Effect of the Radiofrequency and Pelvic Muscle Training in the Treatment of Women with Vaginal Laxity.

Not Applicable

Recruiting

• Conditions: Sexual Dysfunction, Physiological; C12.294.644

• Registration Number: RBR-2zdvfp
• Lead Sponsor: Faculdade de Ciência Médicas da Universidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Will be included women 18 years of age onwards and complaining of vaginal laxity assessed by the direct question and Vaginal Laxity Questionnaire, and willingness to participate in therapies at the dates and places scheduled for the proposed treatment.

Exclusion Criteria

Patients with decompensated cardiac and metabolic diseases, as well as pacemaker use; cognitive impairment; peripheral or central neurological disorders; presence of any cancer; presence of cervical dysplasia; history of active urinary or vaginal infection; presence of pelvic organ prolapse stage 2 onwards; patients undergoing physical therapy treatment with pelvic floor training; use of estrogen vaginally in the last 6 months; degree of force of contraction of the pelvic floor muscles equal to zero according to the Modified Oxford Scale and patients who have already undergone prolapse or sling correction surgery will be excluded.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of the pelvic floor support structures is expected through 3 sessions of vaginal microablative radiofrequency application over a 12 week treatment period. A subjective 7 point scale will be applied to answer the question: How are you feeling right now (vaginal looseness or tightness and sexual satisfaction) compared to starting treatment? 1 improved markedly, 2 improved moderately, 3 improved slightly, 4 no change, 5 slightly worse, 6 moderately worse, 7 much worse.;Improvement of the pelvic floor support structures is expected through 12 training sessions of the pelvic floor muscles with daily home care increment over a 12-week treatment period. A subjective 7 point scale will be applied to answer the question: How are you feeling now (levels of looseness or vaginal tightness and sexual satisfaction) compared to the start of treatment? 1 has improved markedly, 2 has improved moderately, 3 has improved slightly, 4 no change, 5 slightly worse, 6 moderately worse, 7 much worse.