Clinical trial NCT06336564: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Urinary Incontinence
Keywords: Genitourinary syndrome of menopause
Microablative Radiofrequency
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Resolution or improvement of episodes of urinary loss assessed by pad test
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
measure: Resolution or improvement of episodes of urinary loss assessed by urinary diary
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Number of patients with tolerability related to treatment assessed by Likert Scale.
timeFrame: 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.
measure: Number of patients with adverse effects related to treatment assessed by histopathology.
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
measure: Resolution or improvement of episodes of urinary loss assessed by questionnaire.
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment.
Secondary outcomes:
measure: Recovery of vaginal health assessed by Vaginal Index Maturation
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Recovery of vaginal health assessed by vaginal pH
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Improvement of Sexual Function assessed by Female Sexual Function Index
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Improvement of quality of life assessed by Short-Form Health Survey (SF-36)
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire.
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Degree of patient satisfaction using a five-point Likert scale.
timeFrame: Before the beginning of the treatment, 30 days after the end of treatment and 12 months after the end of the treatment
measure: Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS)
timeFrame: Immediately after the initial physical examination and at the end of each of the three session (every 30 to 40 days).
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
affiliation: Pelvic Floor Care Center
name: Patrícia Lordelo, PhD
role: PRINCIPAL_INVESTIGATOR
References: