Experiences of women with symptoms of vaginal laxity - a qualitative study.

BACKGROUND: Vaginal laxity (VL) is rarely discussed among patients and their physicians possibly due to the lack of evidence-based treatments, embarrassment, and lack of knowledge in recognizing this condition. We aimed to understand the meanings that women attribute to the sensation of VL. METHODS: This is a qualitative study using in-depth interviews and thematic analysis. Sixteen participants were intentionally selected from February 2020 to December 2021. One researcher interviewed each participant in a private room guaranteeing that rapport was established. Two independent researchers performed a complete transcript of each interview immediately after its end. The sample size was achieved according to the Information Power analysis. We followed the thematic analysis proposed by Braun and Clarke. RESULTS: Of 16 patients, only one did not undergo delivery. Her complaint was not different from the rest of the group. Five major themes and subthemes were identified: the long and lonely pathway: from the identification of symptoms of VL to diagnosis (from the invisibility of VL to the perception of their symptoms; "everything will fall out!":shame, guilt and stigma as diagnosis barriers and "but I had no idea of looking for a treatment." Women's strategies to begin a help-seeking process), "the label of vaginal laxity is a heavy burden to bear" meanings associated with VL complaints, effect of VL on sexual intercourse and "I know it changed everything!" relationship with the partner. CONCLUSION: VL is a symptom that is still little understood by women, and little explored by health professionals, with repercussions on personal and marital life.

Validation and cultural translation for the Brazilian Portuguese version of the Estro-Androgenic- Symptom Questionnaire in Women.

Objective: This study aimed to translate and validate the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese language, as we hypothesized that this tool would be consistent for addressing the specific context of hormonal symptoms in menopause. Methods: In a cross-sectional study, a total of 119 women with Genitourinary Syndrome of Menopause (GSM) and 119 climacteric women without GSM were included. The EASQ-W was translated, and its psychometric properties were rigorously examined. Participants completed questionnaires covering sociodemographic details, the EASQ-W, and the Menopause Rating Scale (MRS). A subgroup of 173 women was re-invited after 4 weeks for test-retest analysis of the EASQ-W. Additionally, the responsiveness of the questionnaire was evaluated in 30 women who underwent oral hormonal treatment. Results: The internal consistency of the EASQ-W was found to be satisfactory in both GSM and control groups (Cronbach's alpha ≥ 0.70). Notably, a floor effect was observed in both groups; however, a ceiling effect was only evident in the sexual domain of the GSM group. Construct validity was established by comparing the EASQ-W with the MRS, yielding statistically significant correlations (0.33831-0.64580, p < 0.001). The test-retest reliability over a 4-week period was demonstrated to be satisfactory in both the GSM and control groups (ICC 0.787-0.977). Furthermore, the EASQ-W exhibited appropriate responsiveness to oral hormonal treatment (p < 0.001). Conclusion: This study successfully translated and validated the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese, with satisfactory internal consistency, test-retest reliability, and construct validity.

Evaluation of Sexual Function of Transgender Individuals.

PURPOSE: The current study sought to evaluate the sexual function of transgender men and women and to identify associated factors. METHODS: Trans individuals who were outpatients at our gender incongruence (GI) center for follow-up of gender-affirming hormone therapy with age ranging 27 to 50 years were invited to participate in this cross-sectional study. Clinical data were collected from the medical records. Two scales, the Female Sexual Function Index (FSFI) and the Male Sexual Function Index (MSFI), were administered to all females (n = 50) and all males (n = 58). Each participant also responded to a semi-structured questionnaire that assessed feelings regarding being transgender and satisfaction with sexual life. RESULTS: Relative to trans women, trans men had a higher total FSFI score, and higher scores in the FSFI domains of arousal, lubrication, orgasm, and satisfaction (all p < 0.01), and in the total MSFI score, and higher scores in the MFSI domains of arousal, erection, orgasm, and satisfaction (all p < 0.01). A separate semi-structured evaluation indicated that more than half of the trans men and almost half of the trans women were satisfied or very satisfied with their sexual life. CONCLUSIONS: The total scores from the FSFI and MSFI indicated a high risk of sexual dysfunction in trans men and especially, in trans women. However, the semi-structured evaluation showed that more than half of the trans men and almost half of the trans women were satisfied with their sexual life.

