PEOPLE: Lifestyle and comorbidities as risk factors for pelvic organ prolapse-a systematic review and meta-analysis PEOPLE: PElvic Organ Prolapse Lifestyle comorbiditiEs.

INTRODUCTION AND HYPOTHESIS: The literature is scarce regarding the effects of comorbidities, clinical parameters, and lifestyle as risk factors for pelvic organ prolapse (POP). This study was performed to systematically review the literature related to body mass index (BMI), waist circumference, diabetes mellitus (DM), hypertension (HT), dyslipidemia, chronic constipation, smoking, chronic cough, occupation, and striae and varicose veins as determinants for POP. METHODS: Search terms in accordance with Medical Subject Headings were used in PubMed, Embase, LILACS, and the Cochrane Library. Clinical comparative studies between women with and without POP and containing demographic and/or clinical raw data related to lifestyle and/or comorbidities were included. The ROBINS-I (risk of bias in non-randomized studies of interventions) instrument was used. Fixed-effects and random-effects models were used for homogeneous and heterogeneous studies, respectively. RESULTS: Forty-three studies were included in the meta-analysis. BMI < 25 kg/m2 was found to be a protective factor for POP [OR 0.71 (0.51, 0.99); p = 0.04], and BMI > 30 kg/m2 was a risk factor for POP [OR 1.44 (1.37, 1.52); p < 0.00001]. Waist circumference (≥ 88 cm) was reported as a risk factor for POP [OR 1.80 (1.37, 2.38); p < 0.00001], along with HT [OR 1.18 (1.09, 1.27); p = 0.04], constipation [OR 1.77 (1.23, 2.54); p < 0.00001], occupation [OR 1.86 (1.21, 2.86); p < 0.00001], persistent cough [OR 1.52 (1.18, 1.94); p < 0.0001]), and varicose veins [OR 2.01 (1.50, 2.70); p = 0.12]. CONCLUSIONS: BMI < 25 kg/m2 is protective while BMI > 30 kg/m2 is a risk factor for POP. Large waist circumference, dyslipidemia, HT, constipation, occupation, persistent cough, and varicose veins are also determinants for POP.

A incontinência urinária nas fases de climatério e menopausa: Efeitos, Consequências e Aceitação / Urinary incontinence in the climacteric and menopause phases: Effects, Consequences and Acceptance

Este trabalho traz a reflexão, através de conhecimentos multidisciplinares, sobre a incontinência urinária em decorrência da menopausa. Conceitua, a critério de informação, as diferentes fases que compõem o período de finalização da menstruação, experenciadas pelo público feminino, mais especificamente o climatério, pré-menopausa, menopausa e pós-menopausa. A discussão tem o objetivo de encontrar alternativas de comunicação e interação com a mulher em menopausa e trabalhar todos os sintomas possíveis encontrados nesta fase da vida, para que ela perceba a importância e a necessidade de procurar ajuda médica, informações inerentes ao tema, para uma melhor qualidade de vida, saúde e segurança nas suas transformações físicas e psíquicas. Reflete-se também sobre a realidade da mulher, os efeitos e impactos da menopausa na vida dela e a incontinência urinária como efeito dessa passagem. Como elas enfrentam essa condição no dia a dia e a insegurança que carregam ao viverem esse momento de transformação e 'perdas' relacionadas. Por isso, os profissionais debatem sobre a importância da comunicação e da disseminação da informação como caminhos para auxiliar na compreensão desse público a tudo relacionado à condição de incontinência urinária, em especial na menopausa. Os temas também debatem sobre a rede de apoio e o papel de cada um na percepção das mulheres ao que elas devem fazer, como fazer e por que fazer os tratamentos preventivos ou remediativos. É ciclo natural da vivência da mulher, mas os sintomas e efeitos não podem ser naturalizados, por isso a necessidade de se entender o panorama da incontinência urinária, nível Brasil, na vida das mulheres em menopausa.(AU)

This work brings reflection, through multidisciplinary knowledge, on urinary incontinence due to menopause. It conceptualizes, at the discretion of information, the different phases that make up the period of completion of menstruation, experienced by the female public, more specifically the climacteric, pre-menopause, menopause and post-menopause. The purpose of the discussion is to find alternatives for communication and interaction with women undergoing menopause and to work on all the possible symptoms found in this phase of life, so that she realizes the importance and need to seek medical help, information inherent to the subject, for a better quality of life, health and safety in their physical and mental transformations. It also reflects on the reality of women, the effects and impacts of menopause on her life and urinary incontinence as an effect of this transition. How they face this condition on a daily basis and the insecurity they carry when experiencing this moment of transformation and related 'losses'. Therefore, professionals discuss the importance of communication and dissemination of information as ways to help this public understand everything related to the condition of urinary incontinence, especially in menopause. The themes also discuss the support network and the role of each one in the women's perception of what they should do, how to do it and why to do preventive or remedial treatments. It is a natural cycle of women's experience, but the symptoms and effects cannot be naturalized, hence the need to understand the panorama of urinary incontinence, at the level of Brazil, in the lives of women undergoing menopause.(AU)

Este trabajo trae la reflexión, a través del conocimiento multidisciplinario, sobre la incontinencia urinaria por menopausia. Conceptualiza, a criterio de la información, las diferentes fases que componen el período de finalización de la menstruación, experimentado por el público femenino, más específicamente el climaterio, la premenopausia, la menopausia y la posmenopausia. El propósito de la charla es encontrar alternativas de comunicación e interacción con la mujer en la menopausia y trabajar todos los síntomas posibles encontrados en esta etapa de la vida, para que ella se dé cuenta de la importancia y necesidad de buscar ayuda médica, información inherente al tema. , para una mejor calidad de vida, salud y seguridad en sus transformaciones físicas y mentales. También reflexiona sobre la realidad de la mujer, los efectos e impactos de la menopausia en su vida y la incontinencia urinaria como efecto de esta transición. Cómo enfrentan esta condición en el día a día y la inseguridad que cargan al vivir este momento de transformación y las 'pérdidas' relacionadas. Por lo tanto, los profesionales discuten la importancia de la comunicación y la difusión de información como formas de ayudar a este público a comprender todo lo relacionado con la condición de incontinencia urinaria, especialmente en la menopausia. Los temas también discuten la red de apoyo y el papel de cada uno en la percepción de las mujeres sobre lo que deben hacer, cómo hacerlo y por qué hacer tratamientos preventivos o curativos. Es un ciclo natural de la experiencia de la mujer, pero los síntomas y los efectos no se pueden naturalizar, de ahí la necesidad de comprender el panorama de la incontinencia urinaria, a nivel de Brasil, en la vida de las mujeres en fase de menopausia.(AU)

Preclinical Evaluation of the Tumorigenic and Immunomodulatory Properties of Human Bone Marrow Mesenchymal Stromal Cell Populations with Clonal Trisomy 5.

Cytogenetic aberrations may emerge in human mesenchymal stromal cells (MSC) during ex vivo expansion for cell therapy. We have detected clonal trisomy 5 in two distinct autologous MSC products expanded from bone marrow which, based on the current quality control criteria, could not be released for clinical use. Although a safety concern, it is still unclear to what extent recurrent aneuploidies detected in MSC products may affect the threshold for neoplastic transformation or the medicinal properties of these cells. We have carried out an exploratory preclinical study to evaluate these MSC products with clonal trisomy 5, regarding their oncogenic and immunomodulatory potential. Cell population growth in vitro was reduced in MSC cultures with clonal trisomy 5 compared with the population growth of their euploid MSC counterparts, based on a lower cumulative population doubling level, reduced cell proliferation index, and increased senescence-associated beta-galactosidase activity. Subcutaneous injection of clinically relevant amount of MSC population, either with or without clonal trisomy 5, did not generate tumors in immunodeficient mice within a follow-up period of six months. Most importantly, MSC population with clonal trisomy 5 kept immunomodulatory properties upon interferon gamma (IFNγ) licensing, displaying overexpression of IDO, CXCL9, CXCL10, and CXCL11, in a similar fashion than that of IFNγ-licensed euploid MSC. Our findings suggest that bone marrow MSC products with clonal trisomy 5 may retain their therapeutic potential, based on poor tumor initiating capability and preserved immunomodulatory potency. This preclinical evidence may further support the definition of release criteria of autologous MSC products for cell therapy under critical clinical scenarios. This trial is registered with Clinical Study registration number: RBR-29x2pr.

Senescence State in Mesenchymal Stem Cells at Low Passages: Implications in Clinical Use.

