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.

Influence of previous delivery mode on perineal trauma risk.

OBJECTIVE: To evaluate the impact of a previous pregnancy and delivery on perineal trauma rates in the subsequent vaginal birth. METHODS: Retrospective cohort study. The perineal outcomes of secundiparous women with history of previous (first) delivery in one of three categories: failed operative vaginal delivery (FOVD) and second-stage emergency cesarean section (EmCS); elective cesarean section (ElCS), and vaginal delivery (VD) with intact perineum, were compared with a control primiparous group. RESULTS: The percentage obstetric anal sphincter injuries (OASIS)at first vaginal delivery was 17.3% (n = 9) after previous FOVD+EmCS, 12.9% (n = 18) after previous ElCS, and 0.6% (n = 9) after previous VD maintaining an intact perineum, compared with 6% (n = 1193) in the control primiparous group of women. Multivariate regression analysis demonstrated that previous FOVD+EmCS and ElCS were associated with a statistically significant increased risk of OASIS of 180% and 110% when compared with control (odds ratio [OR] 2.80; 95% confidence interval [CI] 1.35-5.78 and OR 2.10; 95% CI 1.27-3.48, respectively). Previous VD with intact perineum was associated with a statistically significantly reduced risk of OASIS (OR 0.09; 95% CI 0.04-0.17). CONCLUSIONS: Previous FOVD+EmCS and ElCS were associated with increased risk of OASIS in subsequent vaginal delivery compared with control, whereas previous VD with intact perineum was associated with decreased risk.

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.

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.

A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set.

BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO: CRD42017062456.

Perioperative changes in superficial pelvic organ prolapse quantification system measurements after prolapse surgery.

OBJECTIVES: To evaluate the values of perineal body (PB) and genital hiatus (GH) before and after posterior repair. We also evaluated the introital surface area (ISA)-a sum of transverse and longitudinal GH measurements. METHODS: This secondary analysis of a prospective case series included 94 women undergoing posterior vaginal prolapse surgery at a consultant urogynecology clinic between October 3, 2011, and October 2, 2014. Patients were examined in clinic using the pelvic organ prolapse quantification system with Valsalva maneuver, and in theatre pre- and postoperatively with traction. RESULTS: Immediately postoperatively, a statistically significant change (all P<0.001) was noted for GH (mean difference -0.59 cm), PB (-0.56 cm), and ISA (-0.87 cm) compared with preoperative measurement. This effect was maintained for GH (-0.42 cm) and PB (-0.40 cm) at 2 months' follow-up (both P<0.001), and for PB alone (-0.43 cm; P=0.04) at 8 months. ISA had a moderate correlation with GH (r=0.55). CONCLUSIONS: Posterior repair significantly improved PB length at months 2 and 8, and GH length at month 2. ISA did not correlate with prolapse stage. Changes in GH were not maintained beyond postoperative month 2.

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery.

BACKGROUND: Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data. OBJECTIVE: To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions. SEARCH STRATEGY: We searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language articles published from inception to September 30, 2017, using the terms "management", "repair", "operation", and "pelvic organ prolapse". SELECTION CRITERIA: RCTs on apical prolapse surgical treatment. DATA COLLECTION AND ANALYSIS: Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies. MAIN RESULTS: Forty-three RCTs were included. Seventy-six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome. CONCLUSIONS: Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high-quality meta-analyses to be performed in the future. PROSPERO registration: CRD42017062456.

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research.

The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set.

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (ß = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (ß = 0.078; P = 0.306), year of publication (ß = 0.149; P = 0.295), study size (ß = 0.008; P = 0.961) and commercial funding (ß = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.

A comparative study of obstetric anal sphincter injuries in vaginal deliveries of twins and singleton pregnancies.