Effect of testosterone formulations on hematocrit in transgender individuals: A systematic review.

BACKGROUND: Approximately, 11% of trans men experience erythrocytosis diagnosis due to testosterone administration during the first year of the gender-affirming hormone treatment (GAHT). OBJECTIVES: To identify and compare the effect of different testosterone formulations on hematocrit (Hct) and diagnose erythrocytosis in trans men. MATERIALS AND METHODS: This systematic review was based on PRISMA guidelines. We performed an electronic search of PubMed, Embase, and Web of Science in January 2024. The Newcastle-Ottawa scale was used to evaluate the quality of evidence in the observational studies. RESULTS: Of the 152 records retrieved, 18 met the eligibility criteria. Studies observed an increase of up to 5% in Hct in trans men using injectable testosterone undecanoate (TU), and up to 6.9% in trans men using intermediate injectable testosterone esters (TE). Trans men using TE experience a larger increase in serum Hct levels compared to those receiving TU. Erythrocytosis prevalence varies according to the cutoff used (50%, 52%, and 54%). Erythrocytosis was also associated with tobacco use, age at initiation of hormone therapy, body mass index (BMI), and pulmonary conditions. Studies that evaluated the effect of testosterone formulation on erythrocytosis diagnosis present conflicting result. Trans men have a hazard ratio of 7.4 (95% CI: 4.1, 13.4) of developing erythrocytosis compared to cisgender men, using a 52% hematocrit cutoff. CONCLUSION: All testosterone formulations result in an increase in Hct, irrespective of dose, formulation, and administration method. Smoking, higher age at initiation of the testosterone therapy, higher BMI, and a predisposing medical history are associated with this increase in Hct. The difference in effect of TE and TU on Hct is conflicting, although it is important to point out that these data come from observational studies, retrospective, and with a small-sample size.

Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

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.

A Roadmap for Training in Urogynecology: IUGA International Initiative.

INTRODUCTION AND HYPOTHESIS: Training in urogynecology is an important mission of the International Urogynecological Association (IUGA). Promoting official training programs in countries around the world is an integral part of this mission. METHODS: The IUGA established the Fellowship Development Committee to develop a roadmap to assist countries to develop a professional training program in urogynecology. Two focus groups were created: the curricula topics focus group and the survey focus group. The curricula topics focus group is aimed at developing a list of subjects that can be the basis for a training syllabus. The survey focus group is aimed at understanding the main steps and the difficulties in establishing an official training program by interviewing representatives from both accredited and non-accredited countries and developing a roadmap for an official training program recognized by the local authorities. RESULTS: The fellowship development committee included 13 members. The curricula topics focus group developed a format for the description of each included topic. Each topic had to include a description of the required related skills and procedures. Two curricula topics lists were created: one for basic training and a second for advanced training. The survey focus group conducted two table discussions with representatives from countries with accredited training programs and countries without accredited training programs. The comments of these meetings were summarized in documents submitted to the IUGA board of directors. CONCLUSION: The fellowship development committee studied the main hurdles to developing an official training program in urogynecology. The roadmap document should form the basis of the IUGA international initiative to assist countries around the world to develop an official training program in urogynecology recognized by the local authority.

Assessment of sexual and body esteem in postpartum women with or without perineal laceration: a cross-sectional study with cultural translation and validation of the Vaginal Changes Sexual and Body Esteem Scale.

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.

Laser and Pelvic Floor Muscle Training for Urinary Incontinence: A Randomized Clinical Trial.