Mesenchymal stem cells (MSCs) are multipotent cells found in various tissues and are easily cultivated. For use in clinical protocols, MSCs must be expanded to obtain an adequate number of cells, but a senescence state may be instituted after some passages, reducing their replicative potential. In this study, we report a case where MSC derived from an elderly donor acquired a senescence state after three passages. The bone marrow was aspirated from a female patient submitted to a cell therapy for the incontinency urinary protocol; MSCs were cultivated with DMEM low glucose, supplemented with 10% autologous serum (AS) plus 1% L-glutamine and 1% antibiotic/antimycotic. Senescence analysis was performed by ß-galactosidase staining after 24 and 48 h. Controls were established using BM-MSC from healthy donors and used for senescence and gene expression assays. Gene expression was performed using RT-PCR for pluripotency genes, such as SOX2, POU5F1, NANOG, and KLF4. MSC telomere length was measured by the Southern blotting technique, and MSCs were also analyzed for their capacity to differentiate into adipocytes, chondrocytes, and osteocytes. The patient's MSC expansion using AS displayed an early senescence state. In order to understand the role of AS in senescence, MSCs were then submitted to two different culture conditions: 1) with AS or 2) with FBS supplementation. Senescence state was assessed after 24 h, and no statistical differences were observed between the two conditions. However, patients' cells cultured with AS displayed a higher number of senescence cells than FBS medium after 48 h (p = 0.0018). Gene expression was performed in both conditions; increased expression of KLF4 was observed in the patient's cells in comparison to healthy controls (p = 0.0016); reduced gene expression was observed for NANOG (p = 0.0016) and SOX2 (p = 0.0014) genes. Telomere length of the patient's cells was shorter than that of a healthy donor and that of a patient of similar age. Osteocyte differentiation seemed to be more diffuse than that of the healthy donor and that of the patient of similar age. MSCs could enter a senescence state during expansion in early passages and can impact MSC quality for clinical applications, reducing their efficacy when administered.

International Urogynecological Consultation (IUC): pathophysiology of pelvic organ prolapse (POP).

INTRODUCTION AND HYPOTHESIS: This manuscript is the International Urogynecology Consultation (IUC) on pelvic organ prolapse (POP) chapter one, committee three, on the Pathophysiology of Pelvic Organ Prolapse assessing genetics, pregnancy, labor and delivery, age and menopause and animal models. MATERIALS AND METHODS: An international group of urogynecologists and basic scientists performed comprehensive literature searches using pre-specified terms in selected biomedical databases to summarize the current knowledge on the pathophysiology of the development of POP, exploring specifically factors including (1) genetics, (2) pregnancy, labor and delivery, (3) age and menopause and (4) non-genetic animal models. This manuscript represents the summary of three systematic reviews with meta-analyses and one narrative review, to which a basic scientific comment on the current understanding of pathophysiologic mechanisms was added. RESULTS: The original searches revealed over 15,000 manuscripts and abstracts which were screened, resulting in 202 manuscripts that were ultimately used. In the area of genetics the DNA polymorphisms rs2228480 at the ESR1 gene, rs12589592 at the FBLN5 gene, rs1036819 at the PGR gene and rs1800215 at the COL1A1 gene are significantly associated to POP. In the area of pregnancy, labor and delivery, the analysis confirmed a strong etiologic link between vaginal birth and symptoms of POP, with the first vaginal delivery (OR: 2.65; 95% CI: 1.81-3.88) and forceps delivery (OR: 2.51; 95% CI: 1.24-3.83) being the main determinants. Regarding age and menopause, only age was identified as a risk factor (OR : 1.102; 95% CI: 1.02-1.19) but current data do not identify postmenopausal status as being statistically associated with POP. In several animal models, there are measurable effects of pregnancy, delivery and iatrogenic menopause on the structure/function of vaginal support components, though not on the development of POP. CONCLUSIONS: Genetics, vaginal birth and age all have a strong etiologic link to the development of POP, to which other factors may add or protect against the risk.

