Publications by authors named "Davide Arcaniolo"

34 Publications

Premature Ejaculation patients and their partners: arriving at a clinical profile for a real optimization of the treatment.

Arch Ital Urol Androl 2021 Mar 18;93(1):42-47. Epub 2021 Mar 18.

Department of Neurosciences, Reproductive Sciences and Odontostomatology, Urology Section, University of Naples Federico II, Naples.

The aim of the study is to extrapolate clinical features of Premature Ejaculation (PE) patients and female partners of men affected with PE, in order to get a profile that can be of assistance for physicians within the dynamics of a couple, one of which is a PE patient. An observational, non-interventional, cross-sectional epidemiological study entitled IPER (Italian Premature Ejaculation Research) was conducted and included two different cohorts of subjects that were randomly sampled from a patient dataset of selected General Practitioners: 1. IPER-M sub-cohort (1.104 subjects) was made of male subjects in which they were then distinguished patients with or without PE based on the score of the PEDT questionnaire; IPER-F sub-cohort (1.109 subjects) was made of female subjects from an independent sample of women (therefore not the partners of the IPER-M males) in which they then distinguished those partners of a male subject with PE or not. In addition to an identical general questionnaire to explore demographic aspects and habits, each subcohort was then evaluated using validated questionnaires. No differences were noted between PE+/PE- patients in terms of alcohol consumption, smoking habits, physical activity nor stress condition in everyday life, employment, socio-economic class and marital status. While the prevalence of PE proportionally increased with age, excluding the 50-59 and 70-80 years decades, in the IPER-M group an overall statistically significant difference for the mean age between the PE+ and PE- groups (p = 0.002) was detected, but without reaching any difference amongst the different age classes in the IPER-F group. The PE+ patients reported a significantly lower frequency rate of sexual intercourse, worse QoL (p = 0.006 and p < 0.0001, respectively), and increased anxiety status (p < 0.0001 for both subgroups). This study shows that, rather than talking with a patient affected by PE it would be advisable to introduce the concept of couple counseling with the person patient and his partner, because it is only through classification of both partners as one couple and a full understanding of their mutual sexual experience that PE treatment can be optimized and its results measured accurately.
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http://dx.doi.org/10.4081/aiua.2021.1.42DOI Listing
March 2021

How Can the COVID-19 Pandemic Lead to Positive Changes in Urology Residency?

Front Surg 2020 24;7:563006. Epub 2020 Nov 24.

Department of Urology, IEO European Institute of Oncology IRCCS, Milan, Italy.

The COVID-19 outbreak, in a few weeks, overloaded Italian hospitals, and the majority of medical procedures were postponed. During the pandemic, with hospital reorganization, clinical and learning activities performed by residents suffered a forced remodulation. The objective of this study is to investigate how urology training in Italy has been affected during the COVID-19 era. In this multi-academic study, we compared residents' training during the highest outbreak level with their previous activity. Overall 387 (67.1%) of the 577 Italian Urology residents participated in a 72-h anonymous online survey with 36 items sent via email. The main outcomes were clinical/surgical activities, social distancing, distance learning, and telemedicine. Clinical and learning activity was significantly reduced for the overall group, and after categorizing residents as those working only in COVID hospitals, both "junior" and "senior" residents, and those working in any of three geographical areas created (Italian regions were clustered in three major zones according to the prevalence of COVID-19). A significant decrease in outpatient activity, invasive diagnostic procedures, and endoscopic and major surgeries was reported. Through multivariate analysis, the specific year of residency has been found to be an independent predictor for all response modification. Being in zone 3 and zone 2 and having "senior" resident status were independent predictors associated with a lower reduction of the clinical and learning activity. Working in a COVID hospital and having "senior" resident status were independent predictors associated with higher reduction of the outpatient activity. Working in zone 3 and having "senior" resident status were independent predictors of lower and higher outpatient surgical activity, respectively. Working in a COVID hospital was an independent predictor associated with robotic surgical activity. The majority of residents reported that distance teaching and multidisciplinary virtual meetings are still not used, and 44.8% reported that their relationships with colleagues decreased. The COVID-19 pandemic presents an unprecedented challenge, including changes in the training and education of urology residents. The COVID era can offer an opportunity to balance and implement innovative solutions that can bridge the educational gap and can be part of future urology training.
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http://dx.doi.org/10.3389/fsurg.2020.563006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7732553PMC
November 2020

Recent advances in percutaneous lithotripsy techniques.

