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

Centro de Atenção ao Assoalho Pélvico

Status: Begins enrollment in 6 months

Conditions: Menopause; Urinary Incontinence

Treatments: Other: Pelvic floor muscle training; Device: Microablative Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT06336564

71168623.6.0000.5544

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Pelvic floor muscle training

Treatment:

Other: Pelvic floor muscle training

Intervention Group

Experimental group

Description:

Pelvic floor muscle training and microablative radiofrequency

Treatment:

Device: Microablative Radiofrequency

Other: Pelvic floor muscle training