Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: In this study, transvaginal radiofrequency will be applied for the treatment of urinary incontinence in women. They will be subject to two groups (intervention group and control group). A total of 86 women will be evaluated, 43 for the intervention group and 43 for the control group. GROUP CONTROL: The device used for radiofrequency application will be the Spectra Medic, of the Brazilian brand Tonederm, released by the National Health Surveillance Agency (ANVISA) through registration number 10411520022. The transducer used will be the only company. A participant is positioned in the gynecological position, and will be introduced into the transducer vaginally with a condom. The control group receives the device via vaginal OFF. During the session, 4 minutes will be performed in each quadrant of the vagina (anterior, posterior, right and left sides). Right after, Start or attendance with a physiotherapy session. They will perform the muscle contraction 15 times in the lying position, 15 times in the sitting position and 15 times in the standing position, always supervised by the physiotherapist. The treatment will last an average of 20 minutes, totaling everything. Three sessions will be held, with an interval of 1 month, during the period of 3 months. INTERVENTION GROUP: The device used for radiofrequency application will be the Spectra Medic, of the Brazilian brand Tonederm, released by the National Health Surveillance Agency (ANVISA) through registration number 10411520022. The transducer used will be the only company. A participant is positioned in the gynecological position, and will be introduced into the transducer vaginally with a condom. The control group receives the device via vaginal ON at a temperature of 45 degrees. During the session, 4 minu Procedure/surgery Radio Waves CONDITION: Urinary Incontinence Urinary incontinence ; Urinary Incontinence PRIMARY OUTCOME: The use of the transvaginal radiofrequency technique, associated with the pelvic muscle strengthening exercise, is more effective in relation to the pelvic muscle strengthening exercise alone in the treatment of postmenopausal women with urinary incontinence.; Verified through the quality of life questionnaire called International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF), sexual questionnaire called Sexual Satisfaction The Female Sexual Function Index (FSFI) and voiding diary.; Qualitative variables will be described using absolute and relative frequency and quantitative variables using mean and standard deviation.; To assess the interaction between moment and group in the quantitative variables, the Generalized Estimation Equations (GHG) will be used. The association between qualitative variables and group will be through the chi‐square test. Values ??of p <0.05 will be considered significant and the analyzes will be performed using the SPSS Software. SECONDARY OUTCOME: The use of the transvaginal radiofrequency technique, associated with the pelvic muscle strengthening exercise, is no longer effective in relation to the pelvic muscle strengthening exercise alone in the treatment of postmenopausal women with urinary incontinence. ; Verified through the quality of life questionnaire called International Consultation on Incontinence Questionnaire ‐ Short Form (ICIQ‐SF), sexual questionnaire called Sexual Satisfaction The Female Sexual Function Index (FSFI) and voiding diary. ; Qualitative variables will be described using absolute and relative frequency and quantitative variables using mean and standard deviation. ; To assess the interaction between moment and group in the quantitative variables, the Generalized Estimation Equations (GHG) will be used. The association between qualitative variables and group will be through the chi‐square test. Values ??of p <0.05 will be considered significant and the analyzes will be performed using the SPSS Software. INCLUSION CRITERIA: Women from the PUC gynecology outpatient clinic who are post menopausal, with a diagnosis of stress urinary incontinence or mixed stress urinary incontinence will be included, who have no urinary infection on urine examination and want to participate in the study.
Epistemonikos ID: 53bd22bf06248587e1d6516d3269ca92c43e1eb9
First added on: Aug 24, 2024