Curr Opin Urol 2021 Jan;31(1):24-28

Urology Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania 'Luigi Vanvitelli'.

Purpose Of Review: To describe and critically discuss the most recent evidence regarding the percutaneous nephrolithotomy (PCNL) techniques.

Recent Findings: Three-dimensional printing and virtual reality are promising tools to improve surgeon experience and operative performance. Totally ultrasound-guided PCNL is feasible and can reduce the radiological risk. Growing evidence highlights the safety and advantages of the use of miniaturized instrumentations, although some related limitations place the mini PCNL (mPCNL) in direct challenge with the retrograde intrarenal surgery. LithoClast Trilogy and ClearPetra system can improve the stone clearance. Thulium laser is a new source of energy with growing expectations and promising in-vitro results.

Summary: Significant advances have recently been recorded in PCNL techniques. Thulium fiber laser, LithoClast Trilogy, new suction devices, and the development of novel technologies for teaching and planning procedures may overcome mPCNL drawbacks. Further studies are needed to confirm the promising preliminary results available on the topic.
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http://dx.doi.org/10.1097/MOU.0000000000000829DOI Listing
January 2021

Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial.

Int J Impot Res 2020 Jul 18. Epub 2020 Jul 18.

Department of Urology, Santa Chiara Regional Hospital, Trento, Italy.

Low-intensity shockwave therapy (Li-ESWT) has been shown to be an effective and safe treatment for vasculogenic erectile dysfunction (ED). We aim to evaluate the effectiveness and safety of LiESWT in treating patients affected from vasculogenic ED who did not respond to oral treatment with Phosphodiesterase 5 inhibitors (PDE5-i). It is a multicentric open-label prospective study, in a cohort of patients non-responders to PDE-5i. Li-ESWT was performed in an outpatient setting by using the following schedule: 3000 shockwaves with an energy of 0.25 mJ/mm and a frequency of 4-6 Hz, twice a week for 3 weeks. International Index of Erectile Function, Erection Hardness Score and Sexual Quality of Life-Male questionnaires, and penile doppler ultrasound (PDU) are the outcome measurements. The Student t-test or Wilcoxon signed-rank test were applied to compare variables, with results considered statistically significant at p < 0.05. 106 (97.2%) completed treatment and performed follow-up visit after 4 weeks. At follow up visit, the mean IIEF-EF increased by 8.6 points (13.47 ± 4.61 vs 22.07 ± 5.27; p < 0.0001). A clinically significant improvement of IIEF-EF was achieved in 75 patients (70.7%). An EHS score ≥ 3, sufficient for a full intercourse, was reported by 72 patients (67.9%) at follow-up visit. 37 (34.9%) patients reported a full rigid penis (EHS = 4) after treatment. Li-ESWT treatment was also able to improve quality of life (SQOL-M: 45.56 ± 8.00 vs 55.31 ± 9.56; p < 0.0001). Li-ESWT significantly increased mean PSV (27.79 ± 5.50 vs 41.66 ± 8.59; p < 0.0001) and decreased mean EDV (5.66 ± 2.03 vs 1.93 ± 2.11; p < 0.0001) in PDU. Combination of Li-ESWT and PDE5-i represents an effective and safe treatment for patients affected from ED who do not respond to first line oral therapy.
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http://dx.doi.org/10.1038/s41443-020-0332-7DOI Listing
July 2020

COVID-19 pandemic and its implications on sexual life: Recommendations from the Italian Society of Andrology.

Arch Ital Urol Androl 2020 Jun 23;92(2). Epub 2020 Jun 23.

