Manuel Di Biase
University of Perugia
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Featured researches published by Manuel Di Biase.
The Journal of Urology | 2016
Elisabetta Costantini; Luigi Mearini; Massimo Lazzeri; Vittorio Bini; Elisabetta Nunzi; Manuel Di Biase; Massimo Porena
PURPOSE Few randomized, controlled trials have compared standard abdominal sacrocolpopexy and the laparoscopic approach. We tested the hypothesis that laparoscopic sacrocolpopexy could compete with abdominal sacrocolpopexy for pelvic organ prolapse repair. MATERIALS AND METHODS This randomized, controlled trial was done to compare laparoscopic sacrocolpopexy and abdominal sacrocolpopexy for pelvic organ prolapse repair in women referred to our tertiary Department of Urology for symptomatic stage 2 or greater pelvic organ prolapse. The primary outcome was quantitative evaluation by the POP-Q (Pelvic Organ Prolapse Quantification) system. Cure was defined as prolapse stage 1 or less, point C/D -5 or less at the apex and at least 7 cm total vaginal length. Secondary outcomes were the complication rate, operative time, intraoperative blood loss, hospital stay and PGI-I (Patient Global Impression of Improvement) scores. The Kaplan-Meier estimator with the log-rank test was used to estimate pelvic organ prolapse recurrence-free survival rates. RESULTS A total of 200 patients were eligible for study. We compared 60 and 61 patients treated with abdominal and laparoscopic sacrocolpopexy, respectively. At a mean followup of 41.7 months the cure rate was of 100% for both approaches. Kaplan-Meier curves showed that overall pelvic organ prolapse recurrence-free survival was longer following the open approach. Patients treated with laparoscopic sacrocolpopexy showed significantly earlier recurrence (p = 0.030), mostly in the first 12 months after surgery. When evaluating the different compartments, a statistically significant difference was observed between the laparoscopic and abdominal approaches for anterior compartment descensus (11 vs 1, p = 0.004). Statistical results had high internal validity but may not be applicable to other populations or settings. CONCLUSIONS Laparoscopic sacrocolpopexy provides outcomes as good as those of abdominal sacrocolpopexy for anatomical correction but not for anterior pelvic organ prolapse.
BMJ Open | 2016
Oriana Ciani; Erik Arendsen; Martin Romancik; Richard Lunik; Elisabetta Costantini; Manuel Di Biase; Giuseppe Morgia; Eugenia Fragalà; Tomaskin Roman; Marian Bernat; Giorgio Guazzoni; Rosanna Tarricone; Massimo Lazzeri
Objectives To compare the clinical effectiveness of the intravesical administration of combined hyaluronic acid and chondroitin sulfate (HA+CS) versus current standard management in adult women with recurrent urinary tract infections (RUTIs). Setting A European Union-based multicentre, retrospective nested case–control study. Participants 276 adult women treated for RUTIs starting from 2009 to 2013. Interventions Patients treated with either intravesical administration of HA+CS or standard of care (antimicrobial/immunoactive prophylaxis/probiotics/cranberry). Primary and secondary outcome measures The primary outcome was occurrence of bacteriologically confirmed recurrence within 12 months. Secondary outcomes were time to recurrence, total number of recurrences, health-related quality of life and healthcare resource consumption. Crude and adjusted results for unbalanced characteristics are presented. Results 181 patients treated with HA+CS and 95 patients treated with standard of care from 7 centres were included. The crude and adjusted ORs (95% CI) for the primary end point were 0.77 (0.46 to 1.28) and 0.51 (0.27 to 0.96), respectively. However, no evidence of improvement in terms of total number of recurrences (incidence rate ratio (95% CI), 0.99 (0.69 to 1.43)) or time to first recurrence was seen (HR (95% CI), 0.99 (0.61 to 1.61)). The benefit of intravesical HA+CS therapy improves when the number of instillations is ≥5. Conclusions Our results show that bladder instillations of combined HA+CS reduce the risk of bacteriologically confirmed recurrences compared with the current standard management of RUTIs. Total incidence rates and hazard rates were instead non-significantly different between the 2 groups after adjusting for unbalanced factors. In contrast to what happens with antibiotic prophylaxis, the effectiveness of the HA+CS reinstatement therapy improves over time. Trial registration number NCT02016118.
