An International Continence Society (ICS)/ International Urogynecological Association (IUGA) joint report on the terminology for the assessment and management of obstetric pelvic floor disorders.

AIMS: The terminology of obstetric pelvic floor disorders should be defined and reported as part of a wider clinically oriented consensus. METHODS: This Report combines the input of members of two International Organizations, the International Continence Society (ICS) and the International Urogynecological Association (IUGA). The process was supported by external referees. Appropriate clinical categories and a sub-classification were developed to give coding to definitions. An extensive process of 12 main rounds of internal and 2 rounds of external review was involved to exhaustively examine each definition, with decision-making by consensus. RESULTS: A terminology report for obstetric pelvic floor disorders, encompassing 357 separate definitions, has been developed. It is clinically-based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it usable by different specialty groups and disciplines involved in the study and management of pregnancy, childbirth and female pelvic floor disorders. Clinical assessment, investigations, diagnosis, conservative and surgical treatments are major components. Illustrations have been included to supplement and clarify the text. Emerging concepts, in use in the literature and offering further research potential but requiring further validation, have been included as an Appendix. As with similar reports, interval (5-10 year) review is anticipated to maintain relevance of the document and ensure it remains as widely applicable as possible. CONCLUSION: A consensus-based Terminology Report for obstetric pelvic floor disorders has been produced to support clinical practice and research.

Three-Dimensional Volume Rendering of Pelvic Floor Anatomy with Focus on Fibroids in Relation to the Lower Urogenital Tract Based on Cross-Sectional MRI Images.

We aimed to assess the feasibility of developing three-dimensional (3D) models of pelvic organs using cross-sectional MRI images of patients with uterine fibroids and urinary symptoms and of obtaining anatomical information unavailable in 2D imaging modalities. We also aimed to compare two image processing applications. We performed a feasibility study analysing MRI scans from three women, aged 30 to 58 years old, with fibroids and urinary symptoms. Cross-sectional images were used to render 3D models of pelvic anatomy, including bladder, uterus and fibroids, using 3D Slicer and OsiriX. Dimensions, volumes and anatomical relationships of the pelvic organs were evaluated. Comparisons between anatomical landmarks and measurements obtained from the two image processing applications were undertaken. Rendered 3D pelvic models yielded detailed anatomical information and data on spatial relationships that were unobtainable from cross-sectional images. Models were rendered in sufficient resolution to aid understanding of spatial relationships between urinary bladder, uterus and fibroid(s). Measurements of fibroid volumes ranged from 5,336 to 418,012 mm3 and distances between the fibroid and urinary bladder ranged from 0.10 to 83.60 mm. Statistical analysis of measurements showed no significant differences in measurements between the two image processing applications. To date, limited data exist on the use of 3D volume reconstructions of routine MRI scans, to investigate pelvic pathologies such as fibroids in women with urinary symptoms. This study suggests that post-MRI image processing can provide additional information over standard MRI. Further studies are required to assess the role of these data in clinical practice, surgical planning and training. Three-dimensional reconstruction of routine two-dimensional magnetic resonance imaging provides additional anatomical information and may improve our understanding of anatomical relationships, their role in clinical presentations and possibly guide clinical and surgical management.

Which patient reported outcomes (PROs) and patient reported outcome measures (PROMs) do researchers select in stress urinary incontinence surgical trials? - a systematic review.

INTRODUCTION AND HYPOTHESIS: The mesh controversy has highlighted the need for robust evidence of treatment safety and efficacy, particularly in the surgical treatment of stress urinary incontinence (SUI). Current trials demonstrate heterogeneity in outcomes reported as well as outcome measures used, restricting the ability to synthesize data and produce robust research evidence (Doumouchtsis et al. 5). Patient-reported outcomes (PROs) should be a focus when evaluating SUI surgery given the quality-of-life nature of this condition affecting 25-45% women worldwide (Milsom and Gyhagen 1). As part of the first step in developing a core outcome set (COS) and measures set (COMS), we aimed to systematically review RCTs evaluating SUI surgery and extract PROs and outcome measures (PROMs) used. MATERIALS AND METHODS: We searched databases including MEDLINE and Cochrane for RCTs evaluating SUI surgical treatments from inception to January 2020. Eligibility criteria included English language and female-only subjects. PROs and PROMs were extracted and grouped into a structured inventory. PROMs were assigned to domains based on predominant theme. RESULTS: Of 123 eligible RCTs, 116 (94%) included PROs. Forty-four different PROMs were utilized; most frequent was Patient Global Impression of Improvement (PGI-I). Fifteen PROMs were used once. The top five PROMs have evidence of validity and are highly recommended. CONCLUSIONS: There is no consensus amongst relevant stakeholders regarding PROs or PROMs used in SUI surgery research. We propose that this consensus is required to standardize measurements and reporting and promote use of validated and reliable outcome measures. This systematic review forms the first step in the development process.

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

Maternal and neonatal outcomes associated with delivery techniques for impacted fetal head at cesarean section: a systematic review and meta-analysis.

OBJECTIVES: Late first-stage or second-stage cesarean section is commonly associated with fetal head impaction, leading to maternal and neonatal complications. This situation requires safe delivery techniques, but the optimal management remains controversial. The aim of this meta-analysis was to compare maternal and neonatal outcomes associated with delivery techniques via cesarean section. METHODS: An electronic search of three databases, from inception to June 2021, was conducted. Cohort and randomised comparative studies on maternal and neonatal outcomes associated with techniques to deliver an impacted fetal head during cesarean section were included. The methodological quality of the primary studies was assessed. Review Manager 5.4 was used for statistical analyses. RESULTS: Nineteen articles, including 2,345 women were analyzed. Three fetal extraction techniques were identified. Meta-analyses showed that the "pull" technique carries lower risks as compared to the "push" technique and the "Patwardhan" technique is safer compared to the "push" or the "push and pull" technique. CONCLUSIONS: In the absence of robust evidence to support the use of a specific technique, the choice of the obstetrician should be based on best available evidence. Our study suggests that the "pull", as well as the "Patwardhan" technique represent safe options to deliver an impacted fetal head.

Vulvodynia: What is available online? A systematic review of information on the internet.

AIM: This review aimed to evaluate the quality of medicalinformation online for patients relating to vulvodynia. To our knowledge no evaluation of online patient information exists regarding vulvodynia and, at present, there is no standardized or validated method of evaluating medical information on the internet. METHODS: A clearly defined protocol was developed to generate keywords relating to vulvodynia. The three most popular search engines worldwide; google.com, yahoo.com, and bing.com, were searched in September 2020. Three assessors evaluated eligible webpages for accuracy, credibility, readability, and reliability. RESULTS: Forty-five webpages were eligible with 38% given HON certification or Information Standard approval. Only one webpage achieved a DISCERN score of ≥63 indicating excellent reliability. No webpages scored a maximum 10 points for credibility. Eleven percent of webpages were rated "accurate" with score 17 or above. The modal Flesch Kincaid Grade Level was 9 with only 15.6% having a readability grade level of 8 or less. CONCLUSIONS: It has been shown in previous studies that patient information available online pertaining to gynecological conditions is frequently inaccurate, with limited regulation and low reliability, and our findings are in agreement with this. As patients increasingly look to the internet for medical information and education, we as clinicians, need to ensure the resources available are of a high standard and regulated. Without ensuring safe and effective healthcare resources, we risk misinformation which can negatively impact clinical care.

Reversal of colpocleisis-A surgical technique for recurrent pelvic organ prolapse.

Given the rarity of recurrent pelvic organ prolapse after obliterative procedures and the paucity of data in the literature on this topic, optimal management is challenging. We describe a technique of reversal of colpocleisis in an 81-year-old woman with recurrent prolapse as the first step in a staged, reconstructive procedure. Basic principles underlying our approach include multidisciplinary team involvement, detailed preoperative planning, and a series of investigations including different imaging modalities and a meticulous stepwise surgical technique. The distortion of anatomical planes, anticipated scarring, and close proximity of pelvic organs specifically bladder and rectum are important considerations. In our case, the multidisciplinary surgical team included urogynecologists, a urologist, and a colorectal surgeon. Detailed preoperative planning was agreed following multiple patient and team consultations. Preoperative investigations included ultrasound and videourodynamics. Intraoperatively, cystoscopy and sigmoidoscopy were performed to identify anatomical landmarks and planes, rule out fistulae, and evaluate for anatomical distortions involving pelvic organs. Subsequently, reversal of the colpocleisis was undertaken and uneventful. Postoperative recovery was uncomplicated and a sacrospinous fixation, anterior vaginal repair, and perineorrhaphy were performed as a secondary restorative procedure for the correction of recurrent prolapse.

Impact of COVID-19 in gynaecological oncology care: a systematic rapid review.

PURPOSE: Synthesis of available evidence on clinical practice in gynaecological oncology during the COVID-19 pandemic is highly warranted, as women with cancer are at increased risk due to their systemic immunosuppressed state and changes in their care are inevitable. Rapid review of available data is a quick way of providing useful information and insight into the way medical practice has been affected by the COVID pandemic. METHODS: We conducted a systematic rapid review, based on a literature search of MEDLINE/PubMed, Embase, and Cochrane CENTRAL. We considered all studies on gynaecological oncology care during the COVID-19 pandemic using relevant keywords and MeSH terms. Selection criteria were English language, studies with more than five cases and publication in peer-review journal. RESULTS: Nine retrospective studies, one systematic review and five questionnaire surveys were included. Quality of the studies has been assessed. Development of higher quality evidence is warranted. Mortality of COVID-19 infection is higher in patients with gynaecological cancer than in non-cancer patients. Reported delays in diagnosis and management of cancer and changes in treatments, may affect the natural history of cancer and increase patients' anxiety and fear of disease progression while causing concerns to healthcare professionals affecting their clinical practice. The number of new diagnoses has declined. Prioritization is important, face-to-face interactions should be limited, and appropriate protective measures are essential. Cancer surgery, chemotherapy, and radiotherapy should continue as high priority practices. CONCLUSION: The COVID-19 pandemic has affected clinical practice significantly. Adaptations in clinical practice may improve mortality and complication rates.

A rapid systematic review of postpartum bladder care guidelines and recommendations in the context of the COVID-19 pandemic.

New pathways for the management of postpartum voiding dysfunction and postpartum urinary retention should be considered to shorten hospital stays and promote early discharge during the COVID-19 pandemic. This rapid systematic review aimed to identify relevant national and international guidelines, and summarise available recommendations on postpartum bladder care that are relevant to women's care and management at the time of the pandemic. We searched Medline, Embase and Cochrane from inception till September 2021. Hand-searching of national and international specialist societies' websites was performed. We identified one international technical consultation, one international society's report of recommendations and two national guidelines. Guidelines stated that postnatal women should not be left more than 6 hours without voiding and assessed for postpartum urinary retention. As the cut-off of 150 ml for the diagnosis of significant postvoid residual volume is commonly used with no reported adverse outcomes, it could be beneficial to adopt this instead of 100 ml as further unnecessary interventions can be avoided. Such changes can reduce the number of women staying in the hospital. Clean intermittent self-catheterisation for the management of postpartum urinary retention could be considered as an option during the COVID-19 pandemic aiming to shorten hospital stays and avoid further attendances. Optimised bladder care has become more relevant during the coronavirus pandemic by striving towards self-care, community-based and remote care. We propose consideration of intermittent self-catheterisation in cases of postpartum urinary retention enabling self-care and avoidance of hospital visits.

Systematic review and appraisal of clinical practice guidelines on pelvic organ prolapse using the AGREE II tool.