Department of Andrology, CIRM Medical Center, Piacenza.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the coronavirus that causes an infectious disease, called COVID-19, first detected in patients with pneumonia in Wuhan (People's Republic of China) on December 2019. Italy was the first European country to state the outbreak of the infection and its Council of Ministers declared the state of health emergency on 31.01.2020, then the World Health Organization ruled a global pandemic on 11.03.2020. The nasopharyngeal swab is based on the detection of virus RNA and is the only reliable one for declaring COVID-19 infection. The most common symptoms observed in COVID-19 patients before hospitalization may be fever, chills, cough, dyspnea, asthenia, myalgia and/or arthralgia. This symptomatology can be often complicated in a dramatically increasing manner such as to require hospitalization starting from the third-fourth week. COVID-19 outbreak has dramatically affected the quality of life by changing inter-personal relationships, community life and obviously sexual health. The purpose of this work, based on available evidence, is to provide recommendations to help the population to face their sexual life in this critical period.
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http://dx.doi.org/10.4081/aiua.2020.2.73DOI Listing
June 2020

Hyperbaric oxygen therapy reduces mortality in patients with Fournier's Gangrene. Results from a multi-institutional observational study.

Minerva Urol Nefrol 2020 Apr 19;72(2):223-228. Epub 2020 Feb 19.

Department of Neurosciences, Sciences of Reproduction, and Odontostomatology, Federico II University, Naples, Italy -

Background: Evidence about the clinical benefits of Hyperbaric Oxygen Therapy (HBOT) in patients with Fournier's Gangrene (FG) is controversial and inconclusive. We aimed to compare the mortality related to FG between patients undergoing surgical debridement and/or standard antibiotic therapy alone or in combination with HBOT.

Methods: We performed a retrospective multi-institutional observational case-control study. All patients admitted with diagnosis of FG from June 2009 to June 2019 were included into the study. Patients received surgical debridement and/or standard antibiotic therapy alone or in combination with HBOT. Factors associated with FG related mortality were assessed with uni-and multivariate analyses. The main outcome measure was FG related mortality.

Results: A total of 161 patients with diagnosis of FG were identified. Mean FG Severity Index was 8.6±4.5. All patients had broad-spectrum parenteral antibiotic therapy. An aggressive debridement was performed in 139 (86.3%) patients. A total of 72 patients (44.7%) underwent HBOT. Mortality due to FG was observed in 32 (36.0%) of patients who do not underwent HBOT and in 14 (19.4%) of patients who underwent HBOT (P=0.01). At the multivariate analysis, surgical debridement and HBOT were independent predictors of lower mortality while higher FG Severity Index was independent predictor of higher mortality.

Conclusions: HBOT and surgical debridement are independent predictors of reduced FG related mortality.
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http://dx.doi.org/10.23736/S0393-2249.20.03696-6DOI Listing
April 2020

Clinical Efficacy of Silodosin in Patients with Severe Lower Urinary Tract Symptoms Related to Benign Prostatic Obstruction: A Pooled Analysis of Phase 3 and 4 Trials.

Eur Urol Focus 2021 Mar 10;7(2):440-443. Epub 2020 Feb 10.

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II, Naples, Italy. Electronic address:

We performed a post hoc analysis of data from phase 3 and 4 studies to evaluate the efficacy of silodosin 8mg in patients with severe lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO). The presence of two or more of the following criteria was adopted to define severity: total International Prostate Symptom Score (IPSS) 20-35, quality of life (QoL) score 5-6, maximum urinary flow <5ml/s or postvoid residual volume ≥100ml, and prostate volume ≥50ml. Mean improvements in total (8.1 vs 4.7), storage (3.1 vs 2.0), voiding (5.0 vs 2.7), and QoL (1.3 vs 0.7) IPSS scores were significantly greater for patients receiving silodosin compared to placebo (all p< 0.0001). Mean improvements in total, storage, voiding, and QoL IPSS scores were similar for the severe and not severe LUTS cohorts. In conclusion, silodosin significantly improves symptoms and QoL in all LUTS/BPO patients, including those with severe symptoms. PATIENT SUMMARY: Silodosin improves symptoms and quality of life for patients with severe lower urinary tract symptoms related to benign prostatic obstruction.
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http://dx.doi.org/10.1016/j.euf.2020.01.014DOI Listing
March 2021

Detrusor overactivity and underactivity: implication for lower urinary tract symptoms related to benign prostate hyperplasia diagnosis and treatment.

