Authors
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Universidade Federal do Rio Grande do Norte -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: Device Needles Placebo Effect Radiofrequency Therapy This research will evaluate the long‐term effects of radiofrequency and microneedling on vulval sagging and sexual function in premenopausal women. The study is characterized as a prospective randomized blinded clinical trial. The sample will consist of 30 volunteers, which will be divided into 3 groups, radiofrequency group (GR), microagulch group (GM) and the control group (CG) and pre‐evaluated. and after treatment by means of evaluation protocols and questionnaires. There will be 8 weekly sessions, in the GR the parameters used will be frequency 2.4 MHz, temperature 40 ° C, application time 15 min, in the GM group will be micro‐needled with a Dr. Roller® roller® until hyperemia, In the control group treatment, the radiofrequency device will be turned off and the water soluble gel will be heated by a resistor. The reevaluations will be done four times to analyze the maintenance of the results. The study took place on the premises of the office Dr. Eneida Carreiro in the city of Natal/RN. It is expected to find a significant improvement in sagging, with improved appearance of the intimate aesthetics in the treated region and sexual function. CONDITION: Climacteric N00‐N99 Other noninflammatory disorders of vagina Climacteric ; Climacteric ; Other noninflammatory disorders of vagina Other noninflammatory disorders of vagina PRIMARY OUTCOME: Changes in vaginal sagging; through the Vaginal Laxity Questionnaire (VLQ) and photographs after 10 days, 01 month, 03 months, 06 months; on the basis of a change of at least 5% in changes during revaluations. Improvement in sexual function and quality of life; using the Female Sexual Function Index (FSFI) after 10 days, 01 month, 03 months, 06 months; based on a variation of at least 5% in the scores during the revaluations. SECONDARY OUTCOME: There will be no secondary outcomes. INCLUSION CRITERIA: In the inclusion criteria, participants should be between 40 and 55 years old, presenting flaccidity in the vulvar region, premenopausal period, who had at least one normal delivery, the last being at least 1 year, cell cytology normal, vaginal canal, introitus and vestibule free from injury and bleeding and with preserved comprehension and local sensitivity.
Epistemonikos ID: 7f6b4ebdfdf91bd444095a4133e39eed18016705
First added on: Aug 24, 2024