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.

The personal experience of female obstetricians and gynaecologists with contraceptive use influences the guidance and prescription of contraceptive methods: a web-survey.

OBJECTIVE: To evaluate the influence of the personal experience of female obstetricians and gynaecologists (Obst/Gyns) who utilise contraceptive methods on the provision of these methods. METHODS: An anonymous online web-based survey was carried out with female Obst/Gyns. The instrument contained questions about their current and previous contraceptive methods use, factors that influenced the choice and satisfaction with the ongoing method, as well as the occurrence of adverse events. They were also asked whether the experience of any adverse events influenced their decision in prescribing any particular contraceptive method. RESULTS: 476/9000 (5.3%) female Obst/Gyns answered the survey. The most common contraceptive in use was the 52-mg levonorgestrel-intrauterine device (52-mg LNG-IUD) (34%), followed by non-Long-Acting Reversible Contraception hormonal methods (21.2%). More than half of the respondents (57.6%) reported having some adverse effects and 18.7% reported that the personal experience of an adverse effect with the use of a contraceptive method influenced the prescription of that method. CONCLUSION: Half of female Obst/Gyns encountered adverse events linked to contraceptive usage. Additionally, almost one-fifth believe that their own encounter with adverse effects from a contraceptive method impacts their decision to prescribe the same method.

Almost one-fifth of the female obstetrics and gynaecologists that answered the online survey reported that the personal experience of an adverse effect with the use of a contraceptive method influenced the prescription of that method.

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.

Gene expression associated with unfavorable vaginal bleeding in women using the etonogestrel subdermal contraceptive implant: a prospective study.

To evaluate gene expression associated with unfavorable vaginal bleeding in users of the Etonogestrel (ENG) contraceptive implant. Prospective study involving 100 women who intended to use the ENG implant. Exclusion criteria included abnormal uterine bleeding, inability to attend a 1-year follow-up, and implant removal for reasons unrelated to vaginal bleeding or loss of follow-up. We obtained endometrial biopsies before implant placement and assessed the expression of 20 selected genes. Users maintained a uterine bleeding diary for 12 months post-implant placement. For statistical analysis, we categorized women into those with or without favorable vaginal bleeding at 3 and 12 months. Women with lower CXCL1 expression had a 6.8-fold increased risk of unfavorable vaginal bleeding at 3 months (OR 6.8, 95% CI 2.21-20.79, p < 0.001), while those with higher BCL6 and BMP6 expression had 6- and 5.1-fold increased risks, respectively. By the 12-month follow-up, women with lower CXCL1 expression had a 5.37-fold increased risk of unfavorable vaginal bleeding (OR 5.37, 95% CI 1.63-17.73, p = 0.006). Women with CXCL1 expression < 0.0675, BCL6 > 0.65, and BMP6 > 3.4 had a higher likelihood of experiencing unfavorable vaginal bleeding at 3 months, and CXCL1 < 0.158 at 12 months. Users of ENG contraceptive implants with elevated BCL6 and BMP6 expression exhibited a higher risk of breakthrough bleeding at the 3-month follow-up. Conversely, reduced CXCL1 expression was associated with an elevated risk of bleeding at both the 3 and 12-month follow-ups.

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.

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.

Barriers to accessing post-pregnancy contraception in Brazil: The impact of COVID-19.

The aim of our article is to discuss barriers associated with post-pregnancy contraception in Brazil during the SARS-CoV-2 (COVID-19) pandemic. Socioeconomic differences in gaining access to long-acting reversible contraceptive (LARC) methods became greater during the COVID-19 pandemic. The inadequate distribution of existing resources and the reduced capacity for elective care meant that healthcare providers in family planning had to be reallocated to respond to COVID-19 emergencies. In Brazil, 74% of the population depends on the national health service (Sistema Unico de Saúde) including for the provision of free contraception. However, the only LARC method available at the public service is the copper-intrauterine device (IUD); implants and hormonal-IUDs are not available, except at some teaching hospitals. Contraceptive sales remained unmodified during the pandemic, which shows that the majority of the population used less effective or no contraceptive methods during this time. However, sales of implants and the hormonal-IUD increased significantly, indicating the inequity of the low-income portion of the society as only the wealthy can afford these. On the other hand, there was an increase in sales of emergency contraception. The uptake of postpartum IUDs and contraceptive implants at the selected teaching hospitals in which they were available was high during the COVID-19 pandemic as they were the only methods immediately available. In conclusion, the COVID-19 pandemic increased both inequality and social differences in gaining access to contraceptives. Postpartum and immediate post abortion methods were also good strategies during the pandemic and were well accepted by the population. However, they were not offered by most services.