Predictors for long-term adherence to vaginal pessary in pelvic organ prolapse: a prospective study.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the rate of adherence to pessary treatment for pelvic organ prolapse (POP), to identify factors associated with long-term (longer than 1 year) use of vaginal pessaries in Brazilian women with POP and its impact on quality of life (QoL). METHODS: A prospective observational study assessed 247 consecutive women candidates for a pessary to manage symptomatic POP. Patients were fitted with a ring pessary and follow-up visits were performed at 1, 6, and 12 months. Pessary complications and reasons for discontinuation were recorded. Prolapse Quality of Life Questionnaire (P-QoL) was applied at baseline and after 1 year of treatment. We used a logistic regression model for the analyses, with p < 0.05 for significance. RESULTS: A total of 236 women were included in the study, of whom 110 (46.6%) maintained the pessary treatment for longer than 12 months. The main reason for pessary discontinuation was the patient opting for surgery (50.8%). Vulvovaginitis was the main long-term complication (44.5%), followed by vaginal ulceration (16.4%) and urinary urgency (10%). No prior hysterectomy (OR = 2.26; 95% CI 1.19-4.31), vaginal estrogen use (OR = 1.94; 95% CI 1.06-3.52), and mean age (OR = 1.03; 95% CI 1.01-1.06) were variables associated with long-term use of vaginal pessary (p < 0.05 for all). Total P-QoL score significantly changed with pessary use (519.1 at baseline and 260 after 12-month treatment, p < 0.00). CONCLUSIONS: Our study suggests that no prior hysterectomy, the local estrogen therapy, and age might be factors associated with use of a ring vaginal pessary for longer than 1 year. Long-term pessary users had a significant improvement in their quality of life.

Age and/or postmenopausal status as risk factors for pelvic organ prolapse development: systematic review with meta-analysis.

INTRODUCTION AND HYPOTHESIS: Age is named as a risk factor for pelvic organ prolapse (POP), despite not being the primary outcome for many observational studies. Postmenopausal status is another associated factor but has many confounders. We aimed to systematically review the role of age and/or postmenopausal status in POP development. METHODS: Systematic review addressing age and hormones, more specifically by postmenopausal status, from inception to March 2020 in four databases (PubMed, Embase, WOS, Cochrane Library). Quality of evidence was classified by the ROBINS-I classification for non-randomized studies. Experimental studies, animal studies, studies linking age with recurrent POP and case series were excluded. Effect estimates were collected from adjusted odds ratio plus 95% confidence intervals. Significance level was 5%. A discussion exploring mechanistic factors was also included. RESULTS: Nineteen studies (11 cross sectional, 6 cohort and 2 case control) were included for quantitative analysis. Only two studies presented a low overall risk of bias for age; most of the domains were of moderate risk. Every additional year was responsible for a 10% increase in the risk to develop POP (OR = 1.102 [1.021-1.190]; i2 = 80%, random analysis, p = 0.012). This trend was confirmed when age was dichotomized into a cutoff of 35 (p = 0.035) and 50 (p < 0.001) years. Although an increase in the risk for POP was noted in postmenopausal women, this did not reach statistical significance (OR = 2.080 [0.927-4.668], i2 = 0%, p = 0.076). CONCLUSION: Age is a risk factor for POP; postmenopausal status was not statistically associated with POP, prompting the need for further studies addressing this factor.

Pelvic floor muscle function differs between supine and standing positions in women with stress urinary incontinence: an experimental crossover study.

QUESTION: In women with stress urinary incontinence, how does pelvic floor muscle (PFM) function differ between supine and standing when assessed using manometry, vaginal palpation, dynamometry and electromyography? DESIGN: An experimental crossover study. PARTICIPANTS: A total of 101 women with stress urinary incontinence were included. INTERVENTION: The PFM evaluations were performed and compared in supine and standing positions. The participants were assigned to either Group 1 (assessments in supine followed by standing) or Group 2 (assessments in standing followed by supine). OUTCOME MEASURES: The primary outcome was the PFM pressure during the maximum voluntary contraction (MVC). Secondary outcomes were the measures of PFM pressure at rest; PFM function (PERFECT scheme); active and passive forces (dynamometry); and PFM electromyography (EMG) activity. RESULTS: The mean MVC pressure was significantly lower in standing (MD -7 cmH2O, 95% CI -10 to -4). The mean PFM resting pressure was higher in standing (7 cmH2O, 95% CI 5 to 10). Three measures of PFM function derived from vaginal palpation were better in supine than in standing. The PFM active and the passive forces measured using dynamometry were higher in standing (0.18 kgf, 95% CI 0.16 to 0.20). The resting EMG activity was higher in standing than in supine (MD 3.6 µV, 95% CI 2.6 to 4.5), whereas EMG activity during MVC was higher in supine than standing (MD -8.7 µV, 95% CI -12.5 to -4.8). CONCLUSION: The pressure and EMG activity during MVC, and PFM function were lower in standing. The resting pressure, the passive and active forces of the PFM and the resting EMG activity of the PFM were higher in standing.

