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.

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.

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.

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.

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.

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.

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.

Fecal incontinence or pelvic organ prolapse among women with premature ovarian insufficiency

Objectives: To assess the status of the pelvic floor muscle (PFM) of premature ovarian insufficiency women (POI women) and the incidence of fecal incontinence (FI) and pelvic organ prolapse (POP). Methods: A secondary analysis of a cross-sectional study with 150 women with POI was performed. Pelvic floor muscle assessment was performed with the PERFECT scale. The subscales POPDI-6 and CRADI-8 of the questionnaire Pelvic Floor Distress Inventory-20 (PFDI-20) were used for pelvic floor symptoms focused on FI and POP. Moreover, FI and POP were also assessed as dichotomous variables (yes/no). Results: Women with FI and POP did not present differences in the PFM assessment across P (p = 0.61), E (p = 0.78), R (p = 0.22), and F (p = 0.79) variables when compared with women with POI; no differences were also seen between women with and without POP according the pelvic muscles: P (p = 0.91), E (p = 0.99), R (p = 0.62), and F (p = 0.10). Women with FI and POP presented higher scores in all PFDI-20 subscales and total score when compared with the control group (p < 0.05). Conclusions Pelvic floor muscle assessment within POI women with or without FI or POP did not differ. However, PF symptoms are more severe in the FI or POP groups. (AU)

Experience of a Tertiary Service in the Treatment of Women with Cervical Pregnancy.

OBJECTIVE: Cervical pregnancy is challenging for the medical community, as it is potentially fatal. The treatment can be medical or surgical; however, there are no protocols that establish the best option for each case. The objective of the present study was to describe the cases of cervical pregnancy admitted to a tertiary university hospital over a period of 18 years. METHODS: A retrospective study based on a review of the medical records of all cervical pregnancies admitted to the Women's Hospital at Universidade Estadual de Campinas, Southeastern Brazil, from 2000 to 2018. RESULTS: We identified 13 cases of cervical pregnancy out of a total of 673 ectopic pregnancies; only 1 case was initially treated with surgery because of hemodynamic instability. Of the 12 cases treated conservatively, 7 were treated with single-dose intramuscular methotrexate, 1, with intravenous and intramuscular methotrexate, 1, with intravenous methotrexate, 1, with 2 doses of intramuscular methotrexate, and 2, with intra-amniotic methotrexate. Of these cases, one had a therapeutic failure that required a hysterectomy. Two women received blood transfusions. Four women required cervical tamponade with a Foley catheter balloon for hemostasis. There was no fatal outcome. CONCLUSION: Cervical pregnancy is a rare and challenging condition from diagnosis to treatment. Conservative treatment was the primary method of therapy used, with satisfactory results. In cases of increased bleeding, cervical curettage was the initial treatment, and it was associated with the use of a cervical balloon for hemostasis.

OBJETIVO: A gravidez ectópica cervical é um desafio para a comunidade médica, pois pode ser fatal. O tratamento pode ser clínico ou cirúrgico, mas não existem protocolos que estabeleçam a melhor opção para cada caso. O objetivo deste estudo foi descrever os casos de gravidez ectópica cervical internados em um hospital universitário terciário durante 18 anos. MéTODOS: Estudo retrospectivo com revisão de prontuários de todas as gestações ectópicas cervicais internadas no Hospital da Mulher da Universidade Estadual de Campinas de 2000 a 2018. RESULTADOS: Foram identificados treze casos de gestação ectópica cervical em um total de 673 gestações ectópicas; apenas 1 caso foi inicialmente tratado com cirurgia por causa de instabilidade hemodinâmica. Dos 12 casos tratados conservadoramente, 7 foram tratados com metotrexato por via intramuscular em dose única, 1, com metotrexato pelas vias intravenosa e intramuscular, 1, com metotrexato por via intravenosa, 1, com 2 doses de metotrexato por via intramuscular, e 2, com metotrexato por via intra-amniótica. Desses casos, um apresentou falha terapêutica, e realizou-se uma histerectomia. Duas mulheres receberam transfusões de sangue. Quatro mulheres necessitaram de tamponamento cervical com cateter balão de Foley para hemostasia. Não houve casos fatais. CONCLUSãO: A gravidez cervical é uma condição rara e desafiadora desde o diagnóstico até o tratamento. O tratamento conservador foi o principal método terapêutico utilizado, com resultados satisfatórios. Nos casos de sangramento aumentado, a curetagem cervical foi o tratamento inicial, e foi associada ao uso de balão cervical para hemostasia.

Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth-a protocol for a randomized clinical trial.

BACKGROUND: Ensuring effective and long-term contraception in the immediate postpartum period is an effective strategy for reducing unplanned pregnancies. In the meantime, the intrauterine device (IUD) is an excellent option. The aim of our study was to evaluate the best way to insert post-placental IUDs in the immediate postpartum period. Discomfort during insertion, expulsion rate, uterine perforation rate, and proper positioning 40-60 days postpartum will be analyzed. METHODS: Randomized, controlled, open clinical trial. The study group will be composed of women between 18 and 43 years old who are admitted for vaginal birth at the Women's Hospital of the State University of Campinas and who wish to use the IUD as a contraceptive method. The sample will be randomized into two insertion groups: manual and forceps. To calculate the sample size, the method of comparing the proportion between 2 groups was used, setting the level of significance alpha at 5% (alpha=0.05) and the power of the sample at 80% (beta=0.20). Based on the results, it was estimated that a sample of n=186 women (n=93 with manual insertion and n=93 with forceps) would be representative for comparison of expulsion between the 2 groups. All participants will undergo a postpartum consultation 40-60 days after birth with transvaginal ultrasound to assess the proper placement of the IUD. DISCUSSION: Insertion of an IUD in the immediate postpartum period has been considered a good option to increase coverage and access to contraception, and its benefit outweighs the inconvenience of a higher expulsion rate. TRIAL REGISTRATION: This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 50497321.4.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC) (number RBR-4j62jv6). This is the first version of the study protocol approved on 11/12/2021 prior to the start of participant recruitment.

Experience of a Tertiary Service in the Treatment of Women with Cervical Pregnancy / Experiência de um serviço terciário no tratamento de mulheres com gravidez ectópica cervical

Abstract Objective Cervical pregnancy is challenging for the medical community, as it is potentially fatal. The treatment can be medical or surgical; however, there are no protocols that establish the best option for each case. The objective of the present study was to describe the cases of cervical pregnancy admitted to a tertiary university hospital over a period of 18 years. Methods A retrospective study based on a review of the medical records of all cervical pregnancies admitted to the Women's Hospital at Universidade Estadual de Campinas, Southeastern Brazil, from 2000 to 2018. Results We identified 13 cases of cervical pregnancy out of a total of 673 ectopic pregnancies; only 1 case was initially treated with surgery because of hemodynamic instability. Of the 12 cases treated conservatively, 7 were treated with single-dose intramuscular methotrexate, 1, with intravenous and intramuscular methotrexate, 1, with intravenous methotrexate, 1, with 2 doses of intramuscular methotrexate, and 2, with intra-amniotic methotrexate. Of these cases, one had a therapeutic failure that required a hysterectomy. Two women received blood transfusions. Four women required cervical tamponade with a Foley catheter balloon for hemostasis. There was no fatal outcome. Conclusion Cervical pregnancy is a rare and challenging condition from diagnosis to treatment. Conservative treatment was the primary method of therapy used, with satisfactory results. In cases of increased bleeding, cervical curettage was the initial treatment, and it was associated with the use of a cervical balloon for hemostasis.

Resumo Objetivo A gravidez ectópica cervical é um desafio para a comunidade médica, pois pode ser fatal. O tratamento pode ser clínico ou cirúrgico, mas não existem protocolos que estabeleçam a melhor opção para cada caso. O objetivo deste estudo foi descrever os casos de gravidez ectópica cervical internados em um hospital universitário terciário durante 18 anos. Métodos Estudo retrospectivo com revisão de prontuários de todas as gestações ectópicas cervicais internadas no Hospital da Mulher da Universidade Estadual de Campinas de 2000 a 2018. Resultados Foram identificados treze casos de gestação ectópica cervical em um total de 673 gestações ectópicas; apenas 1 caso foi inicialmente tratado com cirurgia por causa de instabilidade hemodinâmica. Dos 12 casos tratados conservadoramente, 7 foram tratados com metotrexato por via intramuscular em dose única, 1, com metotrexato pelas vias intravenosa e intramuscular, 1, com metotrexato por via intravenosa, 1, com 2 doses de metotrexato por via intramuscular, e 2, com metotrexato por via intra-amniótica. Desses casos, um apresentou falha terapêutica, e realizou-se uma histerectomia. Duas mulheres receberam transfusões de sangue. Quatro mulheres necessitaram de tamponamento cervical com cateter balão de Foley para hemostasia. Não houve casos fatais. Conclusão A gravidez cervical é uma condição rara e desafiadora desde o diagnóstico até o tratamento. O tratamento conservador foi o principal método terapêutico utilizado, com resultados satisfatórios. Nos casos de sangramento aumentado, a curetagem cervical foi o tratamento inicial, e foi associada ao uso de balão cervical para hemostasia.