Gene expression associated with vaginal bleeding in women using the 52-mg levonorgestrel hormonal intrauterine device: A prospective study.

OBJECTIVE: To evaluate gene expression associated with vaginal bleeding in the 52-mg hormonal intrauterine device (IUD) users. MATERIALS AND METHODS: We conducted a prospective study involving 100 women seeking to use the 52-mg hormonal IUD for contraception. We excluded women with a history or current condition of abnormal uterine bleeding and who were unable to attend a 1-year follow up. Women who expelled the device, removed it for reasons unrelated to vaginal bleeding, or were lost to follow up were discontinued. We collected endometrial biopsies immediately before IUD placement and assessed 20 selected genes using reverse transcription quantitative polymerase chain reaction. Users maintained a uterine bleeding diary for 12 months following IUD insertion. For statistical analysis, participants were categorized into groups with or without vaginal bleeding at 3 and 12 months. RESULTS: Women with elevated CXCL9 expression had an 8.15-fold higher likelihood of experiencing vaginal bleeding at 3 months (odds ratio [OR] 8.15, 95% confidence interval [CI] 2.24-29.61, P = 0.001). At 12 months of follow up, women with increased TIMP1 expression had a 2.74-fold higher chance of experiencing vaginal bleeding (OR 2.74, 95% CI 1.08-6.95, P = 0.033). CXCL9 ≥ 1.5 and IL17A ≥ 0.68 were associated with a higher probability of vaginal bleeding at 3 months, while TIMP1 levels ≥0.943 were linked to an increased risk of bleeding at 12 months. CONCLUSION: Users of the 52-mg hormonal IUD with elevated relative CXCL9 expression face an increased risk of vaginal bleeding at 3-month follow up, whereas those with heightened TIMP1 expression are more likely to experience vaginal bleeding at 12 months.

Effectiveness and continuation rates of the etonogestrel-subdermal contraceptive implant versus short-acting contraceptive methods offered at no cost in Campinas, Brazil.

OBJECTIVES: To compare the efficacy, reasons for discontinuation and continuation rates of the etonogestrel (ENG)-subdermal contraceptive implant when offered at no cost, and the basis of free choice versus short-acting reversible contraceptive (SARC) methods including combined oral contraceptives (COCs), once-a-month injectables, vaginal ring, and patch. METHODS: We conducted a prospective study at the University of Campinas, Brazil, involving women aged 18 to 40 years. They were counseled on various contraceptive methods before entering the study and followed up every 3 months for up to 24 months. Satisfaction was assessed using a Likert scale. Survival rates were estimated using the Kaplan-Meier test, and curve comparisons were performed using the log-rank test. RESULTS: We enrolled 609 women including 358/609 women (58.8%) who chose the ENG-implant and 251/609 (41.2%) who chose SARC methods. Contraceptive failure and all other reasons for discontinuation were significantly higher in SARC users compared to the ENG-implant users (P < 0.001 and P = 0.002, respectively). The continuation rate was higher among ENG-implant users (89.9% and 75.4%) compared to SARC methods users (27.2% and 15.9%) up to 1 and 2 years after study initiation, respectively. Satisfaction was high in both groups (>82%). CONCLUSIONS: The ENG-implant showed higher contraceptive effectiveness and higher continuation rates than SARC methods up to 2 years after study initiation. Furthermore, users from both groups were highly satisfied with their contraceptive. The main reason for discontinuing use of the ENG-implant was bothersome uterine bleeding, while for SARC methods it was for personal reasons.

Use of a Mobile Application for Pelvic Floor Muscle Training in Women With Urinary Incontinence: a Randomized Control Trial.

INTRODUCTION AND HYPOTHESIS: This study was aimed at evaluating the impact of a mobile app-guided pelvic floor muscle training (PFMT) program on urinary symptoms and quality of life in women suffering from urinary incontinence. METHODS: The study included women with stress urinary incontinence (SUI), who underwent a structured interview and completed validated questionnaires, including the Questionnaire for Urinary Incontinence Diagnosis (QUID), the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and the Incontinence Quality of Life Questionnaire (I-QOL). These women were randomly assigned to one of two groups: the app group, which received a visual depiction on the expected contraction pattern through a mobile app to support their PFMT exercises, and the control (paper) group. Both groups were instructed to perform PFMT exercises twice daily for 30 days. Data were collected at baseline and at 30, 60, 90, and 120 days after completing the exercises. RESULTS: A total of 154 women participated, with 76 in the app group and 78 in the paper group. The mean ages were 61 (± 6.1) and 60.6 (± 6.8) in the app and paper groups respectively (p = 0.644). Both groups showed significant improvements in QUID SUI scores (p < 0.001), overactive bladder (OAB; p < 0.001), ICIQ-SF scores (p < 0.001), and quality-of-life scores (p < 0.001). When comparing the two groups, the app group exhibited a more substantial reduction in OAB (p = 0.017) as assessed by QUID and total (p = 0.042), psychosocial (p = 0.032) and social embarrassment (p = 0.006) I-QOL scores. CONCLUSIONS: The study findings suggest that PFMT guided by a mobile app with visual guidance leads to greater improvements in storage symptoms and quality of life than the home-based PFMT guidance.

