Unilateral and Bilateral Transcutaneous Tibial Nerve Stimulation in Women With Overactive Bladder Syndrome: A Randomized Controlled Study (UBTTNS-OAB Study).

INTRODUCTION: The efficacy of unilateral versus bilateral Transcutaneous Tibial Nerve Stimulation (TTNS) for women with Overactive Bladder Syndrome (OAB) remains uncertain. OBJECTIVE: To compare the efficacy of unilateral and bilateral TTNS in the tibial region in women with OAB. METHODS: This randomized, controlled, triple-blind clinical trial included women with OAB or urgency-predominant urinary incontinence (UUI). Participants were randomized (1:1) into the Unilateral Tibial Group or Bilateral Tibial Group. Before treatment, they underwent a pre-assessment including peripheral sensitivity examination and completion of sociodemographic data and seven validated questionnaires on urinary symptoms, quality of life, sleep, and psycho-emotional aspects. TTNS interventions were administered twice weekly (12 sessions, 30 min each). Posttreatment, participants underwent another physical examination and completed the same questionnaires, with a 30-day follow-up. Categorical variables were analyzed using Chi-square or Fisher's Exact Test, while numerical variables were assessed with the Mann-Whitney test. Group comparisons over time utilized intention-to-treat ANOVA (p < 0.05). RESULTS: Thirty-five women participated: 17 in the unilateral group and 18 in the bilateral group. Mean ages were 55.1 (±14.7) years and 52.7 (±12.6) years, respectively (p = 0.680). Initial OAB severity (ICIQ-OAB) did not differ significantly between groups (p = 0.561). Both groups showed significant improvement in ICIQ-OAB scores: unilateral group from 10.1 (±3.4) to 5.8 (±3.4) (p < 0.001), bilateral group from 9.3 (±3.3) to 5.1 (±4) (p < 0.001), with no intergroup difference (p = 0.395). Improvement in UUI symptoms was observed: unilateral group from 2.2 (±1.4) to 0.7 (±1.5), bilateral group from 1.5 (±1.9) to 0.2 (±0.5), without significant intergroup difference (p = 0.645). Quality of life scores improved similarly between groups (p = 0.055). CONCLUSION: TTNS appears to be effective in improving bladder storage and UUI symptoms in women with OAB, with no difference between unilateral and bilateral applications. CLINICAL TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (REBEC) (RBR: 96f2fgkn).

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.

Prospective Evaluation of Ease and Difficulties of 869 Cases of Intrauterine Devices Removals.

OBJECTIVES: The objective was to describe the ease and difficulty of removing intrauterine devices (IUDs). METHODS: We conducted a prospective study at the University of Campinas (UNICAMP), Faculty of Medical Sciences, UNICAMP. We included women who requested IUD removal. We excluded women with partial IUD expulsion in which the IUD was protruded at the external os. We identified difficult IUD removal when the removal was challenging, including the inability to visualize IUD strings extending from the cervical os. RESULTS: A total of 869 women participated. Women were aged 29.4 ± 8.0 years (mean ± SD; range 14-51) and the duration of IUD use at the time of removal was 4.3 ± 4.2 years. We found that 702 (80.8%) women had visible strings at the external os and the removals were performed at the first attempt without difficulty in 692 (79.6%) participants. The pain was more intense (>4) in cases of difficult removals. After multivariate logistic analysis, difficult removals were associated with users of IUD ≥3 years (3 times higher risk); for each previous cesarean delivery, the risk increased by 1.5 times. CONCLUSIONS: Our study showed that IUD removal is an easy and safe procedure, with only a small proportion of women reporting significant pain with IUD removal.

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.