European Urology | 2014
Elisabetta Costantini; Massimo Lazzeri; Alessandro Zucchi; Manuel Di Biase; Massimo Porena
Midurethral slings are currently considered the gold standard in the surgical treatment of stress urinary incontinence (SUI). Lack of long-term outcomes is a major debating point in urogynecology, and data on the long-term durability of anti-incontinence procedures are needed because female life expectancy is significantly lengthening in developed countries. Recently, we investigated the extended long-term results of a group of women previously included in a prospective randomized study designed to compare the safety and success rates of tension-free vaginal tape (TVT) and transobturator tape (TOT) in the treatment of female SUI [1,2]. In the current analysis, we collected long-term data of women who were enrolled at the Department of Urology at the University of Perugia. Briefly, the inclusion criteria were SUI or predominantly stress mixed urinary incontinence associated with urethral hypermobility, according to the International Continence Society classification. Exclusion criteria were previous anti-incontinence surgery and pelvic organ prolapse greater than stage I in any vaginal compartment, according to the Pelvic Organ Prolapse Quantification System classification [3]. The preoperative workup included a detailed case history; clinical, neurologic, and urogynecologic examination; compilation of the Urogenital Distress Inventory (UDI-6) and Impact Incontinence Quality of life (IIQ-7) questionnaires; and a Valsalva stress test at physiological maximum bladder capacity and a preoperative urodynamic test including Valsalva leak point pressure evaluation. Standard operative techniques were the TVT according to the Ulmsten technique (Gynecare; Ethicon, Somerville, NJ, USA) and TOT according to the Delorme technique (ObTape; Mentor-Porges, Le Plessis-Robinson, France) [4]. The primary outcome was the assessment of objective and subjective cure rates. The objective cure rate was based on a repeatedly negative provocative stress test with the bladder filled to the capacity, a negative 1-h pad test, and no further treatment for urinary incontinence (behavioral, pharmacologic, or surgical). The subjective criteria were assessed with a 3-d voiding diary, evaluation with
Current Bladder Dysfunction Reports | 2016
Manuel Di Biase; Valerio Iacovelli; Ervin Kocjancic
Purpose of reviewWe aim to summarize and broaden the knowledge regarding diagnosis and treatment options of vulvodynia. This review also aims to describe epidemiology, presumed etiopathology, and the future directions of treating vulvodynia in order to add to understand to whether the disorders should be distinguished or combined.Recent findingsVulvodynia is an extremely common genital pain syndrome. Although common, most practitioners are uncomfortable with the diagnosis and management of these women’s pain.SummaryThis was a review of all relevant studies with no language restrictions. The following databases were widely searched from inception to the end of March 2016 for published and unpublished research evidence: MEDLINE, EMBASE, ISI Web of Science (WoS), including Science Citation Index, and the Conference Proceedings Citation Index-Science; Scopus; The Cochrane Library including the Cochrane Systematic Reviews Database (CDSR), Cochrane Controlled Trials Register (CCRT), and ClinicalTrials.gov database. The most recent uro-gynecological guidelines were searched. Existing reviews were also checked for eligible studies. Full search terms were a combination of the following: (provoked, localized) vulvodynia, vestibulodynia, vulvar vestibulitis syndrome, vulval vestibulitis, clitorodynia, hemivulvodynia, vaginismus, (superficial) dyspareunia, sexual dysfunction, and pain. We searched the medical literature relating to the etiology, diagnosis, and treatment of vulvodynia. Although many treatment options are available, no treatment is effective for all patients, thus the need to individualize management. Further studies are needed to better understand the etiopathogenesis and the optimal treatment.
The Journal of Urology | 2017
Manuel Di Biase; Illiano Ester; Elena Sarti; Alessandro Zucchi; Raffaele Balsamo; Antonio Luigi Pastore; Elisabetta Costantini
RESULTS: Between 2011 and 2016, a total of 175 patients underwent robotic sacrocolpopexy for POP-Q Stage IV VVP. 50 patients undergoing repair with a heavy mesh weight (52 g/m2, 527 microns thick, and a suture pull out strength of 18.3 N) were matched to 50 patients undergoing repair with a lighter weight mesh ( 25 g/m2, 200 microns thick, and suture pull out strength of 23.3 N). At two year followup, anatomic success for apical prolapse was 100% and 2 patients (4%) in each group were found to have residual Grade 2 anterior prolapse and 2 patients (4%) in each group found to have Grade 2 posterior prolapse. De novo SUI was found in 5 patients (10%) in the heavy mesh group and 4 patients (8%) in the lighter mesh group. All de novo SUI patients did not have a mid urethral sling, MUS, placed at the time of the procedure. There was one mesh erosion in the light weight mesh group in a salvage patient that underwent concomitant pre-existing mesh removal at the time of surgery. CONCLUSIONS: Although the two Y-meshes are markedly different in their weight, surface area, thickness and suture pullout strength, there was no observed significant difference in the anatomic success of repair, the rate of de novo stress urinary incontinence or mesh erosion. The rates of de novo SUI seen in this study, have led us to perform a MUS procedure at the time of sacrocolpopexy for all Grade IV prolapse patients.
The Journal of Urology | 2017
Ester Illiano; Manuel Di Biase; Pasquale Di Tonno; Gaetano De Rienzo; Alessandro Zucchi; Luigi Mearini; Daniele Maglia; Elisabetta Costantini
RESULTS: Between 2011 and 2016, a total of 175 patients underwent robotic sacrocolpopexy for POP-Q Stage IV VVP. 50 patients undergoing repair with a heavy mesh weight (52 g/m2, 527 microns thick, and a suture pull out strength of 18.3 N) were matched to 50 patients undergoing repair with a lighter weight mesh ( 25 g/m2, 200 microns thick, and suture pull out strength of 23.3 N). At two year followup, anatomic success for apical prolapse was 100% and 2 patients (4%) in each group were found to have residual Grade 2 anterior prolapse and 2 patients (4%) in each group found to have Grade 2 posterior prolapse. De novo SUI was found in 5 patients (10%) in the heavy mesh group and 4 patients (8%) in the lighter mesh group. All de novo SUI patients did not have a mid urethral sling, MUS, placed at the time of the procedure. There was one mesh erosion in the light weight mesh group in a salvage patient that underwent concomitant pre-existing mesh removal at the time of surgery. CONCLUSIONS: Although the two Y-meshes are markedly different in their weight, surface area, thickness and suture pullout strength, there was no observed significant difference in the anatomic success of repair, the rate of de novo stress urinary incontinence or mesh erosion. The rates of de novo SUI seen in this study, have led us to perform a MUS procedure at the time of sacrocolpopexy for all Grade IV prolapse patients.
Urologia Internationalis | 2016
Luigi Mearini; Elisabetta Nunzi; Manuel Di Biase; Elisa Silvi; Ilaria Sabatini; Massimo Porena
Objectives: The current report describes the feasibility of robotic retroperitoneal lymph node dissection (RRPLND), including some technical tricks for port placement for both right- and left-sided surgery. Methods: Patients with advanced stage retroperitoneal disease underwent RRPLND using the 4-arm da Vinci Si Surgical System (Intuitive Surgical, Inc.). In both cases, the field of dissection was an ipsilateral template for lymph node dissection. Results: RRPLND in such configuration was safe and effective in both cases. The illustrated port placement with perpendicular docking of the robot allowed for a wide range of motion with limited external clashing, providing sufficient space for the assistant surgeon. The operative time was 300 min (including docking and console time), with no perioperative complications and short hospital stay. Conclusion: The port configuration for right- or left-sided unilateral template RRPLND was feasible, permitting a wide range of motion for the robotic arms and thus facilitating an efficient and safe dissection.
The Journal of Urology | 2015
Tony Nimeh; Elisabetta Constantini; Whitney Halgrimson; Manuel Di Biase; Ervin Kocjancic
Introduction Urethral mesh erosion is an uncommon complication after surgical correction of urinary incontinence. We present the case of a 45 year-old woman who presented with 3 years of persistent urethral pain, voiding dysfunction and stress incontinence following transobturator tape placement for severe stress incontinence. She had been previously managed with with pain medication including Pregabalin for neuropathic pain. A cystogram was unremarkable but cystoscopy revealed an intra-urethral mesh with stones at the level of the distal urethra. We present a video demonstrating the surgical technique of a transvaginal approach to urethral reconstruction for urethral mesh extrusion.
