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Background: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. Aim: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. Methods: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. Outcomes: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. Results: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference −0.08 [95% confidence interval, −2.58 to 2.42]) in the per-protocol analysis (mean difference −0.46 [95% confidence interval, −2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. Clinical Implications: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. Strengths & Limitations: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. Conclusion: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment. [ABSTRACT FROM AUTHOR]

Objective: We aimed to translate and determine cultural validity of the Vaginal Changes Sexual and Body Esteem Scale (VSBE) for Brazilian Portuguese language in postpartum women who underwent vaginal delivery with or without perineal laceration and cesarean section., Methods: A cross-sectional study conducted virtually, with online data collection through a survey with 234 postpartum women of 975 that were invited. Clinical, sociodemographic, and psychometric variables from the VSBE questionnaire were analyzed (content validity index, internal consistency, test-retest reliability, construct/structural and discriminant validity). Multivariate analysis was performed to explore associated factors with the presence of perineal laceration., Results: One-hundred fifty-eight women experienced vaginal delivery, of which 24.79% had an intact perineum, 33.33% had perineal laceration, and 9.4% underwent episiotomy; and 76 participants had cesarean sections. Women with perineal laceration were older, presented dyspareunia and previous surgeries than women without perineal laceration (p<0.05). For VSBE, a high internal consistency (Cronbach's α > 0.7) was observed, but it did not correlate with Body Attractiveness Questionnaire and Female Sexual Function Index; however, it correlated with the presence of women sutured for perineal laceration. Moreover, VSBE presented good structural validity with two loading factors after exploratory factor analysis. VSBE also demonstrated discriminant validity between the presence or absence of perineal laceration. The presence of urinary incontinence (UI) (OR=2.716[1.015-4.667];p=0.046) and a higher VSBE total score (OR=1.056[1.037-1.075];p<0.001) were the only factors associated with perineal laceration., Conclusion: Vaginal Changes Sexual and Body Esteem Scale demonstrated appropriate translation and good internal consistency, discriminant/construct validity and reliability. Vaginal Changes Sexual and Body Esteem Scale total score and presence of UI were associated with women that underwent perineal laceration., Competing Interests: Conflicts to interest: none to declare., (© 2023. Federação Brasileira de Ginecologia e Obstetrícia. All rights reserved.)