes of the test. In the other 30 minutes, the participant will be asked to perform certain standardized activities simulating activities of daily life (going up and down stairs, sitting down and standing up ten times, coughing ten times, picking up objects from the floor five times, running in the same place for one minute and washing the hands under running water for one minute).

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.

• Resolution or improvement of episodes of urinary loss assessed by urinary diary

  Participants will be instructed to keep a voiding diary at home for three days to record water intake, urinary volume and the number of incontinence episodes, as well as episodes of urgency and nocturnal enuresis.

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

• Number of patients with tolerability related to treatment assessed by Likert Scale.

  Likert scale of 3 points will be asked to the patients: 1) impossible to tolerate the treatment, 2) not nice, but possible to tolerate, 3) very tolerable.

  At each of the three sessions (every 30 to 40 days), 30 days after the end of treatment and 12 months after the end of the treatment.

• Number of patients with adverse effects related to treatment assessed by histopathology.

  To evaluate the safety in tissue effect of FRAXX, samples of vaginal tissue will be obtained through a biopsy taken from the lateral walls, in the middle third of the vagina, for histopathological study. Procedure carried out under colposcopic vision, using a 3mm loop attached to the radiofrequency device, "surgery" mode, removing a small vaginal fragment.

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.

• Resolution or improvement of episodes of urinary loss assessed by questionnaire.

  The questionnaire to be used will be International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) which is a self-administered questionnaire that assesses the impact of UI on quality of life and the classification of urinary loss. The ICIQ-SF is composed of four questions that assess the frequency, severity and impact of UI, in addition to a set of eight self-diagnosis items, related to the causes or situations of UI experienced by patients. The higher the score, the greater the severity of urinary incontinence and the greater the impact on the patient's quality of life.

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.

Secondary Outcomes (7)

• Recovery of vaginal health assessed by Vaginal Index Maturation

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

• Recovery of vaginal health assessed by vaginal pH

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

• Improvement of Sexual Function assessed by Female Sexual Function Index

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

• Improvement of quality of life assessed by Short-Form Health Survey (SF-36)

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

• Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire.

  Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Pelvic floor muscle training

Other: Pelvic floor muscle training

Intervention Group

EXPERIMENTAL

Pelvic floor muscle training and microablative radiofrequency

Other: Pelvic floor muscle training; Device: Microablative Radiofrequency

Interventions

Pelvic floor muscle training OTHER

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.

Control Group; Intervention Group

Microablative Radiofrequency DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical complaint of urinary incontinence associated to Genitourinary Syndrome of Menopause.
• Negative cervical oncotic cytology, within the last 3 years.

You may not qualify if:

• Patients with cognitive deficit;
• Patients with chronic degenerative neurological diseases;
• Post-void residue greater than 50 ml;
• Carriers of a pacemaker and implantable cardioverter defibrillator;
• Use of hormonal therapy (topical or systemic) starting in the 2 months prior to the initial assessment;
• Patients undergoing brachytherapy or pelvic radiotherapy;
• Patients that had reconstructive pelvic surgery;
• Pregnant women.

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

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrícia Lordelo, PhD

  Pelvic Floor Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia V Lordelo, PhD

CONTACT

+5571996592400; pvslordelo@hotmail.com

Study Design

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

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)