Uptake, discontinuation, and continuation rate of long-acting contraceptive methods when offered at no cost in Campinas, Brazil.

OBJECTIVES: This study aimed to compare the uptake, reasons for discontinuation, continuation, and satisfaction of long-acting contraceptive methods (LARC) when offered at no cost in Campinas, Brazil. STUDY DESIGN: This was a prospective cohort study conducted at University of Campinas, Campinas, São Paulo, Brazil, including women aged 18 to 48 years, who adopted one of three methods. Participants underwent telephone follow-up every 3 months for up to 24 months after insertion. Satisfaction was assessed at the end of 2 years of use through the Likert scale. RESULTS: We invited 1222 women, and among the 971 women who volunteered to participate in follow-up, 414 (42.6%) chose the levonorgestrel 52-mg intrauterine device (IUD), 358 (36.9%) chose the etonogestrel (ENG) implant, and 199 (20.5%) chose the TCu380A IUD. Discontinuation due to bothersome bleeding was higher among users of the ENG implant (10/358; 2.4%) and the TCu380A IUD (32/199; 8.9%), and expulsion was higher for the TCu380A IUD (30/199; 15.1%). Women continued at 24 months were 340/414 (82.1%), 270/358 (75.4%), and 119/199 (59.8%) among users of the levonorgestrel 52-mg IUD, ENG implant, and TCu380A IUD, respectively. The users of the levonorgestrel 52-mg IUD (301/339, 88.8%), the ENG-implant (222/270, 82.2%), and the TCu380A IUD (105/119, 88.2%) were satisfied or very satisfied by 24 months of follow-up. CONCLUSIONS: The three LARC methods had great uptake, high continuation, and discontinuation due to bothersome bleeding was higher among users of the ENG implant and the TCu380A IUD, and expulsion was higher for the TCu380A IUD compared to the 52-mg levonorgestrel IUD. Most of the participants reported being very satisfied. IMPLICATIONS: When the LARC methods were offered at no cost in a Brazilian public clinic the uptake, satisfaction and continuation were high by 24 months after device placement, and high level of satisfaction was reported by most of the participants.

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.

Clinical Assessment of 3 Intrauterine Devices in Adolescent Girls: A Randomized Clinical Trial.

STUDY OBJECTIVE: To assess clinical performance, bleeding pattern, dysmenorrhea, and satisfaction up to 1 year after placement of 3 types of intrauterine devices (IUDs) (TCu380A, levonorgestrel 52 mg, and levonorgestrel 19.5 mg) in adolescents METHODS: The study was a randomized trial with 318 adolescents allocated to the 3 IUDs. We assessed reasons for removal, continuation, menstrual patterns, dysmenorrhea, and satisfaction. RESULTS: Participants aged (mean ± SD) 17.9 ± 1.4 years, with 80.8% being nulligravidae. After 1 year, 265 (83.3%) continued using the IUD; however, the continuation rate of TCu380A (75.4 ± 4.2) was lower than that of both the levonorgestrel 52-mg (88.6 ± 3.1) and 19.5-mg IUDs (86.8 ± 3.3), and bleeding/pain and expulsion were the main reasons for removal of the TCu380A IUD. The duration of menstruation was longer among the TCu380A IUD users (6.0 ± 2.0 days) than those using the levonorgestrel 52 mg (2.5 ± 3.9) and 19.5 mg (3.2 ± 3.2) devices, P < .001. Amenorrhea was reported by 49.5% and 37.8% users of the levonorgestrel 52-mg and 19.5-mg devices, respectively, P < .001. Dysmenorrhea was reported in 68.5% of all participants at the baseline; this was 67.9% of the TCu380A group and 33.3% and 36.0% of the levonorgestrel 52-mg and 19.5-mg IUD groups, respectively, P < .001. Satisfaction ranged from 80.7% in the TCu380A group to 97.8% in the levonorgestrel 52-mg group (P = .03). CONCLUSION: The 3 IUDs are suitable for adolescents, with high contraceptive efficacies and rates of continuation within 1 year of use and high degrees of satisfaction. Users of the hormonal IUDs reported lower expulsion rates, more favorable menstrual patterns, and less dysmenorrhea compared with the TCu380A IUD.

