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Objective: To evaluate the feasibility and clinical application of fusion imaging with virtual navigation, combining 18F‐fluorodeoxyglucose (18F‐FDG) positron emission tomography/computed tomography (PET/CT) with real‐time ultrasound imaging, in assessing superficial lymph nodes in breast‐cancer and gynecological‐cancer patients. Methods: This was a pilot study of breast‐ and gynecological‐cancer patients with abnormal uptake of 18F‐FDG by axillary or groin lymph nodes on PET/CT scan, examined at our institution between January 2017 and May 2019. Fusion imaging was performed, uploading preacquired PET/CT DICOM images onto the ultrasound machine and synchronizing them with real‐time ultrasound scanning performed at the lymph‐node site. In the first phase, we assessed the feasibility and reliability of fusion imaging in a series of 10 patients with suspicious lymph nodes on both PET/CT and ultrasound, and with full correspondence between both techniques in terms of size, shape and morphology of the lymph nodes (Group A). In the second phase, we included 20 patients with non‐corresponding findings between PET/CT and ultrasound: 10 patients with lymph nodes that were suspicious or pathological on PET/CT scan but not suspicious on ultrasound assessment (Group B), and 10 patients with suspicious or pathological lymph nodes on both PET/CT and ultrasound but with no correspondence between the two techniques in terms of number of affected lymph nodes (Group C). Results: In the 30 selected patients, fusion imaging was assessed at 30 lymph‐node sites (22 inguinal and eight axillary nodes). In the first phase (Group A), the fusion technique was shown to be feasible in all 10 lymph‐node sites evaluated. In the second phase, fusion imaging was completed successfully in nine of 10 cases in Group B and in all 10 cases in Group C. In all groups, fusion imaging was able to identify the target lymph node, guiding the examiner to perform a core‐needle aspiration biopsy or to inject radiotracer for selective surgical nodal excision, according to the radio‐guided occult lesion localization technique. Conclusion: Fusion imaging with virtual navigation, combining PET/CT and real‐time ultrasound imaging, is technically feasible and able to detect target lymph nodes even when PET/CT and ultrasound findings are inconsistent. Fusion imaging can also be used to guide the performance of core‐needle aspiration biopsy, avoiding further surgical diagnostic procedures, or the injection of radiotracer for selective surgical nodal excision, enabling more sparing, selective surgery. This innovative technique could open up multiple diagnostic and therapeutic opportunities in breast and gynecological oncology. © 2021 International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Objective: To determine the efficacy of ultrasound in assessing the inguinal lymph nodes in patients with vulvar cancer., Methods: A systematic review of published research up to October 2020 that compares the results of ultrasound to determine groin node status with histology was conducted. All study types that reported primary data on the role of ultrasound in the evaluation of groin lymph nodes in vulvar cancer were included in the systematic review. Data retrieved from the included studies were pooled in random-effects meta-analyses., Results: After the screening and selection process, eight articles were deemed pertinent for inclusion in the systematic review and meta-analysis. The random-effects model showed a pooled Se of 0.85 (95% CI: 0.81-0.89), Sp of 0.86 (95% CI: 0.81-0.91), PPV of 0.65 (95% CI: 0.54-0.79) and NPV of 0.92 (95% CI: 0.91-0.94). There was a pooled LR+ and LR- of 6.44 (95% CI: 3.72-11.4) and 0.20 (95% CI: 0.14-0.27), respectively. The pooled accuracy was 0.85 (95% CI: 0.80-0.91)., Conclusions: Although the studies had small sample sizes, this review represents the best summary of the data so far. Ultrasound has revealed high sensitivity and high negative predictive value in the assessment of nodal status in vulvar cancer.