Minerva Urol Nephrol 2021 Feb 30;73(1):59-71. Epub 2020 Jan 30.

Unit of Urology, Department of Neurosciences, Sciences of Reproduction, and Odontostomatology, Federico II University, Naples, Italy -

Introduction: Detrusor underactivity (DUA) and detrusor overactivity (DO) have potential impact on the outcomes of surgery for lower urinary tract symptoms related to benign prostate hyperplasia (LUTS/BPH).

Evidence Acquisition: We performed a literature search including studies on humans enrolling patients with preoperative urodynamic evidence of DO and/or DUA undergoing LUTS/BPH surgery. Factors that may influence the outcomes of surgery in these patients were evaluated.

Evidence Synthesis: In patients with DUA mean bladder contractility index improved from +4 to +44.6, mean total International Prostate Symptom Score (IPSS) improved from -3 to -19.5 points, mean maximum urinary flow (Qmax) improved from +1.4 to +11.7 mL/s, and mean postvoid residual volume (PVR) improved from -16.5 to -736 mL. Older age, lack of obstruction, concomitant DO, lower detrusor contractility and use of transurethral resection of the prostate (TURP) or photovaporization (PV) instead of Holmium laser enucleation of the prostate (HoLEP) were associated with worse outcomes. In patients with DO, the percentage of DO resolution ranged from 57.1% to 83.3%. Mean total IPSS, Qmax, and PVR variations ranged from +0.9 to -15.7 points, from -0.2 mL/s to +14 mL/s, and from -19.6 to -202.5 mL, respectively. Older age, lack of obstruction, terminal DO, low maximum cystometric capacity, early and high amplitude DO, and use of transurethral prostate incision instead of TURP or open adenomectomy were associated with worse outcomes.

Conclusions: In patients with DUA or DO, surgery for LUTS/BPH provides overall good results. However, a number of factors can affect these outcomes.
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http://dx.doi.org/10.23736/S0393-2249.20.03678-4DOI Listing
February 2021

Second cycle of intralesional Collagenase Clostridium histolyticum for Peyronie's disease using the modified shortened protocol: Results from a retrospective analysis.

Andrologia 2020 Apr 31;52(3):e13527. Epub 2020 Jan 31.

Urology Unit, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples "Federico II", Naples, Italy.

The purpose of this study was to evaluate the effectiveness and safety of the second cycle of Collagenase Clostridium histolyticum injections using the modified shortened protocol. We performed a retrospective analysis on patients who had already undergone the first cycle of injections using the modified shortened protocol and requested more injections to improve the remaining curvature. The International Index of Erectile Function, the Peyronie's Disease Questionnaire and the Global Assessment of Peyronie's Disease questionnaire were self-administered to all patients. All the parameters were recorded at baseline, after the first cycle and after the second cycle of injections. All adverse events were recorded. Seventeen patients completed two cycles of injections. All patients had a reduction of the initial curvature after the first cycle, with a mean improvement of 17.4° (27.4%). After the second cycle, the reduction of the curvature was 7.9° (17.1%), and 29.4% of patients had no further improvement. No severe side effect was recorded. The results of the present study confirm the effectiveness and safety of the modified shortened protocol of Collagenase C. histolyticum injections for Peyronie's disease. However, the second cycle of three injections may be less effective, and patients may not be completely satisfied.
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http://dx.doi.org/10.1111/and.13527DOI Listing
April 2020

Is topical alprostadil an usable and reliable alternative to intracavernous injection for penile dynamic duplex ultrasonography?

Andrologia 2020 Mar 11;52(2):e13480. Epub 2019 Nov 11.

Department of Neurosciences, Reproductive Sciences, and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy.