Sexual function after energy-based treatments of women with urinary incontinence. A systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) affects approximately 50% of adult women worldwide and is associated with declining sexual function (SF). Energy-based devices emerged as a minimally invasive alternative treatment. Nevertheless, their effect on sexuality is uncertain. We hypothesize that the UI energy treatment can lead to sexual function improvement. METHODS: A search was performed in PubMed, Cochrane Library, Web of Science, Embase, and Scopus for randomized clinical trials (RCTs) and nonrandomized studies of intervention, which treated incontinent women using energy, with UI and sexual function (SF) as outcomes. Severe comorbidities, pelvic organ prolapse (POP)> grade 2, and use of medication to treat UI or that affects SF were excluded. Quality assessment and meta-analysis were performed. RESULTS: From 322 articles, 11 RCTs were included for qualitative analysis. UI symptoms improved in all studies. Regarding SF, RCT with premenopausal women showed improvement in SF in the Er:Yag group (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 and Female Sexual Function Index). A prospective study showed improvement in SF independent of the grade of SUI. RF showed benefits for SF but was not superior to pelvic floor muscle training. One nonrandomized study of intervention with a High-Intensity Focused Electromagnetic Field showed significant improvement of SF in the Golombok Rust Inventory of Sexual Satisfaction total score, a decline in pain and dissatisfaction domains. Meta-analysis with 4 RCTs and 2 nonrandomized studies found no difference between groups (0.26 (95% CI -0.67 to 1.20, and -0.74 (95% CI -3.78 to 2.30) respectively). CONCLUSIONS: This meta-analysis did not confirm that energy equipment improved the SF of women with UI.

Acceptance rate of post-placental plac ement of intrauterine devices during the SARS-CoV-2 (COVID-19) pandemic.

OBJECTIVE: To evaluate the acceptance rate of post-placental intrauterine device (PPIUD) placement during the SARS-CoV-2 (COVID-19) pandemic and to to assess factors associated with PPIUD acceptance. METHODS: A cross-sectional study was conducted between August 2020 and August 2021. PPIUDs were offered to women scheduled for caesarean delivery or admitted in labour at the Women's Hospital of the University of Campinas. The study compared women according to whether they accepted or did not accept the IUD placement. The factors associated with PPIUD acceptance were analysed through bivariate and multiple logistic regression analyses. RESULTS: We enrolled 299 women (15.9% of the deliveries that occurred during study period), aged 26.8 ± 6.5 years; 41.8% were White, almost one third were primiparous, and 155/299 (51.8%) had a vaginal delivery. The PPIUD acceptance rate was 65.6%. The principal reason for refusal was the desire for another contraceptive (41.8%). Women with the highest likelihood of accepting a PPIUD were younger (<30 years old has 1.7 more likely or 74% greater), those without a partner (3.4 times more likely) and those after vaginal delivery (1.7 times more likely or 69% greater). CONCLUSION: The COVID-19 does not affected the PPIUD placement. PPIUD is a viable alternative during crisis in which women has difficult to access health services. Younger women, those without a partner and after vaginal delivery were more likely to accept a PPIUD during the COVID-19 pandemic.

Post-placental IUDs are an alternative during periods of crisis like the COVID-19 pandemic. Younger women, those without a partner and after vaginal delivery were more likely to accept a PPIUD during the COVID-19 pandemic.

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.

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.

One-year follow-up of immediate postpartum contraceptive implant insertion in adolescents.

PURPOSE: Our study aimed to evaluate the acceptability, adverse effects and continuation rates among adolescents who accepted the etonogestrel (ENG) subdermal implant and compared to adolescents who chose other methods during the immediate postpartum period before hospital discharge, with one year follow-up up. MATERIALS AND METHODS: We conducted a cohort non-randomised study at the Women's Hospital, University of Campinas. All women up to 19 years of age, who gave birth at the hospital between July 2019 and April 2020, were invited to participate and were offered the ENG-implant or the routine contraceptive methods. They were followed for one year postpartum. RESULTS: We included 100 teenagers and 72 accepted the ENG-implant. Students are more likely to accept the ENG-implant than non-students (PR: 1.25 [95%CI 0.99-1.59]). Up to one year of follow-up, survival analysis showed that the time of adherence to the method was longer for the ENG-implant users (p = 0.0049). More than 90% of the adolescents were satisfied with the implant; however, five requested early removal due to menstrual irregularity and local discomfort. CONCLUSION: Provision ENG-implant for adolescents in the immediate postpartum demonstrated high acceptance and ensured effective contraception. After one year, most of them were satisfied, with a high continuation rate and without unplanned pregnancies.

