Objective To study which variables are able to influence women's experience of pain during diagnostic hysteroscopy. Design Multivariate analysis (phase II) after a randomized, controlled trial (phase ...I). Setting Endoscopic gynecologic center. Patient(s) In phase I, 392 patients were analyzed. Group A: 197 women with carbon dioxide (CO2 ); group B: 195 women with normal saline. In phase II, 392 patients were assigned to two different groups according to their pain experience as measured by a visual analogue scale (VAS): group VAS >3 (170 patients); group VAS ≤3 (222 patients). Intervention(s) Free-anesthesia diagnostic hysteroscopy performed using CO2 or normal saline as distension media. Main Outcome Measure(s) Procedure time, VAS score, image quality, and side effects during and after diagnostic hysteroscopy. Result(s) In phase I the median pain score in group A was 2, whereas in group B it was 3. In phase II the duration of the procedure, nulliparity, and the use of normal saline were significantly correlated with VAS >3. A higher presence of cervical synechiae was observed in the group VAS >3. The multivariate analysis revealed an inverse correlation between parity and a VAS >3, whereas the use of normal saline, the presence of synechiae in the cervical canal, and the duration of the hysteroscopy were all directly correlated to a VAS score >3. Conclusion(s) Pain in hysteroscopy is significantly related to the presence of cervical synechiae, to the duration of the procedure, and to the use of normal saline; conversely, parity seems to have a protective role. Clinical Trial Registration Number NCT01873391.
To compare robot assisted to laparoscopic sacrocolpopexy, in terms of efficacy, in the treatment of high-stage pelvic organ prolapse.
This was a noninferiority prospective randomized trial conducted ...in a tertiary Urology unit, comparing robot assisted and laparoscopic sacrocolpopexy in patients with symptomatic prolapse stage III and IV, according to the Pelvic Organ Prolapse quantification. All participants provided written informed consent at enrolment. The primary outcome was prolapse objective cure rate. Secondary outcomes included prevalence of urinary, anorectal and sexual symptoms, UDI-6, IIQ7 and FSFI scores, and maximum flow rate. Operative times, intraoperative blood loss, length of hospital stay, postsurgery pain, patient satisfaction as well as surgical and mesh complications were assessed. The Mann-Whitney and Wilcoxon tests for unpaired and paired data, respectively, were used to compare ordinal and nonnormally distributed continuous variables. Categorical data were analyzed by the McNemar, chi-square or Fisher exact test. Two-tailed P <.05 was considered significant.
One hundred patients were randomized. At a mean follow-up of 24.06 months the cure rate for the apical compartment was 100% with both approaches. There were no significant between-group differences in any of the secondary outcomes with the only exception of C/D point values, where results were significantly better in the robot-assisted group. Overall surgical procedure time was longer in the robot-assisted group. The main limitation of our study is the single-centre design and the inclusion of docking time in robotic-procedure surgical time calculations.
Robot-assisted sacrocolpopexy provides outcomes comparable to those of laparoscopic with 100% anatomic correction of the apical compartment.
We aimed to test the diagnostic accuracy in predicting continuous positive airway pressure (CPAP) failure in premature infants with respiratory distress syndrome (RDS) by integrating oxygen ...saturation (SpO
2
)/fraction of inspired oxygen (FiO
2
) (SF ratio) with the measurement of peak velocity of the right diaphragmatic excursions (RD-PV), during the inspiration (I-Peak) and expiratory (E-Peak) phases, performed by pulsed-wave Tissue Doppler imaging. This is a prospective, observational pilot study conducted over a 2-year period. Neonates at ≤ 32 weeks gestation supported by early CPAP were eligible. Natural surfactant was delivered via a minimally invasive technique. We performed serial measurements of SF ratio and RD-PV during the early post-natal hours to test the accuracy in predicting surfactant administration as well as invasive ventilation support within 72 h from birth because of the RDS worsening. Of 56 preterm infants enrolled, 34 (61%) failed CPAP support. SF ratio showed a significant inverse relationship with both Silverman-Andersen score at birth (rho = − 0.417;
P
= .001) and RD-PV E-Peak (rho = − 0.361;
P
= .007). We achieved a high accuracy in predicting CPAP failure (AUC = 95%; 95% CI, 89–100%) by integrating gender, SF ratio, and RD-PV E-Peak at the restricted, multivariate analysis.
Conclusions
: SF ratio and RD-PV, as measured by pulsed-wave Tissue Doppler, may help physicians to improve their confidence in optimizing therapeutic options in preterm infants with RDS.
What is Known:
• Continuous positive airway pressure is the recommended first-line treatment for respiratory distress syndrome in preterm infants, but failure rates remain unacceptably high.
• Choosing the optimal treatment in terms of non-invasive ventilation effectiveness and timeliness of surfactant administration for these patients is often challenging, also due to our inability to identify a worsening respiratory failure.
What is New:
• The integration of oxygen saturation, as measured by SpO
2
/FiO
2
, with right diaphragm peak motion velocities, as measured by pulsed-wave tissue Doppler, allows for high prediction accuracy of non-invasive ventilation support failure in premature infants at risk of respiratory distress syndrome.
• These measurements may help physicians in providing optimal supportive therapy for these patients.
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•PBI is valid alternative to WBI in patients at low-risk of local relapse.•PBI is delivered by means of various techniques, one of which is IOeRT.•After IOeRT, an unexpectedly high LR ...rate was observed in the only phase III RCT.•Patient selection impacts on LR rates after IOeRT.•With appropriate patient selection IOeRT outcomes overlap with other RT techniques.
Botulinum neurotoxin A (BoNT/A) appears to be one of the best intravesical treatments for interstitial cystitis/bladder painful syndrome (IC/BPS). We aimed to point out what the evidence is regarding ...the effects of BoNT/A intravesically injected in patients with IC/BPS. We performed a systematic review of all randomized controlled trials (RCTs) assessing BoNT/A for IC/BPS by using Medline, EMBASE, CINAHL, CENTRAL and MetaRegister of Controlled Trials. Standardized mean differences (SMD) were extracted from the available trials and combined in a meta-analysis applying a random effect model, including heterogeneity of effects. Twelve trials were identified. Significant benefits from BoNT/A injections were detected in: Interstitial Cystitis Symptom Index and Problem Index (ICSI, ICPI) (small to medium effect size: SMD = -0.302;
= 0.007 and -0.430,
= 0.004, respectively); Visual Analog Scale (VAS) for pain and day-time urinary frequency (medium effect size: SMD = -0.576,
< 0.0001 and -0.546,
= 0.013, respectively). A great effect size was detected for post-void residual volume (PVR, SMD = 0.728;
=0.002) although no clinically relevant in most cases. Great heterogeneity was observed in treatments' methodologies and symptoms assessment. Overall, BoNT/A intravesical injections significantly improve some of the most relevant symptoms affecting IC/BPS patients.
Abstract Background Strategies to reduce prostate-specific antigen (PSA)–driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary. Objective To test the accuracy of serum ...isoform −2proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)—called index tests —in discriminating between patients with and without PCa. Design, setting, and participants This was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2–10 ng/ml who were subjected to initial prostate biopsy for suspected PCa. Outcome measurements and statistical analysis The primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis. Results and limitations Of >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p = 0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p < 0.001), %fPSA (0.14 vs 0.17; p < 0.001), %p2PSA (2.1 vs 1.6; p < 0.001), and PHI (48.2 vs 38; p < 0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p < 0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values. Conclusions In patients with a tPSA range of 2–10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA. Trial registration The study is registered at http://www.controlled-trials.com , ref. ISRCTN04707454.
Purpose
Concerns remain on different alveolar deposition of surfactant between LISA and INSURE methods. Ultrasound evaluation of diaphragm kinetics may provide clinical evidence on this issue, as ...indirect representation of the respiratory system compliance.
Methods
This was a prospective-observational pilot study. The inclusion criterion was CPAP-supported infants ≤ 32 weeks with RDS receiving surfactant via minimally invasive technique. 52 patients randomized for surfactant administration via LISA or INSURE methods were enrolled. Right diaphragm (RD) global mean peak velocity (MPV) by Pulsed-Wave Tissue Doppler Imaging (PTDI) was recorded before and two hours after surfactant administration with simultaneous measurements of oxygen saturation (SpO
2
)/fraction of inspired oxygen (FiO
2
) (SF ratio). Mechanical ventilation ≤ 72 h from birth represented treatment failure.
Results
LISA infants had significantly higher gestational age (
p
= 0.029) and birth weight (
p
= 0.030) with lower CRIB-II scores (
p
= 0.030) than INSURE infants. LISA infants showed higher median MPV at baseline RD-PTDI US assessment (
p
= 0.024), but post-surfactant median MPV and other the investigated variables were similar at the adjusted analysis for gestational age and sedation. 8/52 (15%) infants who failed treatment had a significantly lower SF ratio (
p
= 0.002) and higher median MPV at RD-PTDI US (
p
= 0.004) after surfactant administration, despite the higher CPAP support level before (
p
= 0.007) and after (
p
= 0.001) surfactant administration. A full course of antenatal steroids was protective against mechanical ventilation (
p
= 0.038).