AIMS: Increasing numbers of twin pregnancies necessitate investigation of the risk factors associated with obstetric anal sphincter injuries (OASIS). The aims of this study were to establish the incidence of OASIS, and compare women delivering twins to those delivering singletons in risk of OASIS plus maternal, neonatal, and obstetric outcomes. METHODS: A retrospective cohort study was undertaken and included women delivering in a tertiary London maternity unit between 1999 and 2015; 51 957 eligible women with singleton and 261 with twin pregnancies were identified. Women delivering twins were compared to those delivering singletons in the occurrence of maternal, neonatal, and obstetric outcomes using unadjusted relative risks. A secondary analysis was performed, and conditional logistic regression used to derive an adjusted relative risk of OASIS. Women delivering singletons were matched to those delivering twins for age, parity, ethnicity, gestation, and mode of delivery in a ratio of 2:1. RESULTS: Compared to the singleton group, mothers delivering twins had significantly more instrumental deliveries (RR [95%CI] 1.92 [1.67-2.27]; P < 0.0001), smaller fetuses (2754.1 vs 3383.8 g; P < 0.001), and were older (32.9 vs 31.0 years; P < 0.0001). The twin group was not significantly different to the singleton group in risk of OASIS (RR 0.61 [0.27-1.33], P = 0.205). The conditional logistic regression demonstrated similar results for the risk of OASIS (adjusted RR = 0.58 [0.22-1.47]; P = 0.253). CONCLUSIONS: Women delivering twins vaginally were not at a significantly higher risk of sustaining OASIS compared to those delivering singletons.

Effect of body mass index on the incidence of perineal trauma.

OBJECTIVE: To investigate the association between perineal trauma at childbirth and maternal body mass index (BMI), and estimate the risk of perineal trauma among different BMI groups. METHODS: Data were retrospectively assessed from all vaginal deliveries in a UK tertiary maternity unit between 1999 and 2014. Associations between BMI at booking and first- and second-degree tears (minor perineal trauma), third- and fourth-degree tears (obstetric anal sphincter injuries [OASIS]), and frequency of instrumental deliveries were assessed. Multivariate logistic regression included the factors BMI (weight in kilograms divided by the square of height in meters), age, ethnicity, smoking, parity, pregnancy length, episiotomies, instrumental delivery, and birth weight. RESULTS: Data from 45 557 deliveries were used. Compared with women with a normal BMI (<25), odds of minor perineal trauma were significantly reduced among women with obesity (BMI 30 to <35; odds ratio [OR] 0.91, 95% confidence interval [CI] 0.84-0.99) or severe obesity (BMI ≥35; OR 0.87, 95% CI 0.77-0.98). OASIS was not significantly associated with BMI. Instrumental delivery rates were higher among women with normal BMI (5936/27 107; 22.0%) than among those with severe obesity (284/2032; 14.0%). CONCLUSION: Increased BMI at booking was associated with a reduced incidence of minor perineal trauma at delivery, but was not associated with OASIS.

Comparison between the Valsalva maneuver and intraoperative traction measurements in pelvic organ prolapse assessment.

OBJECTIVE: To compare the assessment of pelvic organ prolapse (POP) between the Pelvic Organ Prolapse Quantification (POP-Q) system with Valsalva maneuver and intraoperative measurement with mechanical traction. METHODS: A prospective observational study included 100 women with POP attending a tertiary urogynecology clinic in the UK and undergoing vaginal prolapse surgical procedures between October 2011 and October 2014. The women were examined in the clinic using POP-Q with the Valsalva maneuver and in the operating theater under general anesthesia with mechanical traction. The two sets of measurements were compared. RESULTS: All POP-Q measurements obtained with traction demonstrated significantly higher descent as compared with those measured by Valsalva maneuver (mean differences: Aa 0.64 cm; Ap 1.32 cm; Ba 0.96 cm; Bp 1.34 cm; C 3.57 cm; D 3.40 cm; all P<0.001). The perineal body and total vaginal lengths did not differ significantly. CONCLUSION: Measurements of six POP-Q points obtained with traction showed a higher grade of POP than those assessed with Valsalva maneuver. On this basis, surgeons might decide on the extent of surgical procedure after examination under anesthesia; however, preoperative patient counselling would be essential to obtain consent for this approach. The clinical significance of the findings requires further evaluation.