Effect of Vaginal Stretching and Photobiomodulation Therapy on Sexual Function in Women With Pelvic Floor Myofascial Pain - A Randomized Clinical Trial.

BACKGROUND: Spasm or increased tonus of the pelvic floor muscles (PFM) can cause myofascial pain (MP), which may result in painful intercourse and sexual dysfunction. AIM: The effect of vaginal stretching (VS) with photobiomodulation therapy (PBMT) is compared to VS with sham PBMT in overall sexual function, rate and severity of painful intercourse at baseline and after treatment in women with pelvic floor MP. METHODS: A double-blind randomized clinical trial of 103 women with MP: 1 group received 10 sessions of VS with PBMT (4 Joules of near-infrared light-808 nm at 3 points), and the other group received VS with sham PBMT. OUTCOMES: Impact of treatment was measured by the number of women experiencing painful intercourse, Pain severity was measured by Visual Analog Scale and sexual function was assessed by the FSFI questionnaire. Variables were assessed at baseline and after ten sessions in the intervention groups. RESULTS: After treatment, the number of women experiencing painful intercourse was significantly lower in both the VS with PBMT group (90.2-55%, P = .001), and VS with sham PBMT group (86.6-46.2%, P < .001). There was a significant reduction in pain measure by Visual Analog Scale (P < .001, [VS with PBMT group: P = .002; VS with sham PBMT group: P < .001]). There was a significant decrease in the number of participants with sexual dysfunction (FSFI score ≤26.55) after the treatment in the VS with PBMT group (92.2-74.5%, P = .003) and in the VS with sham PBMT group (90.4-76.9%, P = .035). Both groups showed improvement in the FSFI pain domain after treatment (P < .001, [VS with PBMT group: P = .038; VS with sham PBMT group: P = .005]). Only the VS with sham PBMT group had a significant increase in FSFI desire and total score (P < .001) after treatment. CLINICAL IMPLICATIONS: We found that VS associated or not with PBMT may be effective in reducing complaints of painful intercourse, alleviating pain severity, and reducing the number of women with pelvic floor MP suffering from sexual dysfunction. STRENGTHS & LIMITATIONS: Strengths of this study are the randomized design and use of validated questionnaires. Limitation of the study is the lack of a long follow-up period and the lack of a usual care comparison group hampers generalizability of the results. CONCLUSION: VS only and VS with PBMT have short-term efficacy in reducing painful intercourse and reducing a number of women with sexual dysfunction. Frederice CP, de Mira TAA, Machado HC, et al. Effect of Vaginal Stretching and Photobiomodulation Therapy on Sexual Function in Women With Pelvic Floor Myofascial Pain - A Randomized Clinical Trial. J Sex Med 2022;19:98-105.

Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The efficacy of radiofrequency (RF) in stress urinary incontinence (SUI) is as yet unknown. The aim was to compare the effect of fractional microablative RF and pelvic floor muscle training (PFMT) against the combination of both therapies (RF + PFMT) in the SUI and on genitourinary syndrome (GSM). METHODS: This was a three-arm randomized clinical trial including 117 climacteric women with SUI. In group 1 the treatment consisted of three monthly sessions of RF; in group 2 it was 12 weekly PFMT sessions; in group 3 it was RF + PFMT simultaneously. Assessments at baseline and 30 days after the end of therapy were conducted using validated questionnaires and scales for urinary, vaginal, and sexual functions and cytology for vaginal trophy. RESULTS: Urinary scores improved significantly in all three groups post-treatment (p < 0.001) with a higher improvement in the RF + PFMT group (p = 0.002). One-hour pad test results were equal in the three groups. Vaginal symptoms showed an incremental improvement in RF (p < 0.007), and vaginal laxity showed a similar improvement in the three groups (p = 0.323). Vaginal Health Index score was more significant in RF and RF + PFMT groups. Sexual function improved in RF and PFMT. CONCLUSIONS: The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed greater improvement in the RF treatment and vaginal laxity showed similar improvement in the three groups. The combination of RF and PFMT in sexual function did not show benefits superior to those achieved by the therapies alone.