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.

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.

Provision of contraceptives by Brazilian general gynaecologists: a nationwide online survey.

OBJECTIVE: To assess the provision of contraceptives by Brazilian obstetricians and gynaecologists (Obst/Gyns) during medical consultation and associated factors. METHODS: An anonymous online survey was conducted with Obst/Gyns regarding age, gender, training, method counselling about and provision of long-acting reversible contraception (LARC). RESULTS: Of 16,000 Obst/Gyns, 610 (3.8%) answered the survey. After multiple regression analysis, female Obst/Gyns (reference) (OR male was 0.53 [95%CI 0.28-0.98], p = 0.044) and Obst/Gyns aged between 20 and 39 were more likely to provide an IUD. For hormonal-IUDs, Obst/Gyns who had had theoretical training in hormonal-IUD insertion (reference no training) (OR = 2.13 [95%CI 1.14-3.99], p = 0.018), those who work in a private facility or public hospital, and those that allowed more time during consultations (reference) (OR short time = 0.33 [95%CI 0.17-0.63], p < 0.001) were more likely to provide them. Obst/Gyns who were hands-on trained were more likely to provide subdermal implant (OR = 2.04 [95%CI 1.45-2.87], p < 0.001). CONCLUSIONS: There is a gap between theoretical and practical training received by this cohort of Obst/Gyns regarding LARCs, mainly contraceptive implants and hormonal-IUDs. The identification of barriers to offering contraceptives is essential to providing client-centred contraceptive care.

There is a gap between the theoretical and practical training received by Brazil-based Obst/Gyns regarding LARC methods, mainly subdermal implants and hormonal-IUDs. The identification of barriers is essential to providing client-centred contraceptive care.

Expulsion and continuation rates of the 52 mg levonorgestrel intrauterine system in adolescents and adult women.

OBJECTIVE: To compare the continuation rates, expulsion, and other reasons for discontinuation of the hormonal intrauterine device with 52 mg of levonorgestrel (52 mg LNG-IUD) in adolescents and adult women. METHODS: We conducted a retrospective cohort study that included 393 women in whom we placed a 52 mg LNG-IUD and followed up to 5 years. We created two retrospective cohorts, one with 131 adolescents (aged between 12 and 19 years) and the other with 262 women aged ≥20 years. Each adolescent was paired with two adult women who had the same parity and who had a 52 mg LNG-IUD inserted on the same day. We used the Mann-Whitney test to compare numerical variables in both groups, the Kaplan-Meier method, and the log-rank test to compare the continuation, expulsion and other reasons for IUD discontinuation of the two groups. RESULTS: Age of the adolescents and adult women were mean ± SD 18.1 (±1.1) and 31 (±6.8) years, respectively (p = 0.015). Continuation rates by the fifth year of use were 55.6/100 women-years (W-Y) and 70.3/100 W-Y among adolescents and adult women (p = 0.106); and expulsion rates were 8.4/100 and 6.0/100 W-Y, respectively (p = 0.463). Adolescents had a lower continuation rate during 3 to 5 years of follow-up (p = 0.011) and a high rate of removals due to bleeding/pain (18.5 ± 5.7/100 W-Y vs 6.4/100 ± 2.1 W-Y, p = 0.039). CONCLUSION: Adolescents who used the 52 mg LNG-IUD showed a lower continuation rate 3-5 years after device placement than adult women. The expulsion rates were similar in both groups.

Adolescents who used the 52 mg LNG-IUD showed expulsion rates similar than adult women. Despite the good continuation rate, adolescents had a lower continuation rate within 3­5 years of follow-up and high rate of removals due to bleeding/pain than adult users.

Women's perspectives on impact on the post menopause of use of the 52 mg levonorgestrel intrauterine device during the menopausal transition.

OBJECTIVES: To assess perimenopausal users of 52 mg levonorgestrel intrauterine devices (LNG-IUD) regarding the IUD impact after menopause. MATERIAL AND METHODS: a cross-sectional study with users aged 40 and 49 years old, without cognitive impairment that answered a questionnaire regarding worries and benefits after the menopause due to LNG-IUD use. RESULTS: Almost half of 221 users (52.9%) have concerns that LNG-IUD use could influence aspects after menopause, 111 (50.3%) that the post-menopause symptoms get worse and 92 (41.6%) that interfere with recognition of menopausal symptoms. CONCLUSION: Half of perimenopausal LNG-IUD users expressed concerns about how device use could affect post-menopause symptoms.

The 52 mg hormonal-IUD who were at menopausal transition reported worries that the use of the IUD can affect menopausal symptoms. It is important that health professionals can routinely guide these women.