Sentinel node biopsy (SNB) is the standard of care in women with breast cancer (BC) and clinically nonsuspicious axillary lymph nodes (LNs), due to its high negative predictive value (NPV) in the assessment of nodal status. SNB has significantly reduced complications related to the axillary lymph node dissection, such as lymphedema and upper limb dysfunction. The gold standard technique for SNB is the blue dye (BD) and technetium labelled nanocolloid (Tc-99m) double technique. However, nuclear medicine is not available in all Institutions and several new tracers and devices have been proposed, such as indocyanine green (ICG) and superparamagnetic iron oxides (SPIO). All these techniques show an accuracy and detection rate not inferior to that of the standard technique, with different specific pros and cons. The choice of how to perform a SNB primarily depends on the surgeon's confidence with the procedure, the availability of nuclear medicine and the economic resources of the Institutions. In this setting, new tracers, hybrid tracers and imaging techniques are being evaluated in order to improve the detection rate of sentinel lymph nodes (SNs) and minimize the number of unnecessary axillary surgeries through an accurate preoperative assessment of nodal status and to guide new minimally invasive diagnostic procedures of SNs. In particular, the contrast-enhanced ultrasound (CEUS) is an active field of research but cannot be recommended for clinical use at this time. The ICG fluorescence technique was superior in terms of DR, as well as having the lowest FNR. The DR descending order was SPIO, Tc, dual modality (Tc/BD), CEUS and BD. This paper is a narrative review of the most common SNB techniques in BC with a focus on recent innovations.

Childhood interstitial lung disease (chILD) comprises >200 rare respiratory disorders, with no currently approved therapies and variable prognosis. Nintedanib reduces the rate of forced vital capacity (FVC) decline in adults with progressive fibrosing interstitial lung diseases (ILDs). We present the design of a multicentre, prospective, double-blind, randomised, placebo-controlled clinical trial of nintedanib in patients with fibrosing chILD (1199-0337 or InPedILD; ClinicalTrials.gov: NCT04093024). Male or female children and adolescents aged 6-17 years (≥30; including ≥20 adolescents aged 12-17 years) with clinically significant fibrosing ILD will be randomised 2:1 to receive oral nintedanib or placebo on top of standard of care for 24 weeks (double-blind), followed by variable-duration nintedanib (open-label). Nintedanib dosing will be based on body weight-dependent allometric scaling, with single-step dose reductions permitted to manage adverse events. Eligible patients will have evidence of fibrosis on high-resolution computed tomography (within 12 months of their first screening visit), FVC ≥25% predicted, and clinically significant disease (Fan score of ≥3 or evidence of clinical progression over time). Patients with underlying chronic liver disease, significant pulmonary arterial hypertension, cardiovascular disease, or increased bleeding risk are ineligible. The primary endpoints are pharmacokinetics and the proportion of patients with treatment-emergent adverse events at week 24. Secondary endpoints include change in FVC% predicted from baseline, Pediatric Quality of Life Questionnaire, oxygen saturation, and 6-min walk distance at weeks 24 and 52. Additional efficacy and safety endpoints will be collected to explore long-term effects., Competing Interests: Conflict of interest: R. Deterding reports scientific advisory and consulting fees paid to the University of Colorado, and manuscript preparation assistance from Boehringer Ingelheim Pharmaceuticals Inc., during the conduct of the study. Conflict of interest: M. Griese reports personal fees from Boehringer Ingelheim during the conduct of the study and grants from Boehringer Ingelheim outside the submitted work. Conflict of interest: G. Deutsch reports consulting fees paid to Seattle Children's Hospital by Boehringer Ingelheim during the conduct of the study. Conflict of interest: D. Warburton serves in an advisory role for Boehringer Ingelheim on the evaluation of nintedanib as a potential treatment for childhood ILD, and has received reimbursement for travel and consultation in this role. Conflict of interest: E.M. DeBoer reports consulting fees from Boehringer Ingelheim and Parexel, and consulting fees from and stock in EvoEndoscopy, outside the submitted work. Conflict of interest: S. Cunningham reports consultancy fees paid to the University of Edinburgh by Boehringer Ingelheim during the conduct of the study. Conflict of interest: A. Clement has nothing to disclose. Conflict of interest: N. Schwerk reports consulting fees from Boehringer Ingelheim outside the submitted work. Conflict of interest: K.R. Flaherty reports grants and personal fees from Boehringer Ingelheim, and personal fees from Roche/Genentech, Bellerophan, Respivant and Blade Therapeutics, outside the submitted work. Conflict of interest: K.K. Brown reports, outside the submitted work, grants from NHLBI, personal fees from Biogen and advisory board participation for Blade, Boehringer Ingelheim, Galapagos, Galecto, Genoa, Lifemax, MedImmune, OSIC (Open Source Imaging Consortium), Pliant, ProMetic, Third Pole, Theravance, Three Lakes Partners and Veracyte. Conflict of interest: F. Voss is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. Conflict of interest: U. Schmid is an employee of Boehringer Ingelheim. Conflict of interest: R. Schlenker-Herceg is an employee of Boehringer Ingelheim. Conflict of interest: D. Verri is an employee of Boehringer Ingelheim Italia S.p.A. Conflict of interest: M. Dumistracel is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. Conflict of interest: M. Schiwek is an employee of Boehringer Ingelheim Pharma GmbH & Co. KG. Conflict of interest: S. Stowasser is an employee of Boehringer Ingelheim International GmbH. Conflict of interest: K. Tetzlaff is an employee of Boehringer Ingelheim International GmbH. Conflict of interest: E. Clerisme-Beaty is an employee of Boehringer Ingelheim. Conflict of interest: L.R. Young reports personal fees for advisory board participation from Boehringer Ingelheim, and grants from the NIH, during the conduct of the study. All authors disclose third-party writing assistance contracted and funded by Boehringer Ingelheim International GmbH., (Copyright ©The authors 2021.)