Is there a correlation between a 20-min pad-test and subjective urine leakage amount?

INTRODUCTION AND HYPOTHESIS: The quantification of urinary incontinence (UI) is widely used in clinical practice to guide the prognosis and treatment, and the pad test is an inexpensive, quick, and easy tool to assess UI that has been used in studies in the literature. Another way to evaluate UI is the subjective urine leakage amount, but no studies have tried to correlate it with the 20-min pad test. Therefore, this study aimed to assess the correlation of the 20-min pad test with the subjective urine leakage amount and compare it with the pelvic floor function. METHODS: This is a cross-sectional study with a sample size of 72 participants. It evaluated pelvic floor muscle strength as well as the duration of symptoms and pad weight. It used mean, standard deviation, median, and 95% confidence interval. In addition, ANOVA, Kruskal-Wallis, and Spearman's correlation coefficient were used. The significance level was fixed at 5% (significant if P < 0.05). RESULTS: Only age was different between leakage volumes; participants who report greater UI volume were older than the participants who leaked less urine. There were no differences related to the duration of symptoms between different UI volumes and pad weights according to the subjective volume reported. Spearman's coefficient between pad weight and subjective volume of urine leakage was rs = 0.558 (P ≤ 0.0001), demonstrating a moderate positive correlation. CONCLUSIONS: There was a moderate correlation between the UI volume reported and the 20-min pad test. Additionally, no differences related to pelvic floor function were detected.

Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence-a study protocol for a RCT.

BACKGROUND: Stress urinary incontinence (SUI) is a subtype of urinary incontinence that occurs more commonly amongst women. The pelvic floor muscle training (PFMT) is considered the gold standard for treating SUI. Another technique called the Knack postulated that pre-contraction of the pelvic floor muscles (PFM) during activities of increasing intra-abdominal pressure prevents urinary loss. Currently, there are no studies supporting the Knack for the treatment of SUI. Thus, the aim of this study is to test the hypothesis that voluntary pre-contraction of PFM can treat SUI. For this purpose, the following parameters will be analysed and compared amongst (1) the Knack, (2) PFMT and (3) the Knack + PFMT groups: urine leakage as assessed by the pad test, urinary symptoms, muscle function, quality of life, subjective cure, adherence to exercises in the outpatient setting and at home and perceived self-efficacy of PFM exercises. METHODS: A single-centre, double-blind (investigator and outcome assessor) randomised controlled trial with a 3-month follow-up of supervised treatment and an additional 3 months of follow-up (unsupervised) for a total of 6 months of follow-up. Two hundred ten women with mild to moderate SUI will be included, aged between 18 and 70 years. To compare the primary and secondary outcome measures within and between the groups studied (before and after intervention), the ANOVA statistical test will be used. Primary and secondary outcome measures will be presented as mean, standard deviation, 95% confidence interval and median and minimum and maximum values. DISCUSSION/SIGNIFICANCE: This study closes a gap, as voluntary PFM pre-contraction (the Knack) has not yet been included in the physiotherapeutic treatment of SUI, and if shown successful could be implemented in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03722719 . Registered on October 29, 2018. Study protocol version 1. Was this trial prospectively registered? Yes Funded by: The present study did not receive funding. Anticipated completion date: The anticipated trial commencement and completion dates are October 2018 and October 2021, respectively. Provenance: Not invited. Peer reviewed. Human research ethics approval committee: Research Ethical Board of the Universidade Federal de São Paulo (UNIFESP), Brazil. Human research ethics approval number: 2.517.312.

Animal models for pelvic organ prolapse: systematic review.

INTRODUCTION AND HYPOTHESIS: We aimed to summarize the knowledge on the pathogenesis of pelvic organ prolapse (POP) generated in animal models. METHODS: We searched MEDLINE, Embase, Cochrane and the Web of Science to establish what animal models are used in the study of suggested risk factors for the development of POP, including pregnancy, labor, delivery, parity, aging and menopause. Lack of methodologic uniformity precluded meta-analysis; hence, results are presented as a narrative review. RESULTS: A total of 7426 studies were identified, of which 51 were included in the analysis. Pregnancy has a measurable and consistent effect across species. In rats, simulated vaginal delivery induces structural changes in the pelvic floor, without complete recovery of the vaginal muscular layer and its microvasculature, though it does not induce POP. In sheep, first vaginal delivery has a measurable effect on vaginal compliance; measured effects of additional deliveries are inconsistent. Squirrel monkeys can develop POP. Denervation of their levator ani muscle facilitates this process in animals that delivered vaginally. The models used do not develop spontaneous menopause, so it is induced by ovariectomy. Effects of menopause depend on the age at ovariectomy and the interval to measurement. In several species menopause is associated with an increase in collagen content in the longer term. In rodents there were no measurable effects of age apart of elastin changes. We found no usable data for other species. CONCLUSION: In several species there are measurable effects of pregnancy, delivery and iatrogenic menopause. Squirrel monkeys can develop spontaneous prolapse.