IMPORTANCE: Pelvic floor muscle training (PFMT) is considered the first option as a conservative treatment for female stress urinary incontinence (SUI). However, there is still debate whether energy-based devices are effective for treating SUI. OBJECTIVE: The objective of this study was to assess whether PFMT and fractional CO2 laser therapy may improve symptoms in women with SUI. STUDY DESIGN: A parallel, randomized, nonblinded, noninferiority trial included 94 of 144 women 18 years or older with SUI randomized into 2 groups. The CO2 laser group (n = 47) received 3 vaginal applications at monthly intervals. The PFMT group (n = 47) underwent 2 weekly sessions. Primary outcome was the mean difference of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI-SF) total scores between groups after 3 and 6 months. Main secondary outcomes were questionnaires for assessment of pelvic floor symptoms (Pelvic Floor Impact Questionnaire-Short Form 7 [PFIQ-7]), sexual function (Female Sexual Function Index [FSFI]), and improvement after treatment (Patient Global Impression of Improvement [PGI-I]). RESULTS: A reduction in the ICIQ-UI-SF total score, PFIQ total score, and the Urinary Impact Questionnaire score was perceived between baseline and 3-6 months in both groups. CO2 laser did not reach the noninferiority margin when compared with PFMT in both follow-up periods and analyses. Pelvic floor muscle training has improved the FSFI desire domain between baseline and 3-6 months, whereas CO2 laser improved the FSFI orgasm, pain, and total score after 3 months and FSFI orgasm and total score after 6 months. PGI-I assessment has shown an improvement in both groups. CONCLUSION: Fractional CO2 laser therapy was noninferior to PFMT after 3-6 months of treatment. Both groups presented a reduction in the ICIQ-UI-SF scores, and both methods could be considered for women with SUI.

Mobile app for pelvic floor muscle training for urinary incontinence during the coronavirus disease 2019 pandemic: clinical trial.

OBJECTIVE: The objective of this study was to evaluate the effects of home-based pelvic floor muscle training in women with urinary incontinence, addressing the difficulties arising from social isolation due to the coronavirus disease 2019 pandemic by utilizing a specialized mobile app. METHODS: This randomized, single-group clinical trial aimed to assess the efficacy of pelvic floor muscle training guided by a mobile app (Diario Saúde) in women with stress urinary incontinence. Participants were instructed via telephone to engage in pelvic floor muscle training exercises twice a day for 30 days. Pre- and post-treatment, participants completed validated questionnaires regarding urinary symptoms and quality of life through telephone interviews. Additionally, treatment adherence was evaluated. RESULTS: A total of 156 women were enrolled in the study, with a mean age of 49.3±14.2 years. Significant improvements in urinary incontinence symptoms and quality of life were observed following pelvic floor muscle training guided by the mobile app (p<0.001). Notably, 74.3% of the participants reported performing the exercises with appropriate frequency. Of the participants, 62% reported either complete or substantial improvement in urinary symptoms post-treatment. CONCLUSION: This study revealed notable enhancements in stress urinary incontinence, urinary storage, and overall quality of life subsequent to pelvic floor muscle training guided by a mobile app, particularly during the coronavirus disease 2019 pandemic. The mobile app demonstrated robust acceptance and adherence among women experiencing urinary incontinence.

Associated factors of vaginal laxity and female sexual function: a cross-sectional study.