Depression, anxiety, and stress in women with urinary incontinence with or without myofascial dysfunction in the pelvic floor muscles: A cross-sectional study.

AIMS: To compare the prevalence of psychological symptoms (depression, anxiety, and stress) in women with urinary incontinence (UI), according to the presence or absence of myofascial dysfunction (MD) in the pelvic floor muscles (PFMs). METHODS: Cross-sectional study, with women with UI who are 18 years old and over. The diagnosis of MD was defined by the pain of any intensity during the palpation of PFM. All participants answered the International Consultation on Incontinence Questionnaire-Short Form and the International Consultation on Incontinence Questionnaire Overactive Bladder for urinary symptoms and the Depression Anxiety and Stress Scale-Short Form-21 to check for the presence and degrees of depression, anxiety, and stress. RESULTS: Two hundred-thirty-four women with a mean age of 52.5 (±9.2) years were included. Almost half (51.7%) of women had MD. Women with MD showed higher mild and moderate anxiety scores (p = .005) and higher mild, moderate, and severe stress scores (p = .027) than women without MD. Depression scores were not associated with MD; however, women with and without MD reported severe or extremely severe depression, anxiety, and stress. CONCLUSIONS: The risk for depression, anxiety, and stress is high among women with UI regardless of the presence of MD. However, women with MD had higher scores for anxiety and stress than women with UI without MD.

One-year follow up on post-placental IUD insertion: A randomized clinical trial.

INTRODUCTION: Our objectives were to compare the 1-year follow-up clinical performance of the TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52-mg intrauterine system (IUS) inserted at post-placental period. MATERIAL AND METHODS: We conducted an open-label, parallel-group, randomized clinical trial, 1:1 with pregnant women admitted for childbirth independently of the mode of birth. Our primary outcome was expulsion up to 1 year after device placement by type of IUD and mode of delivery. During the follow up (42, 90 and 365 days (±7 days) after device placement), an ultrasound was performed to evaluate the device position. Kaplan-Meier with log-rank test was used to compare the survival curves of the TCu380A IUD and the LNG IUS. Couple-Years of Protection after insertion of both devices was calculated. RESULTS: One hundred and forty women were randomized to the TCu380A IUD (n = 70) or the LNG IUS (n = 70). By the end of the first year after device placement, 38 women experienced device expulsion (27.1%), most of them (33/38; 86.8%) within the first 42 days after delivery. The expulsions were significantly higher among users of TCu380A IUD (39.4%) than among users of the LNG IUS (22.2%; P = .039), and among those with vaginal delivery (43.8%) than among women with cesarean delivery (15%; P = .003). The 1-year cumulative continuation rate was 64.2%, significantly higher for LNG IUS (73.1%) than for TCu380A IUD (54.4%; P = .03), and among women with cesarean delivery (77.6%) than for vaginal delivery (52%; P = .00). The post-placental IUD insertion provided 356.4 Couple-Years of Protection. CONCLUSIONS: Two-thirds of women who accepted a post-placental IUD placement still used the device 1 year after childbirth. However, expulsion was the most prevalent reason for discontinuation, mainly within 42 days after device placement. The expulsion rate was significantly higher among TCu380A IUD users and among women with vaginal delivery.

Practical training of health care providers in insertion of contraceptive implants: findings from two Brazilian centres.

BACKGROUND AND OBJECTIVES: Lack of information and myths or inadequate training of health care providers in the guidance and management of contraceptives could negatively affect choice and eventually continuation rates. Our objectives were to evaluate the impact of clinical and theoretical training of health care professionals on insertion and removal of etonogestrel (ENG)-implant regarding this contraceptive, including pre- and post-training knowledge about insertion and removal techniques, clinical characteristics, side effects and outcomes. MATERIAL AND METHODS: We conducted a cross-sectional study in which a questionnaire was sent to health care providers after they received clinical training in the management of ENG-implant. RESULTS: After training, 78.2% of the 139 participants initiated to offer and inserted up to 5 implants/month and 17.6% between 6 to 10/month. None of the interviewees reported having difficulty with insertions after training, and 87.9% reported feeling very confident for removal. CONCLUSION: Theoretical and practical training appeared important to prepare health care professionals, clarify doubts and promote higher rates of use of contraceptive implants in Brazil, contributing to reduce the rates of unintended pregnancies.