What is to blame for postnatal pelvic floor dysfunction in primiparous women-Pre-pregnancy or intrapartum risk factors?

BACKGROUND: The aetiology of pelvic floor dysfunction (PFD) is still poorly understood. However childbearing is recognized as a major risk factor. OBJECTIVES: To elucidate the natural history of PFD by investigating the impact of the mode of delivery on postnatal pelvic floor dysfunction in primiparas, when PFD existing before the first pregnancy is taken into consideration. STUDY DESIGN: 4P-study (Prevalence and Predictors of Pelvic floor dysfunction in Primips) is a prospective cohort study, nested within the Screening for Pregnancy Endpoints (SCOPE) study set in a tertiary referral teaching hospital with 9000 deliveries annually. Established and proposed risk factors for urinary, fecal, prolapse and sexual dysfunction and the severity of symptoms for each of these outcomes were assessed using the Australian Pelvic Floor Questionnaire in 1482 nulliparous women, who each completed the questionnaire in early pregnancy. Of these, 1060 (72%) repeated the questionnaire 12 months postpartum.Outcomes were analyzed using multivariate ordinal logistic regression. RESULTS: Significant (p<0.05) risk factors for postpartum PFD were pre-pregnancy presence of similar symptoms Odds Ratio (OR) (5.0-30.0), smoking (OR 2.2-4.6), recurrent UTI (OR 2.2-17.3), high hip circumference (OR1.4-1.6), vigorous exercising (OR 3.1-17.9), induction of labor (OR 1.5-2.3), forceps delivery (OR 1.8-8.8), and 3rd degree perineal tear (OR 2.4-2.7). Cesarean section was associated with a lower risk of stress urinary incontinence (OR 0.3-0.5). Other common pre-pregnancy significant (p<0.05) risk factors for various PFD types prior to the first pregnancy were: diagnosed depression - (OR 1.6-2.1), high BMI (OR 3.1), strenuous exercising (OR 1.3-2.2), recurrent UTI (OR 1.5-2.5) and lower educational achievement (OR 1.5-1.6). CONCLUSIONS: Pre-pregnancy PFD was mainly associated with modifiable risk factors such as smoking and exercising. The main risk factor for postpartum PFD was the presence of similar symptoms prior to pregnancy, followed by anthropometric and intrapartum factors. Hip circumference seems to be a better predictor of PFD compared to BMI. When pre-pregnancy PFD was included in the analysis, Cesarean section was protective only for stress urinary incontinence, while delivery by forceps increased the risk of prolapse.

Three-dimensional volume rendering of pelvic models and paraurethral masses based on MRI cross-sectional images.

AIMS: Our aim was to assess the feasibility of rendering 3D pelvic models using magnetic resonance imaging (MRI) scans of patients with vaginal, urethral and paraurethral lesions and obtain additional information previously unavailable through 2D imaging modalities. METHODS: A purposive sample of five female patients 26-40 years old undergoing investigations for vaginal or paraurethral mass was obtained in a tertiary teaching hospital. 3D volume renderings of the bladder, urethra and paraurethral masses were constructed using 3D-Slicer v.3.4.0. Spatial dimensions were determined and compared with findings from clinical, MRI, surgical and histopathological reports. The quality of information regarding size and location of paraurethral masses obtained from 3D models was compared with information from cross-sectional MRI and review of clinical, surgical and histopathological findings. RESULTS: The analysis of rendered 3D models yielded detailed anatomical dimensions and provided information that was in agreement and in higher detail than information based on clinical examination, cross-sectional 2D MRI analysis and histopathological reports. High-quality pelvic 3D models were rendered with the characteristics and resolution to allow identification and detailed viewing of the spatial relationship between anatomical structures. CONCLUSIONS: To our knowledge, this is the first preliminary study to evaluate the role of MRI-based 3D pelvic models for investigating paraurethral masses. This is a feasible technique and may prove a useful addition to conventional 2D MRI. Further prospective studies are required to evaluate this modality for investigating such lesions and planning appropriate management.