BACKGROUND: Female sexual dysfunction (FSD), including vaginal laxity (VL), can lead to a decrease in quality of life and affect partner relationships. AIM: We aimed to investigate the associated factors of VL and FSD and their relationship with other pelvic floor disorders in a female population. METHODS: This cross-sectional study was conducted at Chelsea and Westminster Hospital from July to December 2022. All women referred to clinical care at the urogynecology clinic were included. Participants were assessed according to sociodemographic and clinical aspects, the Pelvic Organ Prolapse Quantification system, sexual function, VL, sexual attitudes, sexual distress, sexual quality of life, vaginal symptoms, and pelvic floor disorders. Unadjusted and adjusted associated factors of VL and FSD were analyzed. OUTCOMES: The primary outcome was the identification of the associated factors of VL and FSD in a female population, and secondary outcomes included the association between VL and pelvic organ prolapse (POP) with the questionnaire scores. RESULTS: Among participants (N = 300), vaginal delivery, multiparity, perineal laceration, menopause, and gel hormone were significantly more frequent in those reporting VL (all P < .05). When compared with nulliparity, primiparity and multiparity increased the odds of VL by approximately 4 and 12 times, respectively (unadjusted odds ratio [OR], 4.26 [95% CI, 2.05-8.85]; OR, 12.77 [95% CI, 6.53-24.96]). Menopause and perineal laceration increased the odds of VL by 4 and 6 times (unadjusted OR, 4.65 [95% CI, 2.73-7.93]; OR, 6.13 [95% CI, 3.58-10.49]). In multivariate analysis, menopause, primiparity, multiparity, and POP remained associated with VL. CLINICAL IMPLICATIONS: Parity, as an obstetric factor, and menopause and staging of POP, as clinical factors, were associated with VL. STRENGTHS AND LIMITATIONS: The investigation of associated factors for VL will contribute to the understanding of its pathophysiology. The study design makes it impossible to carry out causal inference. CONCLUSION: Menopause, primiparity, multiparity, and POP were highly associated with VL complaints in multivariate analysis.

Management of hypoactive sexual desire dysfunction at a specialized service in women's sexual health.

Hypoactive sexual desire dysfunction (HSDD) is prevalent among women. This retrospective cohort study aimed to verify the results of the strategies used by Gynecologists and Obstetricians (Ob-gyn) residents in the management of female HSDD. For this, we conducted a data collection of patient medical records of women with HSDD from the Human Sexuality Studies outpatient clinic of the Human Reproduction Center, Department of Gynecology and Obstetrics of FMRP-USP, from 2005 to 2019. Among the 437 women included, 361 (82.6%) answered the question concerning the effect of the protocol to which they were submitted, whereas 234 (64.8%) reported improvements in sexual desire. The univariate model showed that patients without chronic pelvic pain were 19.0% less likely to report improvements in HSDD than those with chronic pelvic pain (p = 0.03). Patients without depression and without orgasmic dysfunction were, respectively 32% and 23% more likely to show improvements in their HSDD than those who had depression or orgasmic dysfunction (respectively p = 0.001, p = 0.008). However, the multivariate model did not identify any associations. The assistance regarding HSDD by the Ob-gyn resident in training to deal with female sexual complaints may be effective in improving sexual complaints.

Treatment of women with vaginal laxity: systematic review with meta-analysis.