AIMS: To systematically evaluate the content and quality of national and international clinical guidelines on pelvic organ prolapse (POP). METHODS: We searched medical databases and organizations websites, to identify national and international guidelines on diagnosis and management of POP. Five authors independently assessed guidelines using the validated AGREE II tool. Its six domains include (1) scope and purpose, (2) stakeholder involvement, (3) rigor of development, (4) clarity of presentation, (5) applicability, and (6) editorial independence. RESULTS: Eight guidelines met the inclusion criteria. Three hundred and thirteen different recommendations were identified. One hundred and ninety-nine recommendations were comparable across guidelines. Thirty-one recommendations were not supported by research evidence. Assessment by history and physical examination using the POP quantification system and consideration of imaging were recommendations featuring in all guidelines. Conservative treatment recommendations namely pelvic floor muscle training and vaginal pessaries were also found in all guidelines. Regarding surgical management, patient counseling, treating only symptomatic POP, consideration of apical fixation during surgical treatment, and use of biological or synthetic implants in recurrent cases were recommendations in all guidelines. Overall, the highest median scores were in the domains "scope and purpose" and "rigor of development". The lowest median score was for applicability (28.3%). Although the median score of "editorial independence" was high (85.4%), variability was also substantial (interquartile range: 12.5-100). CONCLUSION: We identified variations in quality and deficiencies in certain areas, especially "applicability" and "editorial independence." Improvements in these key domains may enhance the quality and clinical impact of clinical practice guidelines.

Impact of COVID-19 on management of urogynaecology patients: a rapid review of the literature.

INTRODUCTION AND HYPOTHESIS: The coronavirus (COVID-19) pandemic has impacted health systems worldwide. There is a continuing need for clinicians to adapt practice to facilitate timely provision of medical care, whilst minimising horizontal transmission. Guidance and recommendations are increasingly available, and this rapid review aimed to provide a timely evidence synthesis on the current recommendations surrounding urogynaecological care. METHODS: We performed a literature review using PubMed/Medline, Embase and Cochrane and a manual search of national and international societies for management recommendations for urogynaecological patients during the COVID-19 pandemic. RESULTS: Nine guidance documents and 17 articles, including 10 reviews, were included. Virtual clinics are recommended for new and follow-up patients, to assess and initiate treatment, as well as triage patients who require face-to-face appointments. Outpatient investigations such as urodynamics and cystoscopy for benign indications can be deferred. Prolapse and continence surgery should be suspended, except in specific circumstances such as procidentia with upper tract complications and failed pessaries. There is no evidence to support a particular route of surgery, but recommendations are made to minimise COVID-19 transmission. CONCLUSIONS: Urogynaecological patients face particular challenges owing to inherent vulnerabilities of these populations. Behavioural and medical therapies should be recommended as first line options and initiated via virtual or remote clinics, which are integral to management during the COVID-19 pandemic. Expanding the availability and accessibility of technology will be increasingly required. The majority of outpatient and inpatient procedures can be deferred, but the longer-term effects of such practices are unclear.

A meta-synthesis of qualitative literature on female chronic pelvic pain for the development of a core outcome set: a systematic review.

INTRODUCTION AND HYPOTHESIS: Qualitative research has an increasing role in the development of core outcome sets (COS) adding patient perspectives to the considerations of core outcomes. We aimed to identify priorities of women with experience of chronic pelvic pain (CPP). METHODS: The search strategy was a systematic review of qualitative studies identified from Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, MEDLINE and PsycInfo databases. Selection criteria were qualitative studies exploring the experience of women with CPP. Two independent researchers extracted data and summarized findings using thematic analysis. A CERQual assessment was performed to assess the confidence of review findings. RESULTS: We identified pertinent issues affecting women with CPP including the lack of holistic care, influence of psychosocial factors and the impact of pain on quality of life. Five meta-themes central to delivering a patient-centred approach were highlighted: acceptance of pain, quality of life, management of CPP, communication and support. Management of CPP was the most commonly reported meta-theme across seven studies and half of studies reported quality of life, management, communication and support. Quality appraisal of included studies identified only a single study that met all CASP (Critical Appraisal Skills Programme) criteria. There was high confidence in the evidence for acceptance of pain, quality of life and communication meta-themes. CONCLUSION: Meta-themes revealed by this review should be considered as a priority and reflected in outcomes reported by future studies evaluating interventions for CPP. In addition, these themes should be considered by clinicians managing women with CPP.