Cross-cultural adaptation and validation of the Brazilian Portuguese version of the Female Sexual Distress Scale-Revised questionnaire for women with vaginal laxity.

INTRODUCTION AND HYPOTHESIS: Vaginal laxity (VL) can impair women´s quality of life and there are not many tools aimed at quantitatively addressing this complaint. Sexual distress can be present within this group of patients. The aim of our study is to carry out the cross-cultural adaptation/translation and validation of the Female Sexual Distress Scale-Revised (FSDS-R) for Brazilian Portuguese women with VL. METHODS: Women age ≥ 18 years, with VL (n=82), and without VL (n=53) were included. Continuous variables were described in the form of mean/standard deviation or median/range, and Student's t test was used. The Chi-squared test was used for dichotomous variables. Cronbach's alpha coefficient was used for internal consistency and Spearman's correlation was used to assess construct validity (FSDS-R, Female Sexual Function Index [FSFI], and Incontinence Questionnaire Vaginal Symptoms [ICIQ-VS]). A significance level of 5% was established using a two-tailed test. RESULTS: Women with VL presented more anal/vaginal sexual intercourse than women without VL (p=0.030). All three instruments (FSDS-R, FSFI, and ICIQ-VS) presented discriminant validity between women with and without VL (p<0.001). A high internal consistency (Cronbach´s alpha =0.887) was found in women with VL and without VL (0.917). Regarding construct validity (n=82), there was a strong positive correlation between FSDS-R score and ICIQ-VS scales, except for a weaker correlation between the ICIQ-VS vaginal symptoms subscale (r: +0.2788; p=0.013). A moderate negative correlation was found between FSDS-R and all FSFI domains (p<0.001), except for pain (p<0.062). CONCLUSIONS: The Brazilian version of the FSDS-R showed adequate internal consistency and discriminant validity, and a correlation was found with other instruments such as FSFI and ICIQ-VS.

Measurement of the vaginal wall thickness by transabdominal and transvaginal ultrasound of women with vaginal laxity: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: An objective diagnostic method to understand vaginal laxity (VL) is still missing. The aim of our study is to determine whether vaginal wall thickness (VWT) measured by ultrasound may differ according to the abdominal or vaginal techniques and to assess whether clinical variables are associated with vaginal measurements of women with VL. METHODS: A cross-sectional study conducted at a tertiary hospital included 82 women aged ≥ 18 years with VL complaints assessed by the Vaginal Laxity Questionnaire. Women who reported severe comorbidities or vulvovaginal disorders, previous treatment for VL, and use of vaginal estrogen in the last 6 months were excluded. Participants reporting VL underwent transabdominal (TAUS) and transvaginal ultrasound (TVUS) and physical examination and answered validated questionnaires. Descriptive data were given as mean and standard deviation, median (range), and absolute and relative frequency. The significance level adopted for this study was 5%. Sample size calculation was not performed for the present study. RESULTS: Mean age was 41.20 ± 8.64 years, and most participants were multiparous, with previous vaginal delivery and having vaginal intercourse. A statistically significant difference (up to 3 mm) between TAUS and TVUS measurements of the VWT was found in the proximal, middle-third, and distal compartments. A significant correlation was found between VWT and TAUS or TVUS in the mid-third and distal compartments. CONCLUSION: A significant correlation was found between the VWT measurements in TVUS and TAUS. Our findings might give the health professional more possibilities for investigating VWT according to patient characteristics.

Vaginal stretching therapy and class IIIB vaginal laser treatment for pelvic floor myofascial pain: a randomized clinical trial.