Vaginal Sacrospinous Ligament Fixation Using Tissue Anchoring System Versus a Traditional Technique for Women With Apical Vaginal Prolapse: A Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to compare the efficacy and safety of the tissue anchoring system (TAS) kit versus the traditional technique for sacrospinous ligament fixation (SSLF) to treat apical vaginal wall prolapse. METHODS: A prospective randomized controlled multicenter study of noninferiority involving women with apical prolapse (C-point≥+1). Primary outcome is surgical success as C-point≤-4 at the 1-year follow-up. Secondary outcomes are success according to the composite criteria as C-point≤-4, Ba-point ≤0, and Bp-point ≤0; POP-Q measures of the vaginal compartments; intraoperative findings, complications; reoperation rate; hospital stay; and quality of life and sexual functioning (PISQ-12). It was estimated that 50 individuals per group would yield an 80% power for a noninferiority margin of 15%. RESULTS: Ninety-nine women were randomized: TAS (n = 55) and traditional SSLF (n = 44). The groups' preoperative data were similar. Drop-out rate was 11% for 12-month follow-up. Success rates were 90% for TAS and 80% for traditional SSLF (P = 0.0006; absolute difference, 9.8%; 90% confidence interval, -5.2 to 24.8) with the sensivity analyses per-protocol considering only the subjects that completed the 12-month follow-up and 80% versus 73%, respectively (P = 0.0048; absolute difference, 7.3%; 90% confidence interval, -9.6 to 24.2) by sensivity analyses considering the total number of participants randomized and treated with drop-out cases as failure. We detected shorter intraoperative time to dissect and reach the SSL, shorter length of hospitalization, lower rates of urinary tract infection, and lower pain scores in the first 30 days postoperative in the TAS compared with the traditional SSLF groups (P < 0.05). There was an improvement in women's quality of life that did not differ between groups. CONCLUSIONS: The modified technique of SSLF using the TAS kit is noninferior to the traditional technique for the treatment of apical compartment in 12-month follow-up.

Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review.

INTRODUCTION AND HYPOTHESIS: The pandemic caused by coronavirus disease 2019 (COVID-19) increased the awareness and efforts to provide care from distance using information technologies. We reviewed the literature about the practice and effectiveness of the rehabilitation of the female pelvic floor dysfunction via telehealth regarding symptomatology and quality of life and function of pelvic floor muscles (PFM). METHODS: A bibliographic review was carried out in May 2020 in the databases: Embase, Medline/PubMed, LILACS and PEDro. A total of 705 articles were reviewed after the removal of duplicates. The methodological quality of the articles was evaluated by the PEDro scale. Two authors performed data extraction into a standardized spreadsheet. RESULTS: Four studies were included, two being randomized controlled trials. Among the RCTs, only one compared telehealth with face-to-face treatment; the second one compared telehealth with postal treatment. The other two studies are follow-up and cost analysis reports on telehealth versus postal evaluation. Data showed that women who received the intervention remotely presented significant improvement in their symptoms, such as reducing the number of incontinence episodes and voiding frequency, improving PFM strength and improving quality of life compared to women who had the face-to-face treatment. CONCLUSIONS: Telehealth promoted a significant improvement in urinary symptoms, PFM function and quality of life. Telehealth is still emerging, and more studies are needed to draw more conclusions. The recommendations of the governmental authorities, physical therapy councils and corresponding associations of each country also need to be considered.