BACKGROUND: Despite several treatments that have been used for women reporting vaginal laxity (VL), to our knowledge no systematic review is available on the topic so far. AIM: In this study, we sought to summarize the best available evidence about the efficacy and safety of interventions for treating VL, whether conservative or surgical. METHODS: A comprehensive search strategy was performed in Medline, Embase, Scopus, Web of Science, and Cochrane Library for reports of clinical trials published from database inception to September 2022. Studies selected for inclusion were in the English language and were performed to investigate any type of treatment for VL, with or without a comparator, whether nonrandomized studies or randomized controlled trials (RCTs). Case reports and studies without a clear definition of VL were excluded. OUTCOMES: The outcomes were interventions (laser, radiofrequency, surgery, and topical treatment), adverse effects, sexual function, pelvic floor muscle (PFM) strength, and improvement of VL by the VL questionnaire (VLQ). RESULTS: From 816 records, 38 studies remained in the final analysis. Laser and radiofrequency (RF) were the energy-based treatment devices most frequently studied. Pooled data from eight observational studies have shown improved sexual function assessed by a Female Sexual Function Index score mean difference (MD) of 6.51 (95% CI, 5.61-7.42; i2 = 85%, P < .01) before and after intervention, whether by RF (MD, 6.00; 95% CI, 4.26-7.73; i2 = 80%; P < .001) or laser (MD, 6.83; 95% CI, 5.01-8.65; i2 = 92%; P < .01). However, this finding was not shown when only 3 RCTs were included, even when separated by type of intervention (RF or laser). When RF treatment was compared to sham controls, VLQ scores did not improve (MD, 1.01; 95% CI, -0.38 to 2.40; i2 = 94%; P < .001). Patient PFM strength improved after interventions were performed (MD, 4.22; 95% CI, 1.02-7.42; i2 = 77%; P < .001). The ROBINS-I (Risk Of Bias In Nonrandomized Studies of Interventions) tool classified all non-RCTs at serious risk of bias, except for 1 study, and the risk of bias-1 analysis found a low and unclear risk of bias for all RCTs. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) certainty of the evidence was moderate for sexual function and the VLQ questionnaire and low for PFM strength. CLINICAL IMPLICATIONS: Sexual function in women with VL who underwent RF and laser treatment improved in observational studies but not in RCTs. Improvement in PFM strength was observed in women with VL after the intervention. STRENGTHS AND LIMITATIONS: Crucial issues were raised for the understanding of VL, such as lack of standardization of the definition and for the development of future prospective studies. A limitation of the study was that the heterogeneity of the interventions and different follow-up periods did not make it possible to pool all available data. CONCLUSIONS: Vaginal tightening did not improve sensation in women with VL after intervention, whereas RF and laser improved sexual function in women with VL according to data from observational studies, but not from RCTs. PFM strength was improved after intervention in women with VL.

Pelvic floor muscle training as treatment for female sexual dysfunction: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to investigate the efficacy of pelvic floor muscle training in treating female sexual dysfunction. DATA SOURCES: A systematic review of databases, including PubMed, Ovid Medline, CINAHL, Embase, BVSalud, Scopus, and Cochrane Library, was performed in July 2021 and updated in May 2023. STUDY ELIGIBILITY CRITERIA: Full-text articles of randomized controlled trials comparing pelvic floor muscle training with no intervention or another conservative treatment were included. At least 1 arm of these trials aimed to improve women's sexual function or treat sexual dysfunction. METHODS: The data for this review were extracted and analyzed by 2 independent reviewers. Data on the characteristics of each intervention were extracted using the Consensus on Exercise Reporting Template. The risk of bias and certainty of evidence were assessed using the Physiotherapy Evidence Database (PEDro) scale and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria, respectively. A meta-analysis was conducted considering the posttreatment mean score difference in the Female Sexual Function Index between the control and treatment groups. RESULTS: A total of 21 randomized controlled trials were included in this review. The Consensus on Exercise Reporting Template revealed varying quality of the pelvic floor muscle training protocols. Four studies were included in the meta-analysis showing that pelvic floor muscle training improved arousal (1.49; 95% confidence interval, 0.13-2.85), orgasm (1.55; 95% confidence interval, 0.13-2.96), satisfaction (1.46; 95% confidence interval, 0.14-2.77), pain (0.74; 95% confidence interval, 0.11-1.37), and the Female Sexual Function Index overall score (7.67; 95% confidence interval, 0.77-14.57). Very low certainty of evidence due to the data's high clinical and statistical heterogeneity was found according to the GRADE criteria. No side effects of the interventions were reported. CONCLUSION: This systematic review and meta-analysis showed that pelvic floor muscle training improved female Female Sexual Function Index total score and several subscales; however, the certainty of the evidence is low.

Transobturator Versus Minisling for Urinary Incontinence: A Randomized Controlled Trial.