Background: There are limited data on ultrasound morphologic features of gestational trophoblastic neoplasia. A predictive model to determine predictors of response to therapy would be ideal in the management of patients with this rare disease., Primary Objectives and Study Hypothesis: TITANIUM is a prospective, multicenter, observational study aiming to describe ultrasound features of gestational trophoblastic neoplasia and to investigate the role of ultrasound in identifying patients at high risk of resistance to single-drug therapy. The study hypothesis is that ultrasound could improve the International Federation of Gynecology and Obstetrics (FIGO) scoring system for early identification of patients predisposed to single-drug resistance., Trial Design and Major Inclusion/exclusion Criteria: Patients eligible have a diagnosis of gestational trophoblastic neoplasia according to FIGO or the criteria set by Charing Cross Hospital, London, UK. At diagnosis, patients are classified as low-risk (score 0-6) or high-risk (score >6) according to the FIGO risk scoring system, and a baseline ultrasound scan is performed. Patients receive treatment according to local protocol at each institution. Follow-up ultrasound examinations are performed at 1, 4, 10, 16, and 22 months after start of chemotherapy, and at each scan, serum human chorionic gonadotropin (hCG) level, and chemotherapy treatment, if any, are recorded., Primary Endpoints: Our aims are to define ultrasound features of gestational trophoblastic neoplasia and to develop a predictive model of resistance to single-drug therapy in low-risk patients., Sample Size: The sample size was calculated assuming that 70% of patients with gestational trophoblastic neoplasia are at low risk, and estimating the rate of resistance to single-drug therapy in this group to be 40%. Assuming a dropout rate of 10%, we should recruit at least 120 patients. With this sample size, we can attempt to create a mathematical model with three variables (either two ultrasound parameters in addition to the risk score or three ultrasound variables statistically significant at univariate analysis) to predict resistance to single-drug therapy in low-risk patients., Estimated Dates for Completing Accrual and Presenting Results: The accrual started in February 2019. Additional referral centers for gestational trophoblastic disease, with similar ultrasound expertise, are welcome to participate in the study. Enrollment should be completed by December 2021, and analysis will be conducted in December 2023., Trial Registration: The study received the Ethical Committee approval of the Coordinator Center (Rome) in January 2019 (Protocol No. 0004668/19)., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The effect of chemotherapy exposure (CE) on ovarian function in young women with ovarian neoplasms undergoing fertility-sparing treatment (FST) remains unclear. We investigated whether CE is correlated with the outcomes (1) during-treatment and (2) post-treatment amenorrhea, (3) conception rate, (4) pregnancy outcome, and (5) spontaneous menopausal age., Patients and Methods: Eligibility criteria were patients with a diagnosis of epithelial (EOC) or nonepithelial (no-EOC) invasive ovarian neoplasm, premenopausal age, undergoing FST ± CE, histopathology confirmation, and adequate follow-up. The groups' outcomes were compared by logistic and linear regression analysis., Results: A total of 548 patients diagnosed during 1980 and 2014 were included, 198 in the EOC group and 350 in the no-EOC group, and 44% received chemotherapy, with a median follow-up of 15.9 years. In no-EOC patients, CE conferred a higher risk for Outcomes 1 (adjusted OR [aOR] 27; 95% CI 12 to 61; P < .0001) and 2 (aOR 5.42; 95% CI 1 to 24; P = .0256) and was associated with a younger menopausal age (adjusted β -5.52; 95% CI -10.53 to -0.52; P = .0313). Overall, 57% of patients attempted pregnancy, with a conception rate of 89%. In EOC patients, no association between CE and a decreased fertility was demonstrated (aOR, 3.05; 95% CI 0.72 to 12.88; P = .1298)., Conclusions: CE in no-EOC was associated with an increased risk of during-treatment amenorrhea, post-treatment amenorrhea, and earlier spontaneous menopausal age; CE in EOC was not associated with any item at study. Patients undergoing FST had reassuringly high conception rates and low premature ovarian failure rates; however, in pretreatment counseling, the risks of this approach in such young population should be discussed., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: Aim of the study is to evaluate the impact of different doses of indocyanine green (ICG) on the sentinel lymph-node (SLN) mapping in endometrial cancer (EC)., Materials and Methods: A retrospective analysis of EC patients undergoing a laparoscopic SLN mapping at two institutions was performed. Two different injection protocols were used (protocol # 1: 5 mg/ml and a volume of 8 ml; protocol # 2: 1.25 mg/ml and a volume of 4 ml). In every case, the injection was intracervical. The laparoscopic equipment adopted was the same among both institutions. Overall and bilateral detection rates (DR) and median number of retrieved SLNs were calculated. At uni- and multivariate analysis factors (including ICG dose) associated with DR and number of detected SLNs were investigated., Results: Overall, 168 patients were included. The overall and bilateral DR were 96.3 and 84.5%. Median number of removed SLNs was 3 (0-18). In 56% of the patients, a median number of 6 (1-93) non-SLNs (NSLNs) were removed. Seventeen (10.1%) patients had metastatic SLNs. At multivariate analysis, no factors were associated with bilateral DR. ICG dose was the only factor associated with number of removed SLNs at multivariate analysis., Conclusion: A larger dose of ICG is associated with a higher number of retrieved SLNs but not with an increased bilateral DR.