The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 30 to 50% of women are unable to correctly perform pelvic floor muscle (PFM) contractions. For women to benefit from a pelvic floor muscle training (PFMT) programme for stress urinary incontinence (SUI), the awareness phase of PFMT cannot be omitted. The purpose of this study is to evaluate whether vaginal palpation together with verbal instructions about PFMs and body awareness techniques helps women with SUI learn how to correctly contract the PFMs and improve their functions. METHODS: This single-centre, double-blind randomized controlled trial with two intervention groups was designed following the standard protocol items for randomized interventional trials (SPIRIT). The results will be reported in a manner consistent with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Patients with SUI (n = 172) will be recruited. The experimental group will receive verbal instructions about PFM function and body awareness techniques together with vaginal palpation; the control group will receive similar protocol without vaginal palpation. The primary outcome includes the number of fast-twitch muscle fibres assessed by vaginal palpation and visual observation. Secondary outcomes include power and muscular endurance that will be assessed by visual observation and vaginal palpation (Oxford scale), the use of accessory muscles during the voluntary contraction of PFMs, and the self-efficacy and the expectations for the results using the self-efficacy scale of pelvic floor exercises. DISCUSSION: This study will determine whether vaginal palpation can help women with SUI to correctly perform PFM contractions and improve their functions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03325543 . Registered on 30 November 2017. Study protocol version 1; 30 November 2020. Prospectively registered.

Ability to contract the pelvic floor muscles and association with muscle function in incontinent women.

INTRODUCTION AND HYPOTHESIS: Many women with pelvic floor dysfunction are unable to perform pelvic floor muscle (PFM) contraction. We aimed to assess the ability to contract the PFM and to evaluate the association with muscle function in Brazilian women with urinary incontinence. METHODS: We conducted a retrospective cross-sectional study including incontinent women over the age of 18. The assessment of PFM contraction was carried out by bidigital palpation via the PERFECT scheme. We categorized our population as: group absent: women not able to contract the PFM with verbal instructions; group 1 (1st command): women able to contract their PFM after verbal instructions; group 2 (2nd command): women who needed additional training on PFM anatomy and functioning to contract them. We compared the groups regarding their PFM functionality. We used ANOVA for demographic data and Mann-Whitney test for association analyses and P value < 0.05 for statistical significance. RESULTS: Among 139 women included, 21 (15.1%) were not able to perform the contraction of the PFM. Sixty-five (46.7%) contracted their PFM voluntarily at the first command and 53 (38.1%) at the second command. There was a significant reduction in the PFM function in group 2 in terms of power (p < 0.001), endurance (p < 0.001) and fast contraction (p < 0.001) compared to group 1. CONCLUSION: A high percentage (53.2%) of women were not able to contract their PFM voluntarily without training in PFM anatomy and functioning. Those women had impaired muscle function compared to women able to perform PFM after receiving exclusively oral instructions.

Content and functionality features of voiding diary applications for mobile devices in Brazil: a descriptive analysis.

INTRODUCTION AND HYPOTHESIS: A voiding diary is a method to investigate lower urinary tract symptoms. The purpose was to elaborate a descriptive analysis of nonpaid voiding diaries for mobile applications and to compare them regarding their quality. METHODS: We searched the platforms of iTunes (Apple Inc., Brazil) and Google Play (Google Inc., Brazil) using the keywords: "voiding diary," "bladder diary," "urinary diary," "urinary incontinence," and "pelvic floor." Inclusion criteria were: apps free of charge and specific for voiding diaries in the Portuguese, Spanish, French, or English language. Exclusion criteria were: access or technical problems and pediatric apps. We quantitatively analyzed and compared the apps with each other according to their functionality features and voiding diary topics (type and volume of fluid intake, voiding episodes and volume, type and episodes of incontinence, amount of leakage, urgency, and use of pads and nocturia). We rated the apps using the Mobile App Rating Scale (MARS), whose scores for each feature vary from 1 (worst score) to 5 (best score). RESULTS: Fifty-five apps were eligible; 16 were included for analyses. None presented all 11 topics of the voiding diary, and the median number of available features was 6 (3.75-7). "Incontinence episodes" was present in eight apps, and "nocturia" was present in five. The mean score of apps ranged between 1.7 and 4.5. CONCLUSION: There is variation in the content of voiding topics among the apps. Patients and professionals should choose the app based on the topics of most or particular interest.

Pelvic floor muscle training for female stress urinary incontinence: a randomised control trial comparing home and outpatient training.