IMPORTANCE: The comparison between single-incision slings (SISs) and midurethral slings has been documented in the literature, but results vary according to the SIS device. OBJECTIVES: The purpose of this study is to assess whether SIS (Solyx) is noninferior to transobturator (TOT) (Obtryx) sling for treating women with confirmed stress-predominant urinary incontinence. STUDY DESIGN: A prospective, parallel, nonblinded, multicenter, noninferiority, randomized controlled study with 114 patients were randomized and followed 6 and 12 months after surgery. Interventions were midurethral TOT sling (Obtryx-halo; n = 58) or SIS (Solyx; n = 56). The primary outcome was improvement in the Patient Global Impression of Improvement (PGI-I). Secondary outcomes were the Kings Health Questionnaire (KHQ) instruments after treatment, subjective improvement, and surgical outcomes. RESULTS: Both groups were homogeneous ( P = NS) regarding sociodemographic and clinical variables. There was improvement in the PGI-I after 6 ( P = 0.001) and 12 months ( P = 0.001) of treatment for women who underwent TOT sling. After 6 months, KHQ scores improved in the TOT group for the following domains: role limitations ( P = 0.026) and physical limitations ( P = 0.006). After 12 months, the TOT group presented better KHQ scores that were statistically significant from the SIS group in incontinence impact ( P = 0.012), physical limitations ( P = 0.001), and severity measures ( P = 0.017). Moreover, the TOT group presented higher subjective improvement after 6 months ( P = 0.006) than the SIS group. Mesh erosion was higher in the SIS group ( P = 0.006). Reoperations were not statistically different between groups. CONCLUSION: There were higher scores in the PGI-I score and higher subjective improvement for the TOT sling after 6 and 12 months of treatment when compared with the SIS group.

Pilot study of treatment of patients with deep infiltrative endometriosis with methotrexate carried in lipid nanoparticles.

OBJECTIVE: Previously, lipid nanoparticles (LDE) injected in women with endometriosis were shown to concentrate in the lesions. Here, the safety and feasibility of LDE carrying methotrexate (MTX) to treat deep infiltrating endometriosis was tested. DESIGN: Prospective pilot study. SETTING: Perola Byington Hospital Reference for Women's Health. SUBJECTS: Eleven volunteers (aged 30-47 years, BMI 26.15 ± 6.50 kg/m2) with endometriosis with visual analog scale pelvic pain scores (VAS) > 7 and rectosigmoid lesions were enrolled in the study. INTERVENTION: Three patients were treated with LDE-MTX at single intravenous 25 mg/m2 dose of MTX and eight patients with two 25 mg/m2 doses with 1-week interval. MAIN OUTCOME MEASURES: Clinical complaints, blood count, and biochemistry were analyzed before treatment and on days 90, 120, and 180 after LDE-MTX administration. Endometriotic lesions were evaluated by pelvic and transvaginal ultrasound (TVUS) before treatment and on days 30 and 180 after LDE-MTX administration. RESULTS: No clinical complaints related with LDE-MTX treatment were reported by the patients, and no hematologic, renal, or hepatic toxicities were observed in the laboratorial exams. FSH, LH, TSH, free T4, anti-Müllerian hormone, and prolactin levels were also within normal ranges during the observation period. Scores for deep dyspareunia (p < 0.001), chronic pelvic pain (p = 0.008), and dyschezia (p = 0.025) were improved over the 180-day observation period. There was a non-significant trend for reduction of VAS scores for dysmenorrhea. Bowel lesions by TVUS were unchanged. No clear differences between the two dose levels in therapeutic responses were observed. CONCLUSION: Results support the safety and feasibility of using LDE-MTX in women with deep infiltrating endometriosis as a novel and promising therapy for the disease. More prolonged treatment schemes should be tested in future placebo-controlled studies aiming to establish the usefulness of this novel nanomedicine approach.