Unfortunately, the P value at multivariate analysis for ICG concentration in Table 3 was incorrectly published.

Study Objective: To present our minimally invasive laparoscopic approach for sentinel lymph node (SLN) mapping with indocyanine green (ICG) using 2 fluorescence systems., Design: A step-by-step video description of the technique showing the most frequent typical and atypical location of SLNs (educational video)., Setting: Lymph node staging in apparent confined endometrial cancer., Patients: Women underwent SLN mapping in a minimally invasive setting., Interventions: Laparoscopic SLN mapping before comprehensive staging including simple hysterectomy, bilateral salpingo-oophorectomy, and pelvic and aortic bilateral lymphadenectomy in case of unilateral or no identification of SLNs. The PINPOINT 0 degree HD S1 SPY camera (PINPOINT Endoscopic Fluorescence Imaging System; NOVADAQ, Mississauga, ON, Canada) or the Full HD Image 1S with ICG camera (Karl Storz Endoscopy, Tuttlingen, Germany) were used for SLN detection [1,2]. The ICG powder was diluted to a final solution of 1.25 mg/mL of fluorescent dye. After the induction of general anesthesia, a total of 4 mL of the ICG solution was injected into the cervix at the 3 and 9 o'clock positions. Attention to the technical details is crucial to correctly identify SLNs that sometimes are located in atypical locations [3]., Conclusion: Both fluorescence systems are valid and applicable for SLN mapping in the case of apparent confined endometrial cancer. In our experience, the PINPOINT system seems to allow surgeons easier and faster nodal staging of the SLNs, particularly with the color-segmented fluorescence function activated, which can better discriminate between the lymphatic channels and the real SLNs [4,5]., (Copyright © 2017 American Association of Gynecologic Laparoscopists. Published by Elsevier Inc. All rights reserved.)

Objective: This study aimed to evaluate III and IV degree tears rates and related risk factors in a single Italian centre. The secondary goal was to build a predictive model based on identified risk factors., Study Design: This was a retrospective cohort study. All vaginal deliveries from 2011 to 2015 in a single Italian University Hospital were analysed. Univariate analysis was applied to evaluate the overall association between each factor and severe tear. Multivariate logistic regression was used to build a predictive model for the absolute risk of severe tear. We computed a resampling validated measure (AUC) of the predictive accuracy of the model and we provided a nomogram for the risk calculation in clinical practice., Results: 62 out of 10133 patients (0.61%) had a severe perineal tear. Univariate analysis identified gestational age >40 weeks, nulliparity, moderate/severe obesity, oxytocin use in pushing stage, sinciput presentation, instrumental delivery, shoulder dystocia, pushing stage ≥90 min, lithotomy position, birth weight >4 kg, head circumference at birth >34 cm and length at birth >50 cm as risk factors. Multivariate analysis identify moderate/severe obesity (OR = 2.8), instrumental delivery (OR = 2.6) and birth weight (OR = 1.1/hg) as independent risk factors. Using the predicted risk score from the final model (bootstrap-validated AUC 70%), we designed a nomogram for severe perineal tears absolute risk calculation., Conclusion: Moderate/severe obesity, instrumental delivery and foetal weight resulted as independent risk factors for severe obstetrical tears., (Copyright © 2017 Elsevier B.V. All rights reserved.)