No study has yet been done to evaluate topical alprostadil as a less invasive alternative vasoactive agent for Penile Dynamic Duplex Ultrasonography (PDDU) in the diagnosis of erectile dysfunction. The main aim of our study was to evaluate the usability and reliability of topical alprostadil for PDDU compared with standard intracavernous injection. A further objective was to determine the patients' preference between these two different approaches. During session A, patients received injection while during session B, they received topical alprostadil. Each patient underwent both sessions, 1 week apart from the other. A total of 80 patients were enrolled. After 20 min from drug administration, no significant difference was found between the two procedures in terms of peak systolic velocity and end-diastolic velocity, while Erection Hardness Score was significantly higher with injection. Patients reported less pain/discomfort during the procedure in case of topical alprostadil use and an overall preference towards this examination modality. Topical alprostadil could represent a usable and reliable alternative to intracavernous injection for PDDU, with less discomfort and greater preference by patients.
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http://dx.doi.org/10.1111/and.13480DOI Listing
March 2020

Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis.

World J Urol 2020 May 25;38(5):1177-1186. Epub 2019 Jul 25.

Urology Unit, Luigi Vanvitelli University, Naples, Italy.

Purpose: To perform a cumulative analysis of the current evidence on the surgical and functional outcomes of bipolar endoscopic enucleation of the prostate (b-EEP) versus bipolar transurethral resection of the prostate (b-TURP).

Methods: A systematic review of the literature was performed on PubMed, Ovid, and Scopus according to Preferred Reporting Items for Systematic Review and Meta-analysis Statement (PRISMA Statement). The meta-analysis was conducted using the Review Manager 5.3 software. Parameters of interest were surgical and functional outcomes. Weighted mean difference, and odds ratio with 95% confidence interval were calculated for continuous and binary variables, respectively. Pooled estimates were calculated using the random-effect model.

Results: Fourteen comparative studies were included. No statistically significant difference in terms of overall baseline characteristics was found. b-EEP had higher amount of resected tissue (p < 0.0001), shorter catheter time (p = 0.006), lower Hb drop (p = 0.03), and shorter length of stay (p < 0.0001). Equally, overall post-operative complications were lower (p = 0.01) as well as short (p = 0.04), and long-term complication rate (p = 0.04). There was higher re-intervention rate in the b-TURP group (p = 0.02) whereas b-EEP group had smaller residual prostate volume (p = 0.03), and lower post-operative PSA values (p < 0.00001). At long term, b-EEP presented lower IPSS (p = 0.04), higher Q (p = 0.002), and lower PVR (p < 0.00001).

Conclusions: b-EEP is an effective and safe surgical treatment for BPO. This procedure might offer several advantages over standard b-TURP, including the resection of a larger amount of tissue within the same operative time, shorter hospitalization, lower risk of complications, and lower re-intervention rate. This was submitted to PROSPERO registry: CRD42019126748.
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http://dx.doi.org/10.1007/s00345-019-02890-9DOI Listing
May 2020

46,XX Testicular Disorder of Sex Development (DSD): A Case Report and Systematic Review.

Medicina (Kaunas) 2019 Jul 12;55(7). Epub 2019 Jul 12.

Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania "Luigi Vanvitelli", 80131 Naples, Italy.

XX male syndrome is part of the disorders of sex development (DSD). The patients generally have normal external genitalia and discover their pathology in adulthood because of infertility. There are no guidelines regarding XX male syndrome, so the aim of our study was to evaluate the literature evidence in order to guide the physicians in the management of these type of patients. We performed a systematic review of the available literature in September 2018, using MEDLINE, Web of Science, Embase and Google Scholar database to search for all published studies regarding XX male syndrome according to PRISMA guidelines. The following search terms were used: "46 XX male", "DSD", "infertility", "hypogonadism". After appropriate screening we selected 37 papers. Mean (SD) age was 33.14 (11.4) years. Hair distribution was normal in 29/39 patients (74.3%), gynecomastia was absent in 22/39 cases (56.4%), normal testes volume was reported in 0/14, penis size was normal in 26/32 cases (81.2%), pubic hair had a normal development in 6/7 patients (85.7%), normal erectile function was present in 27/30 cases (90%) and libido was preserved in 20/20 patients (100%). The data revealed the common presence of hypergonadotropic hypogonadism. All patients had a 46,XX karyotype. The sex-determining region Y () gene was detected in 51/57 cases. The position of the was on the Xp in the 97% of the cases. An appropriate physical examination should include the evaluation of genitalia to detect cryptorchidism, hypospadias, penis size, and gynecomastia; it is important to use a validated questionnaire to evaluate erectile dysfunction, such as the International Index of Erectile Function (IIEF). Semen analysis is mandatory and so is the karyotype test. Abdominal ultrasound is useful in order to exclude residual Müllerian structures. Genetic and endocrine consultations are necessary to assess a possible hypergonadotropic hypogonadism. Testicular sperm extraction is not recommended, and adoption or in vitro fertilization with a sperm donor are fertility options.
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http://dx.doi.org/10.3390/medicina55070371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681203PMC
July 2019

