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

Official title

Microablative Radiofrequency in the Treatment of Urinary Symptoms Associated With Genitourinary Syndrome of Menopause: Randomized Clinical Trial

Overview

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.

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 se
• 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 leng

Primary outcome measures

• Resolution or improvement of episodes of urinary loss assessed by pad test [Time frame: 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 [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.]

Secondary outcome measures (7)

• Recovery of vaginal health assessed by Vaginal Index Maturation [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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. [Time frame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment]
• Degree of patient satisfaction using a five-point Likert scale. [Time frame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment]
• Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS) [Time frame: Immediately after the initial physical examination and at the end of each of the three session (every 30 to 40 days).]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Centro de Atenção ao Assoalho Pelvico — Salvador

Identifiers

NCT: NCT06336564 · 71168623.6.0000.5544

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