PURPOSE: Several treatment options are proposed for the management of pelvic floor myofascial pain (PFMP). Manual therapy, such as vaginal stretching (VS), is one of these options. Photobiomodulation therapy (PBMT) with a laser device is a treatment option for PFMP that has been tested on other muscles. The aim of this study was to evaluate the effect of VS combined or not with PBMT for PFMP treatment. METHODS: One hundred three women with PFMP were enrolled in a double-blind randomized trial and assigned to VS+PBMT (10 treatments over 2 weeks with 100 mw delivering 12 joules to surface intravaginally, using near-infrared light 808 nm) and VS+shamPBMT treatment groups. Pain severity was assessed by Visual Analog Scale (VAS). Pelvic floor muscle function was assessed by Oxford Scale and surface electromyography. Urinary symptoms were evaluated by ICIQ-OAB and ICIQ-SF questionnaires, and intestinal constipation was assessed by ROMA criteria. RESULTS: There was a significant improvement in pain intensity (VAS) after treatment in both groups, with no difference between groups (p = 0.46). More than 50% of the women complained of severe pain before treatment, and after treatments, it was reported by less than 20% of women (p < 0.001), with no difference between groups (p = 0.08). Urinary symptoms improved in both groups (p < 0.001) with no difference between groups (p = 0.37). Intestinal constipation improved in the VS+PBMT group only (p = 0.01). CONCLUSION: VS and VS with near-infrared vaginal laser therapy were equally effective at decreasing myofascial pelvic pain and reducing urinary symptoms TRIAL REGISTRATION: REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under no.RBR-2TDCQ4 (November 11, 2018).

Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications.

INTRODUCTION AND HYPOTHESIS: Despite its frequent use, there is little evidence of adequate management of pessaries for treating pelvic organ prolapse (POP). Thus, the aims the study were to assess the rate of complications in women using ring-type pessaries with cleaning and monitoring every 6 months and to correlate the time of use of the pessary with possible complications. METHODS: This is a cross-sectional study including women diagnosed with stage 3 or 4 genital prolapse, who were already in outpatient follow-up and who used a ring pessary. We excluded patients using another type of pessary, with severe comorbidities and with POP-Q ≤ 2 staging. The chi-square test or Fisher exact test was applied for categorical variables, the t-test for continuous variables with normal distribution and Mann-Whitney test for non-parametric variables. RESULTS: A total of 83 women using a ring pessary were assessed. The mean in months of pessary use was 31.8 ± 14.9 months. Vaginal discharge was the most frequent complaint representing 26.5%, followed by foul smell in 13.3%. No significant correlation was found between length of pessary use and clinical variables. However, a significant correlation was found between immediate complications and the length of pessary use (21.3 ± 5.9 months; p < 0.0044). CONCLUSION: There was no increase in complication rate in the continuous use of a ring pessary with cleaning and monitoring every 6 months. Determining a follow-up time that reduces the risk of complications is necessary not only for the organization of the attendance services, allowing a greater number of monitored patients, but also for the access of patients who need regular monitoring.

Vaginal stenosis in women with cervical or endometrial cancer after pelvic radiotherapy: a cross-sectional study of vaginal measurements, risk for sexual dysfunction and quality of life.

INTRODUCTION AND HYPOTHESIS: Radiotherapy (RT) for cervical (CC) and endometrial cancer (EC) is known to lead to vaginal stenosis (VS), but the comparison between vaginal anatomical measurements and the risk of sexual dysfunction presents a wide variety of results among the literature. Thus, we sought to assess the prevalence of VS, vaginal measurements, sexual dysfunction and QOL in women with CC and EC submitted to pelvic RT with or without previous surgery. METHODS: Cross-sectional study that included 61 women with CC and 69 with EC. VS was classified by the Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0), sexual function by the validated Female Sexual Function Index (FSFI) and QOL by the validated World Health Organization questionnaire (WHOQOL-BREF). Acrylic cylinders were used for vaginal measurements. Uni-/multivariate analyses to address factors associated with VC in both groups were performed. RESULTS: The prevalence of VS was 79% and 67% within patients with CC and EC, respectively. Vagina length was decreased in both groups without statistical difference (7.2 ± 1.7 vs. 6.6 ± 1.8;p = 0.072). Vaginal diameter was significantly higher (p = 0.047) in women with EC (25.4 ± 6.3) than in those with CC (23.1 ± 5.7). Sexual dysfunction was highly prevalent for both CC and EC (88% vs. 91%; p = 0.598). There was no difference in all WHOQOL-BREF domains between women with CC and EC. CONCLUSIONS: VS is highly prevalent in CC and EC patients, with vaginal length decreased in both groups but with a higher vaginal diameter in those with EC. Nevertheless, sexual dysfunction is highly prevalent in both groups.

Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol.

BACKGROUND: Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity. METHODS/DESIGN: This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention). EXPECTED RESULTS: The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity. TRIAL REGISTRATION: Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).