Evaluation of clinical practice guidelines (CPG) on the management of female chronic pelvic pain (CPP) using the AGREE II instrument.

INTRODUCTION AND HYPOTHESIS: Variations in guidelines may result in differences in treatments and potentially poorer health-related outcomes. We aimed to systematically review and evaluate the quality of national and international guidelines and create an inventory of CPG recommendations on CPP. METHODS: We searched EMBASE and MEDLINE databases from inception till August 2020 as well as websites of professional organizations and societies. We selected national and international CPGs reporting on the diagnosis and management of female CPP. We included six CPGs. Five researchers independently assessed the quality of included guidelines using the AGREE II tool and extracted recommendations. RESULTS: Two hundred thirty-two recommendations were recorded and grouped into six categories: diagnosis, medical treatment, surgical management, behavioural interventions, complementary/alternative therapies and education/research. Thirty-nine (17.11%) recommendations were comparable including: a comprehensive pain history, a multi-disciplinary approach, attributing muscular dysfunction as a cause of CPP and an assessment of quality of life. Two guidelines acknowledged sexual dysfunction associated with CPP and recommended treatment with pelvic floor exercises and behavioural interventions. All guidelines recommended surgical management; however, there was no consensus regarding adhesiolysis, bilateral salpingo-oophorectomy during hysterectomy, neurectomy and laparoscopic uterosacral nerve ablation. Half of recommendations (106, 46.49%) were unreferenced or made in absence of good-quality evidence or supported by expert opinion. Based on the AGREE II assessment, two guidelines were graded as high quality and recommended without modifications (EAU and RCOG). Guidelines performed poorly in the "Applicability", "Editorial Independence" and "Stakeholder Involvement" domains. CONCLUSION: Majority of guidelines were of moderate quality with significant variation in recommendations and quality of guideline development.

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review.

INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

An arm-based network meta-analysis on treatments for vulvar lichen sclerosus and a call for development of core outcome sets.

OBJECTIVE: The purpose of the present systematic review is to evaluate the available medical treatments for vulvar lichen sclerosus, using an arm-based network meta-analysis protocol. DATA SOURCES: We searched Medline (1966-2019), Scopus (2004-2019), Cochrane Central Register of Controlled Trials CENTRAL (1999-2019), Clinicaltrials.gov (2008-2019) databases, and Google Scholar (2004-2019) database along with the reference list of all included studies. STUDY ELIGIBILITY CRITERIA: All observational, randomized, and single-arm studies that evaluated medical treatments for vulvar lichen sclerosus were considered eligible for inclusion in the present systematic review. STUDY APPRAISAL: A network meta-analysis was carried out in R 3.4.3 using the pcnetmeta package, which uses a Bayesian hierarchical model (based in Markov chain Monte Carlo convergence simulation). RESULTS: Sixteen studies were included in this present meta-analysis, which recruited 954 women with vulvar lichen sclerosus. Their quality was evaluated with the JADAD, Cochrane risk of bias, and risk of bias in nonrandomised studies of interventions-I tools. Clobetasol treatment ranked as the best treatment for disease remission after evaluating rank probabilities (40% chance of ranking first compared with tacrolimus [38%]). However, the density plot revealed partial overlapping with tacrolimus. The lowest probability of experiencing a relapse was observed with pimecrolimus (15% [2-48%]); however, the density plot revealed significant overlapping with mometasone furoate, testosterone, and clobetasol. CONCLUSION: Robust evidence concerning the superiority of potent steroids at least over calcineurin inhibitors is still lacking in the field of vulvar lichen sclerosus. On the other hand, the gross heterogeneity in terms of selected population, duration of treatment, administered regimen, outcome reporting, and selection of outcome measures leaves several fields unanswered.