Intracervical block for levonorgestrel-releasing intrauterine system placement among nulligravid women: a randomized double-blind controlled trial.

BACKGROUND: Fear of pain during the insertion of intrauterine contraceptives is a barrier to using these methods, especially for nulligravidas. An intracervical block may be easier and more reproducible than a paracervical block; however, this intervention has not been evaluated in nulligravid women to reduce pain with intrauterine contraceptive insertion. OBJECTIVE: To evaluate whether a 3.6-mL 2% lidocaine intracervical block reduces pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas; and, in addition, to assess whether the intracervical block has any effect on the ease of device insertion and on the overall experience with the procedure. MATERIALS AND METHODS: In this randomized double-blind controlled trial, nulligravidas were block-randomized to 1 of 3 arms prior to 52-mg levonorgestrel-releasing intrauterine system insertion: 3.6-mL 2%-lidocaine intracervical block, sham injection (intracervical dry-needling), or no intervention. The primary outcome was pain at levonorgestrel-releasing intrauterine system insertion. Secondary outcomes were pain at tenaculum placement, ease of insertion (assessed by healthcare providers), and the overall experience with the procedure (pain with levonorgestrel-releasing intrauterine system insertion compared with expectations, discomfort level, wish to undergo another device insertion in the future, and recommendation of the procedure to others). Participants' pain was measured with a 10-cm visual analogue scale and a 5-point Faces Pain Scale. Pain was summarized into categories (none, mild, moderate, severe) and also analyzed as a continuous variable (mean and 95% confidence interval). Our sample size had 80% power (α = 0.05) to detect a 15% difference in pain score measured by visual analogue scale (mean [standard deviation] visual analogue scale score = 5.9 [2.0] cm) and an absolute difference of 20% in the proportion of women reporting severe pain at levonorgestrel-releasing intrauterine system insertion among groups. We used a χ2 test and a mixed-effects linear regression model. We calculated the number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion. RESULTS: A total of 302 women were randomized (99 to the intracervical block, 101 to the intracervical sham, and 102 to no intervention), and 300 had a successful device insertion. The intracervical block group had fewer women reporting severe pain than the other groups, both at tenaculum placement (intracervical block: 2% vs sham: 30.2% vs no intervention: 15.2%, P < .0001) and at levonorgestrel-releasing intrauterine system insertion (intracervical block: 26.5% vs sham: 59.4% vs no intervention: 50.5%, P < .0001). The mean (95% confidence interval) pain score reported at levonorgestrel-releasing intrauterine system insertion was lower in the intracervical block group than in the other groups (intracervical block: 4.3 [3.8-4.9] vs sham: 6.6 [6.2-7.0], P < .0001; intracervical block: 4.3 [3.8-4.9] vs no intervention: 5.8 [5.3-6.4], P < .0001). Women from the intracervical block group reported less pain than expected (P < .0001), rated the insertion as less uncomfortable (P < .0001), and were more willing to undergo another device insertion in the future (P < .01) than women in the other groups. The ease of insertion were similar among groups. The number needed to treat for the intracervical block to avert severe pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion was 2 and 4, respectively. CONCLUSION: A 3.6-mL 2% lidocaine intracervical block decreased pain at tenaculum placement and levonorgestrel-releasing intrauterine system insertion among nulligravidas. It also provided a better overall experience during the procedure.

Does sacrocolpopexy present heterogeneity in its surgical technique? A systematic review.