Conclusions
Different minimally invasive surfactant administration techniques do not appear to influence diaphragm kinetics evaluated by RD-PTDI US.
The study of the effects of a water-based exercise program in overweight/obese people with or without type 2 diabetes is a topic of relatively recent interest. This type of exercise presents some ...advantages in reducing the risk of injury or trauma, and it can be a valuable therapeutic card to play for sedentary or physically inactive patients who have chronic metabolic diseases. This work aims to make a contribution showing the effects of a water-based exercise intervention, supervised by graduates in sports sciences, in a group of overweight/obese people with or without type 2 diabetes. In total, 93 adults (age 60.59 ± 10.44 years), including 72 women (age 60.19 ± 10.97 years) and 21 men (age 61.95 ± 8.48 years), were recruited to follow a water-based exercise program (2 sessions/week, for 12 weeks) at the C.U.R.I.A.Mo. Healthy Lifestyle Institute of Perugia University. Results showed an improvement in body mass index (−0.90 ± 1.56, p = 0.001), waist circumference (−4.32 ± 6.03, p < 0.001), and systolic (−7.78 ± 13.37, p = 0.001) and diastolic (−6.30 ± 10.91, p = 0.001) blood pressure. The supervised water-based intervention was useful in managing patients with metabolic diseases who often present with other health impairments, such as musculoskeletal problems or cardiovascular or rheumatic disease that could contraindicate gym-based exercise.
Retained placenta represents a cause of maternal morbidity and mortality affecting 0.5-3% of all vaginal deliveries. The unpredictability of this condition makes difficult to develop predictive and ...preventive strategies to apply in clinical practice. This analysis collected and analyzed all known risk factors related to this obstetric complication.
A systematic literature review for all original research articles published between 1990 and 2020 was performed. Observational studies about retained placenta risk factors published in English language were considered eligible. Conference abstracts, untraceable articles and studies focused on morbidly adherent placenta were excluded. The included articles were screened to identify study design, number of enrolled patients and retained placenta risk factors investigated. All stages of the revision followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement.
Thirty-five studies met the inclusion criteria. The reported retained placenta prevalence ranged from 0.5 to 4.8%. Maternal age, previous cesarean sections, previous dilation and curettage, previous retained placenta, labor induction, resulted as the most recurrent, independent risk factors for retained placenta. Previous estro-progestins therapy, morphological placental features (weight, shape, insertion of umbilical cord, implantation site), endometriosis, Assisted Reproductive Technologies, Apgar score are fascinating new proposal risk factors.
Old and new data are not enough robust to draw firm conclusions. Prospective and well-designed studies, based on a well agreed internationally retained placenta definition, are needed in order to clarify this potential dramatic and life-threatening condition.
Purpose We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and Methods We evaluated PHI and PCA3 performance in 211 patients undergoing initial (116) or ...repeat (95) prostate biopsy. Multivariable logistic regression analysis was done using the AUC to test the accuracy of PHI and PCA3 for predicting prostate cancer in the overall population and in each setting. Decision curve analysis was used to compare the clinical benefit of different models. Results Overall, the AUC of the PHI (0.70) was significantly higher than the AUC of PCA3 (0.59), total prostate specific antigen (0.56) and free-to-total prostate specific antigen (0.60) (p = 0.043, 0.002 and 0.037, respectively). PHI was more accurate than PCA3 for predicting prostate cancer in the initial setting (AUC 0.69 vs 0.57) and in the repeat setting (AUC 0.72 vs 0.63), although no statistically significant difference was observed. Including PCA3 in the base multivariable model (prostate specific antigen plus free-to-total prostate specific antigen plus prostate volume) did not increase predictive accuracy in either setting (AUC 0.79 vs 0.80 and 0.75 vs 0.76, respectively). Conversely, including PHI in the base multivariable model improved predictive accuracy by 5% (AUC 0.79 to 0.84) and 6% (AUC 0.75 to 0.81) in the initial and repeat prostate biopsy settings, respectively. On decision curve analysis the highest net benefit was observed when PHI was added to the base multivariable model. Conclusions PHI and PCA3 provide a significant increase in sensitivity and specificity compared to all other examined markers and they may help guide biopsy decisions. PCA3 does not increase the accuracy of predicting prostate cancer when PHI is assessed.
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