INTRODUCTION AND HYPOTHESIS: In the literature, it is suggested that supervised pelvic floor muscle training (PFMT) might be the first option treatment for female stress urinary incontinence (SUI). However, inadequate accessibility to health care and scarce individual resources may prevent adherence to the treatment. Our study is aimed at comparing the efficacy of performing PFMT in an outpatient clinic and at home in Brazilian incontinent women, and to verify if home PFMT may be an alternative to those not able to attend the outpatient sessions. METHODS: A total of 69 women with predominant SUI were randomised into two groups: outpatient PFMT and home PFMT. The primary outcome was the cure of SUI defined as <2 g of leakage in a 20-min pad test. Secondary outcomes were: pelvic floor muscle function; urinary symptoms; quality of life; patient satisfaction; and adherence to home exercise sets. The assessments were conducted at baseline and after 3 months of treatment. Statistical analyses consisted of Student's t, Mann-Whitney U, Chi-squared, and Wilcoxon tests, with a 5% cut-off for significance. RESULTS: A superior objective cure of SUI was observed in the outpatient clinic (62%) compared with the home (28%) PFMT groups (OR: 4.0 [95% CI: 1.4-11.0]; p = 0.011). Secondarily, there was no difference between groups regarding the following: satisfaction with the treatment; quality of life; function of the PFMs; and number of episodes of urine leakage per week. The home adherence to the exercises was superior in the outpatient PFMT group only during the first-month training. CONCLUSIONS: Outpatient PFMT was associated with a higher objective cure of SUI than home PFMT. However, subjective findings show equal benefit of home PFMT providing evidence that this may be an alternative treatment to our population.

Pelvic floor symptoms 5 to 14 years after total versus subtotal hysterectomy for benign conditions: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: We aim to compare total versus subtotal abdominal hysterectomy regarding urinary and bowel symptoms and pelvic organ prolapse at long-term follow-up. METHODS: A systematic literature search was performed on the MEDLINE, LILACS, Cochrane CENTRAL and SCOPUS databases and conference abstracts (AAGL, AUGS, ICS) from inception up to November 2017. We included randomized trials comparing total versus subtotal hysterectomy for benign conditions that evaluated pelvic floor symptoms over 5 years of follow-up. Risk of bias and GRADE assessment for quality of evidence were performed. RESULTS: We included four studies involving 566 participants with follow-up ranging from 5 to 14 years. Women who underwent total hysterectomy presented lower risk of reported urinary incontinence [RR 0.74 (CI = 0.58, 0.94) i2 0%; p = 0.02] and stress urinary incontinence [RR 0.84 (CI = 0.71, 0.99) i2 0%; p = 0.04] than those who had subtotal hysterectomy. The events urinary frequency, urge incontinence, incomplete bladder emptying, pelvic organ prolapse, incontinence of stool and constipation did not favor one procedure over another in the long term (P > 0.05). CONCLUSIONS: Patient-reported urinary incontinence and stress urinary incontinence events favored total hysterectomy over subtotal hysterectomy up to 14-year long-term follow-up.

Outpatient biofeedback in addition to home pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.

AIMS: To test if biofeedback (BF) added to pelvic floor muscle training (PFMT) increases the frequency of home exercises performed by women with stress urinary incontinence (SUI). METHODS: 72 incontinent women were randomized to BF (outpatient BF + home PFMT) or PFMT (outpatient PFMT + home PFMT) groups. ASSESSMENTS: baseline, after 3 months of supervised treatment, at 9-month follow-up (after six additional months of home PFMT only). PRIMARY OUTCOME: frequency of monthly exercises sets performed (exercise diary) after 3-month treatment. SECONDARY OUTCOMES: adherence, urinary symptoms, severity and cure of SUI (pad test <2 g leakage), muscle function, quality of life, and subject cure (satisfaction report with no desire for different treatment) at the two time-points. STATISTICAL ANALYSES: ANOVA and Student's t-test with 5% cut-off for significance. RESULTS: It was observed similar frequency of monthly home exercises sets performed by BF (67.9 out of 82) and PFMT (68.2 out of 82) groups at 3 months. Secondarily, equal satisfaction, but superior objective cure of SUI for BF group after 3-month treatment (P = 0.018; OR: 3.15 [95% CI: 1.20-8.25]). At 9-month follow-up, the adherence to home exercises was similar (around 50%) and significantly dropped in both groups compared to the 3-month results (around 85%). No difference was detected in the objective and subjective cure of SUI between the groups after 9 months. Both therapies similarly improved the muscle function and quality of life during the study (P < 0.005). CONCLUSIONS: Adjunct BF did not increase the frequency of home exercises performed by SUI patients.