AIMS: Sacrocolpopexy (SCP) is an extensively studied and highly efficacious treatment for female pelvic organ prolapse (POP). We aimed to analyze the technical steps for performance of a SCP among all RCTs in the literature that compared it with different procedures, or that studied different routes for performing SCP. METHODS: Systematic review searching electronic databases for RCTs only. We extracted data for 13 points of interest; main outcomes were procedure standardization; depth of vaginal dissection; number of sutures in the vaginal wall; type of suture in the vaginal wall; type of mesh fixation to the sacrum; and type and shape of mesh used. RESULTS: Twenty-two RCTs were included. Most of them did not provide a full standardized description of the procedure steps. There was great heterogeneity in almost all steps of the operation, including the choice of materials for attaching the mesh to the vagina and sacrum-with both absorbable and non-absorbable sutures being used-and the extent of vaginal dissection for mesh fixation, with some studies dissecting only the apex, superficially, while others performed a full-length dissection. Choice of mesh material was more consensual, with polypropylene mesh being the most commonly used. CONCLUSIONS: SCP is a highly unstandardized procedure in the literature, albeit being used as a major comparator. Various RCTs compared alternative procedures with SCP, but the technical aspects have varied greatly, and studied outcomes could have been potentially influenced by these technical choices.

Does vaginal delivery cause more damage to the pelvic floor than cesarean section as determined by 3D ultrasound evaluation? A systematic review.

INTRODUCTION AND HYPOTHESIS: Pregnancy and delivery are well-established risk factors for pelvic floor dysfunction (PFD), but the physiopathology, such as the delivery route, is not well understood. This study evaluated the impact of delivery route on the pelvic floor muscles via 3D ultrasound. METHODS: This review is registered in the PROSPERO database. The criteria for inclusion were prospective studies with 3D translabial ultrasound assessment in primigravida women during pregnancy and postpartum published in English, Spanish or Portuguese between 1980 and 2016. We excluded studies that did not include the topic of urogenital hiatus measurement and literature reviews. The MeSH terms were obstetric delivery, postpartum period, labor, parturition, three-dimensional images, ultrasonography, pelvic floor, and pelvic floor disorders. RESULTS: The search retrieved 155 articles. After analysis, 6 articles were included. Four studies showed that vaginal delivery (VD) was associated with a larger hiatal area. One study associated the hiatal area with levator ani muscle (LAM) defects in VD. Four articles evaluated the bladder neck, 3 of which showed a significant increase in bladder neck mobility associated with VD and 1 showed decreased bladder neck elevation, not associated with the delivery mode; the first 3 articles all evaluated LAM injuries and showed an association between VD and LAM injury. Women who underwent VD presented defects of the puborectalis muscle. CONCLUSIONS: Vaginal delivery was associated with a higher number of LAM injuries, puborectalis defects, increased bladder neck mobility, and enlargement of the hiatal area.

Clinical and ultrasonographic evaluation of the pelvic floor in primiparous women: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: We used clinical examination and transperineal 3D/4D ultrasound (US) to evaluate pelvic floor muscles (PFM) after different delivery modes. METHODS: Women were surveyed using validated questionnaires. PFM were evaluated and classified according to the Modified Oxford Scale following 3D/4D transperineal US. For statistical analysis, Kruskal-Wallis, Mann-Whitney, chi-square, and Fisher exact tests were used. RESULTS: Fifty-three women were evaluated: 32 with previous vaginal delivery (VD) and 21 with cesarean section (CS) (8 nonelective and 13 elective). No significant difference among groups was observed regarding urinary incontinence (UI) after delivery (p = 0.39), loss of muscle strength referred by the patient (p = 0.48), or evaluated through digital examination (p = 0.87). No patient with elective CS had avulsion, with difference between VD and elective CS (p = 0.008). US evaluation identified no differences in bladder-neck elevation (p = 0.69) or descent (p = 0.65) , and no difference in genital hiatus size (p = 0.35), levator ani thickness (p = 0.35 -0.44), or presence of major or minor levator ani avulsion (p = 0.10). CONCLUSIONS: We evaluated primiparous women within 12 to 24 months of delivery and found that VD was associated with PFM avulsion. There was no difference among VD and nonelective or elective CS in symptomatology or other anatomic alterations evaluated through 3D/4D transperineal US.

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.