Assessing a cut-off point for the diagnosis of abnormal uterine bleeding using the Menstrual Bleeding Questionnaire (MBQ): a validation and cultural translation study with Brazilian women

ABSTRACT BACKGROUND: Abnormal uterine bleeding (AUB) is a common condition, and the Menstrual Bleeding Questionnaire (MBQ) is used for its assessment. OBJECTIVES: To translate, assess the cut-off point for diagnosis, and explore psychometric properties of the MBQ for use in Brazilian Portuguese. DESIGN AND SETTING: Prospective cohort study including 200 women (100 with and 100 without AUB) at a tertiary referral center. METHODS: MBQ translation involved a pilot-testing phase, instrument adjustment, data collection, and back-translation. Cut-off point was obtained using receiver operating curve analysis. Menstrual patterns, impact on quality of life due to AUB, internal consistency, test-retest, responsiveness, and discriminant validity were assessed. For construct validity, the Pictorial Blood Assessment Chart (PBAC) and World Health Organization Quality of Life - abbreviated version (WHOQOL-BREF) were applied. RESULTS: Women with AUB were older, had higher body mass indices, and had a worse quality of life during menstruation. Regarding the MBQ's psychometric variables, Cronbach's alpha coefficient was > 0.70 in all analyses, high intraclass correlation coefficient was found in both groups; no ceiling and floor effects were observed, and construct validity was demonstrated (correlation between MBQ score, PBAC score, and clinical menstrual cycle data). No difference between MBQ and PBAC scores were perceived after the test-retest. Significant differences were found between MBQ and PBAC scores before and after treatment. An MBQ score ≥ 24 was associated with a high probability of AUB; accuracy of 98%. CONCLUSION: The MBQ is a reliable questionnaire for Brazilian women. The cut-off ≥ 24 shows high accuracy to discriminate AUB.

Assessment of sexual and body esteem in postpartum women with or without perineal laceration: a cross-sectional study with cultural translation and validation of the Vaginal Changes Sexual and Body Esteem Scale

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.

Validation and cultural translation for the Brazilian Portuguese version of the Estro-Androgenic- Symptom Questionnaire in Women

Abstract Objective This study aimed to translate and validate the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese language, as we hypothesized that this tool would be consistent for addressing the specific context of hormonal symptoms in menopause. Methods In a cross-sectional study, a total of 119 women with Genitourinary Syndrome of Menopause (GSM) and 119 climacteric women without GSM were included. The EASQ-W was translated, and its psychometric properties were rigorously examined. Participants completed questionnaires covering sociodemographic details, the EASQ-W, and the Menopause Rating Scale (MRS). A subgroup of 173 women was re-invited after 4 weeks for test-retest analysis of the EASQ-W. Additionally, the responsiveness of the questionnaire was evaluated in 30 women who underwent oral hormonal treatment. Results The internal consistency of the EASQ-W was found to be satisfactory in both GSM and control groups (Cronbach's alpha ≥ 0.70). Notably, a floor effect was observed in both groups; however, a ceiling effect was only evident in the sexual domain of the GSM group. Construct validity was established by comparing the EASQ-W with the MRS, yielding statistically significant correlations (0.33831-0.64580, p < 0.001). The test-retest reliability over a 4-week period was demonstrated to be satisfactory in both the GSM and control groups (ICC 0.787-0.977). Furthermore, the EASQ-W exhibited appropriate responsiveness to oral hormonal treatment (p < 0.001). Conclusion This study successfully translated and validated the Estro-Androgenic-Symptom Questionnaire in Women (EASQ-W) into Brazilian Portuguese, with satisfactory internal consistency, test-retest reliability, and construct validity.