We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12-17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV 1 ) within 3 h post-dosing (FEV 1(0-3h) ) and trough FEV 1 , respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV 1(0-3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV 1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed., Competing Interests: can be found alongside this article at erj.ersjournals.com, (Copyright ©ERS 2017.)

Introduction and Hypothesis: Uterosacral ligament suspension at the time of primary prolapse repair represents a well-established surgical option. Our aim was to compare the effectiveness, complications rate, and functional results of modified McCall culdoplasty and Shull suspension., Methods: Patients who underwent vaginal hysterectomy and cuff suspension for pelvic organ prolapse were retrospectively analyzed. McCall culdoplasty (group A) or Shull suspension (group B) were performed according to surgeon choice based on age and sexual activity. Perioperative data, objective, and subjective cure rate were noted., Results: A total of 339 patients (215 in group A and 124 in group B) completed follow-up. Operating time and blood loss were slightly higher in group B. The complications rate was similar in the two groups. Anatomical outcomes in terms of recurrence and reoperation rate did not show any statistically significant differences. POP-Q items analysis revealed only a different total vaginal length between groups (8 mm longer in group B). Functional outcomes were similar in the two groups as was patient satisfaction., Conclusion: Both uterosacral ligament suspension procedures were shown to be safe and effective. There were no clinically significant differences with regard to surgical data, complications, anatomical, functional, and subjective outcomes between modified McCall culdoplasty and Shull suspension.

Background: The credibility of sentinel lymph node (SLN) mapping is becoming increasingly more established in cervical cancer. We aimed to assess the sensitivity of SLN biopsy in terms of detection rate and bilateral mapping in women with cervical cancer by comparing technetium-99 radiocolloid (Tc-99(m)) and blue dye (BD) versus fluorescence mapping with indocyanine green (ICG)., Methods: Data of patients with cervical cancer stage 1A2 to 1B1 from 5 European institutions were retrospectively reviewed. All centers used a laparoscopic approach with the same intracervical dye injection. Detection rate and bilateral mapping of ICG were compared, respectively, with results obtained by standard Tc-99(m) with BD., Results: Overall, 76 (53 %) of 144 of women underwent preoperative SLN mapping with radiotracer and intraoperative BD, whereas 68 of (47 %) 144 patients underwent mapping using intraoperative ICG. The detection rate of SLN mapping was 96 % and 100 % for Tc-99(m) with BD and ICG, respectively. Bilateral mapping was achieved in 98.5 % for ICG and 76.3 % for Tc-99(m) with BD; this difference was statistically significant (p < 0.0001)., Conclusions: The fluorescence SLN mapping with ICG achieved a significantly higher detection rate and bilateral mapping compared to standard radiocolloid and BD technique in women with early stage cervical cancer. Nodal staging with an intracervical injection of ICG is accurate, safe, and reproducible in patients with cervical cancer. Before replacing lymphadenectomy completely, the additional value of fluorescence SLN mapping on both perioperative morbidity and survival should be explored and confirmed by ongoing controlled trials.

Objective: Pelvic reconstructive surgery can be associated to correction, persistence, or onset of stress urinary incontinence. The aim of our study was to evaluate the incidence of stress incontinence (SI) after prolapse repair in 3 groups with different preoperative urodynamic findings and to find out the predictiveness of occult SI., Methods: Patients undergoing vaginal hysterectomy, uterus-sacral ligament colposuspension, and traditional anterior repair for pelvic prolapse were retrospectively analyzed. No patient underwent any additional anti-incontinence procedure. Preoperative evaluation included clinical history, physical examination, and urodynamic assessment with a pessary reduction test. According to urodynamic findings, women were divided into SI (A), occult SI (B), and continence (C) groups. Primary outcome was to compare the incidence of postoperative SI among groups. Secondary outcome was to assess postoperative quality of life with International Consultation on Incontinence questionnaire-short form questionnaire., Results: One hundred fifty patients were analyzed (A: n = 30; B: n = 43; C: n = 77). Mean follow-up was 18.4 ± 0.9 months without differences among groups. Patients in group B did not have higher postoperative SI rate compared to group C. There were no differences in International Consultation on Incontinence questionnaire-short form scores in symptomatic women among groups., Conclusions: In our series, occult stress urinary incontinence is a poor urodynamic marker to predict the development of postoperative SI.