The Journal of Urology | 2014
Manuel Di Biase; Eleonora Salvini; Michele Del Zingaro; Vittorio Bini; Amelia Pietropaolo; Elena Sarti; Elisabetta Costantini
INTRODUCTION AND OBJECTIVES: Sacral nerve stimulation (SNS) (InterStim , Medtronic, Inc., Minneapolis, MN) has been used as a second-line therapy for both urinary and bowel control. There is limited data in the literature regarding trends of utilization of SNS to explore precisely who is treated with SNS. We sought to explore disparities in the utilization of SNS among Medicare beneficiaries. METHODS: A 5% national random sample of all Medicare claims for 2001, 2004, 2007, and 2010 was queried to identify patients of interest. All patients with an International Classification of Diseases, 9th Edition (ICD-9) diagnosis code that was a potential indication for SNS system were included. Patients who underwent SNS implantation were identified with Current Procedure Terminology (CPT-4) codes. Statistical tests used included the c2 and Fisher tests, as well as multivariate logistic regression analyses using SAS v9.3 (SAS Institute Inc., Cary, NC) and SPSS v20 (IBM Corp., Armonk, NY). RESULTS: A total of 3,198,300 patients were identified with a diagnosis that could potentially be treated with SNS. Of these patients, 14,780 patients underwent treatment with SNS (0.46%). The percentage of patients diagnosed who ultimately underwent treatment increased from 0.02% to 0.75% (p <0.001) over the 10-year study period. On logistic regression analysis, women (OR1⁄44.60, p<0.0001) and patients aged less than 65 years (OR1⁄41.00, compared to older age groups OR1⁄40.29-0.44, p<0.0001) were more likely to be treated with SNS. Non-white individuals (OR1⁄40.48, p<0.0001) and those living in the western U.S. (OR1⁄40.55, p<0.0001) were less likely to receive surgical treatment (see Table). CONCLUSIONS: The usage of SNS among patients diagnosed with a potential indication has significantly increased among Medicare beneficiaries over a 10-year period. Patients were more likely to be treated with SNS if they were female, white, were <65 years of age, and lived outside of the west coast of the U.S. Knowledge of these data might promote more equal access to SNS nationwide.
Archivio Italiano di Urologia e Andrologia | 2013
Emanuela Frumenzio; Daniele Maglia; Eleonora Salvini; Silvia Giovannozzi; Manuel Di Biase; Vittorio Bini; Elisabetta Costantini
OBJECTIVE Aim of this study is to evaluate the efficacy of a phytotherapic which includes Solidago, Orthosiphon and Birch extract (Cistimev®) in association with antibiotic prophylaxis in female patients affected by recurrent urinary tract infections (UTIr). MATERIALS AND METHODS Patients affected by UTIr older than 18 years started a 3-months antibiotic prophylaxis (Prulifloxacin 600 mg, 1 cps/week or Phosphomicyn 1 cachet/week) according to antibiogram after urine culture. The patients were divided in 2 groups: Group A: antibiotic prophylaxis plus phytotherapy (1 cps/die for 3 months) and Group B: antibiotic prophylaxis alone. RESULTS 164 consecutive patients were studied: 107 were included in group A (mean age 59 ± 17.3 years) and 57 (mean age 61 ± 15.7) in group B. During the treatment period the relapse frequencies between the two groups were not significantly different (p = 0.854): 12/107 (11.21%) patients interrupted the treatment for UTIr in group A and 6/57 (10.52%) in group B. In the long term follow-up the relapse UTI risk was significant different in the two groups with a relapse risk 2.5 greater in group B than in group A (p < 0.0001). CONCLUSION Our study demonstrated that in female patients affected by recurrent UTI, the association between antibiotic prophylaxis and of a phytotherapic which includes Solidago, Orthosiphon and Birch extract reduced the number of UTI in the 12 months following the end of prophylaxis and obtained a longer relapsing time, greatly improving the quality of life of the patients.