Mobile app for pelvic floor muscle training for urinary incontinence during the coronavirus disease 2019 pandemic: clinical trial

SUMMARY OBJECTIVE: The objective of this study was to evaluate the effects of home-based pelvic floor muscle training in women with urinary incontinence, addressing the difficulties arising from social isolation due to the coronavirus disease 2019 pandemic by utilizing a specialized mobile app. METHODS: This randomized, single-group clinical trial aimed to assess the efficacy of pelvic floor muscle training guided by a mobile app (Diario Saúde) in women with stress urinary incontinence. Participants were instructed via telephone to engage in pelvic floor muscle training exercises twice a day for 30 days. Pre- and post-treatment, participants completed validated questionnaires regarding urinary symptoms and quality of life through telephone interviews. Additionally, treatment adherence was evaluated. RESULTS: A total of 156 women were enrolled in the study, with a mean age of 49.3±14.2 years. Significant improvements in urinary incontinence symptoms and quality of life were observed following pelvic floor muscle training guided by the mobile app (p<0.001). Notably, 74.3% of the participants reported performing the exercises with appropriate frequency. Of the participants, 62% reported either complete or substantial improvement in urinary symptoms post-treatment. CONCLUSION: This study revealed notable enhancements in stress urinary incontinence, urinary storage, and overall quality of life subsequent to pelvic floor muscle training guided by a mobile app, particularly during the coronavirus disease 2019 pandemic. The mobile app demonstrated robust acceptance and adherence among women experiencing urinary incontinence.

Adaptation and Validation of the International Pelvic Pain Society's Quality of Life Questionnaire in Portuguese.

OBJECTIVE: In the present study, our aim was to translate, adapt, and validate the Pelvic Health History Form (a quality of life [QoL] questionnaire) of the International Pelvic Pain Society (IPPS) from English to Portuguese. METHODS: The study was approved by the Ethics and Research Committee (CEP, in the Portuguese acronym) and the IPPS. The "Transcultural Adaptation" method comprised 5 stages: translation, synthesis, backtranslation, expert review, and pretest. Cultural adaptation and validation included cognitive interviews and statistical analysis of unanswered items (> 15%) in 14 clinic patients from CPP and endometriosis clinic at Santa Casa de São Paulo. RESULTS: Strong equivalences were established between the USA and Brazil questionnaires in terms of semantics, idioms, experiences, and concepts. Eighteen culturally inappropriate items were identified and adjusted using the revised response rate index. The subjective form underwent rigorous assessments, confirming its accurate measurement of intended targets. CONCLUSION: The methodology showed efficiency and equivalence, confirming its validity. The user-friendly format and inclusion of translated, adapted, and validated instruments in Portuguese make the form valuable for evaluating pelvic health, with potential for future research.

OBJETIVO: Realizar a tradução, adaptação e validação do questionário de qualidade de vida Pelvic Health History Form da International Pelvic Pain Society (IPPS, na sigla em inglês) para a língua portuguesa. MéTODOS: Aprovação do Comitê de Ética e Pesquisa (CEP) e consentimento do IPPS. A metodologia "Adaptação Transcultural" foi utilizada em cinco etapas: (I) tradução; (II) síntese; (III) retradução; (IV) revisão pelo comitê de especialistas; (V) pré-teste, seguido de adaptação cultural e validação por meio de entrevista cognitiva e análise estatística da taxa de ausência de respostas > 15% após aplicação do instrumento em 14 pacientes do ambulatório de DPC e endometriose da Santa Casa de São Paulo. RESULTADOS: Equivalências semântica, idiomática, experiencial e conceitual entre o questionário de país fonte (EUA) e alvo (Brasil) foram bem estabelecidas. Dezoito itens culturalmente impróprios, de acordo com o índice de ausência de respostas revisados, adaptados e realizada validade de face e de constructo, avaliando forma subjetiva, confiável que o instrumento mede o que pretende medir. CONCLUSãO: A metodologia utilizada foi eficiente, com boa equivalência com o material de origem concluindo a sua validade. Formulário de formato simples, fácil aplicação e compreensão, composto por diversos instrumentos já traduzidos, adaptados e validados em nossa língua. O formulário auxilia avaliação multidimensional da saúde pélvica destas pacientes e poderá ser utilizado em estudos futuros.