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

Not Applicable

Not yet recruiting

• Conditions: Menopause; Urinary Incontinence

• Registration Number: NCT06336564
• Lead Sponsor: Centro de Atenção ao Assoalho Pélvico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> - Clinical complaint of urinary incontinence associated to Genitourinary Syndrome of<br> Menopause.<br><br> - Negative cervical oncotic cytology, within the last 3 years.<br><br>Exclusion Criteria:<br><br> - Patients with cognitive deficit;<br><br> - Patients with chronic degenerative neurological diseases;<br><br> - Post-void residue greater than 50 ml;<br><br> - Carriers of a pacemaker and implantable cardioverter defibrillator;<br><br> - Use of hormonal therapy (topical or systemic) starting in the 2 months prior to the<br> initial assessment;<br><br> - Patients undergoing brachytherapy or pelvic radiotherapy;<br><br> - Patients that had reconstructive pelvic surgery;<br><br> - Pregnant women.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse effects related to treatment assessed by histopathology.;Resolution or improvement of episodes of urinary loss assessed by questionnaire.;Resolution or improvement of episodes of urinary loss assessed by pad test;Resolution or improvement of episodes of urinary loss assessed by urinary diary;Number of patients with tolerability related to treatment assessed by Likert Scale.

Secondary Outcome Measures

Name	Time	Method
Recovery of vaginal health assessed by Vaginal Index Maturation;Recovery of vaginal health assessed by vaginal pH;Improvement of Sexual Function assessed by Female Sexual Function Index;Improvement of quality of life assessed by Short-Form Health Survey (SF-36);Improvement or resolution of urinary incontinence and the impact on quality of life assessed by King's Health Questionnaire.;Degree of patient satisfaction using a five-point Likert scale.;Evolution of vaginal symptoms assessed by Visual Analogue Scale (VAS)