The profile of urinary biomarkers in overactive bladder.

AIMS: In overactive bladder (OAB) research, different biomarkers have been proposed as diagnostic tools and may be used to create individual patient profiles. Assessing the diagnostic performance of biomarkers would better outline their utility. Therefore, our aim was to investigate the diagnostic value of four urinary biomarkers: human brain derived neurotrophic factor (hBDNF), malondialdehyde (MDA), h nerve growth factor (hNGF) and h 8-hydroxydeoxyguanosine in women with OAB. These are neurotrophins/oxidative stress markers that have been linked to lower urinary tract symptoms. METHODS: A total of 105 women were included in the study and distributed in two groups: a group with OAB (n = 53) and a control group (n = 50). The levels of the biomarkers were determined using enzyme-linked immunosorbent assay technique and they were compared between the groups. If the Mann-Whitney test demonstrated a statistically significant difference, receiver operating curves (ROC) analysis was undertaken. RESULTS: When normalized to urinary creatinine, hBDNF, MDA, and hNGF showed significantly increased values in women with OAB as compared to controls, whereas 8-OHdG showed no significant difference. The diagnostic performance of these biomarkers was analyzed based on the area under the ROC curve (AUC). MDA had the highest AUC (0.75), followed by hNGF (0.69) and hBDNF (0.67). CONCLUSIONS: Our findings suggest that MDA, a relatively novel biomarker in OAB research, has a fair performance as a diagnostic tool for OAB. Moreover, urinary neurotrophins (NGF and BDNF) as biomarkers may have a role in the diagnostic pathways of women with OAB symptoms.

A systematic review and meta-synthesis of qualitative studies on pelvic organ prolapse for the development of core outcome sets.

AIMS: In the current climate of evidence-based health care, the aim of this meta-synthesis was to collect and systematically analyse data from primary qualitative studies on pelvic organ prolapse (POP), to identify patient-centered perspectives on the natural course of POP. Information acquired in this study may be useful for ongoing research towards the development of core outcome sets (COS) in pelvic floor disorders. METHODS: A CHORUS Working Group performed a standardized search of three different databases (Medline, Embase, Scopus), from inception to October 2019. We selected qualitative studies on women's perspectives on POP that were published in the English language. Three reviewers independently evaluated the quality of eligible papers and highlighted recurrent themes based on patient perspectives. RESULTS: Eighteen qualitative studies including a total of 497 patients were assessed in this analysis. Our study revealed five superordinate themes, recurrently encountered in qualitative studies on POP: awareness of POP (6 studies), communication (9 studies), treatments (10 studies), effects on quality of life (6 studies), and self-image (3 studies). Five out of 10 quality criteria were met by all the studies included, based on an assessment performed using the critical appraisal skills program. CONCLUSIONS: This is the first synthesis of qualitative studies that address POP-related experiences of women, highlighting five superordinate themes, of which treatment was the most commonly reported one. This synthesis' findings may guide quantitative research priorities and will hopefully contribute to the development of a COS for POP.

A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5-year follow-up study.

INTRODUCTION: The aim of this study was to compare long-term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh. METHODS: This multicenter, randomized trial included-at the end of 5 years follow-up-122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse-quantification (POP-Q) point was ≤0. Quality of life was assessed using the prolapse quality-of-life questionnaire and sexual function with the quality of sexual function. RESULTS: Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh (P = .019). Cure rate was significantly better for mesh group in the anterior compartment (P = .002) and in the combination of all compartments (P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment (P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group (P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence (P = .031). CONCLUSIONS: Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5-year follow-up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.

A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research.

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.