Sentinel lymph node (SLN) mapping is emerging as an effective method for surgical staging of different gynecologic malignancies. Near-infrared (NIR) technology using a fluorescent dye such as indocyanine green (ICG) represents an interesting and feasible method for SLN mapping even in traditional open surgeries by applying video telescope operating microscope (VITOM) system technology. We report our preliminary experience in 12 women who underwent surgical nodal staging for early-stage vulvar and uterine or cervical cancer. Surgical and pathological outcomes are described, and the VITOM II ICG system's intraoperative image quality, handling and docking, and teaching value are assessed. The general impression of the surgical staff was that the VITOM II system is easy to use, and that the image quality of the anatomic structures is impressive. Traditional open SLN mapping with ICG appears to be easy to perform and reproducible, providing a new tool in the management of patients with gynecologic malignancies. Moreover, we believe that this technology has great potential as an operative teaching and learning modality for trainers for open surgical cases. Additional studies involving the VITOM system with a large sample size of patients are needed to confirm these promising results., (Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: Unsuccessful primary repair of fourth-degree obstetric trauma can lead to permanent communication between the rectum and the vagina, which, in association with full-thickness anal sphincter defects, is characterized by complete fecal incontinence and severe impairment of quality of life. The aim of this video is to serve as a tutorial for repair., Methods: A 27-year-old woman who developed a full-thickness recto-vaginal defect extended from the perineum to the upper third of the vagina has been managed through layered surgical repair without flaps., Results: Anatomy and fecal continence have been completely restored by a follow-up of 24 months., Conclusion: The procedure described in this video has been shown to be effective and safe.

Introduction and Hypothesis: The aim of this study was to evaluate the functional outcome of a single-incision sling procedure for the treatment of female stress urinary incontinence (SUI) and to correlate the cure rate with a pelvic floor ultrasound examination, Methods: Fifty-seven patients treated with a single-incision sling procedure between January 2009 and September 2010 were included in the study. Functional outcome was evaluated as objective cure rate assessed with stress test and subjective cure rate determined by the International Consultation on Incontinence-Short Form and Patient Global Impression of Improvement scores. Women underwent perineal ultrasound examination by a combined 2D translabial and 3D transvaginal approach to assess bladder neck and tape mobility, tape position along the urethral axis, and tape anchorage. According to the position of self-fixating tips, we divided patients into group A (both tips crossed the obturator membrane), group B (only one tip crossed the obturator membrane) and group C (none of the tips crossed the obturator membrane). Objective cure rate and type of anchorage were compared with all ultrasound parameters., Results: At an average follow-up of 13 months objective cure rate was 87.7 % with a significant subjective improvement. A significant difference in tape mobility was noted between group A and group C. Bladder neck mobility significantly increased in failures. Sling was significantly closer to mid-urethra in cured than in failures., Conclusions: In 77 % of patients MA didn't reach the obturator membrane on both sides. This feature conditioned significantly bladder neck mobility but not the efficacy of the procedure. Tape position seems to be the most important factor for success.

Background: Patients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms., Methods: Adults with moderate or severe RLS were randomized to receive placebo or pramipexole (flexibly titrated from 0.25 to 0.75mg), 2-3h before bedtime for 12 weeks. The co-primary outcome measures were change in Medical Outcomes Study (MOS) sleep disturbance score and International RLS Study Group Rating Scale (IRLS) score at 12 weeks., Results: The intent-to-treat population included 357 patients: 178 received pramipexole and 179 received placebo. At 12 weeks, the adjusted mean change from baseline was greater for pramipexole (vs. placebo) for IRLS score (-13.4+/-0.7 vs. -9.6+/-0.7) and MOS sleep disturbance score (-25.3+/-1.5 vs. -16.8+/-1.5) (p