Enrichment of semen culture in the diagnosis of bacterial prostatitis.

J Microbiol Methods 2018 11 26;154:124-126. Epub 2018 Oct 26.

Department of Clinical Pathology, Virology Unit, "San Giovanni di Dio e Ruggid'Aragona Hospital", Salerno, Italy.

The objective was to investigate the diagnostic accuracy of our microbiological protocol to simplify the evaluation of bacterial prostatitis in the clinical practice. Our findings show the possibility to apply our alternative enrichment semen culture method to detect prostatic bacterial infection with higher sensitivity than the gold standard M&S technique.
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http://dx.doi.org/10.1016/j.mimet.2018.10.016DOI Listing
November 2018

Impact of Perioperative Blood Transfusions on the Outcomes of Patients Undergoing Kidney Cancer Surgery: A Systematic Review and Pooled Analysis.

Clin Genitourin Cancer 2019 02 20;17(1):e72-e79. Epub 2018 Sep 20.

Urology Unit, Luigi Vanvitelli University, Napoli, Italy; Division of Urolrogy, Department of Surgery, VCU Health, Richmond, VA; Division of Urology, McGuire VA Medical Center, Richmond, VA. Electronic address:

The aim of the present study is to systematically review current evidence regarding the association between perioperative blood transfusions (PBT) and oncological outcomes of patients with renal cell carcinoma undergoing nephrectomy procedures. A computerized bibliographic search was conducted to identify pertinent studies. The Population, Intervention, Comparator, Outcome (PICO) study design approach was used to define study eligibility according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) criteria. Only 7 studies were deemed fully eligible for analysis. Most series included both open and laparoscopic cases. The rate of PBT varied between 9.6% and 76.6%, and the median number of transfused units was 2 for most of the studies. At pooled analysis, a statistically significant association was found between PBT and disease recurrence (HR, 1.79; 95% CI, 1.32-2.41; P < .001), cancer-specific mortality (HR, 1.62; 95% CI, 1.29-2.05; P ≤ .001), and all-cause mortality (HR, 1.45; 95% CI, 1.25-1.69; P < .001). Current evidence suggests that indeed the use of PBT may be associated with worse oncologic outcomes in patients with renal cell carcinoma undergoing nephrectomy procedures. Although presents findings should be interpreted within the intrinsic limitations of this type of pooled analysis, they emphasize the need for evidence-based strategies to minimize the use of PBT during kidney cancer surgery.
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http://dx.doi.org/10.1016/j.clgc.2018.09.010DOI Listing
February 2019

Premature Ejaculation Among Italian Men: Prevalence and Clinical Correlates From an Observational, Non-Interventional, Cross-Sectional, Epidemiological Study (IPER).

Sex Med 2018 Sep 24;6(3):193-202. Epub 2018 May 24.

Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II," Naples, Italy.

Introduction: There is a great variability in the prevalence of premature ejaculation (PE) worldwide and only few data are available about the Italian population.

Aim: To determine the prevalence of PE in the adult male population in Italy.

Methods: Adult men 18 to 80 years old who were sexually active were randomly sampled from patient lists of general practitioners in Italy and were included in this observational, non-interventional, cross-sectional epidemiologic study from January to July 2015.

Main Outcome Measures: Subjects were asked to complete general questionnaires on anthropometric data, lifestyle, education, occupation, economic conditions, general health status, comorbidities, and sexual habits: the Premature Ejaculation Diagnostic Tool (PEDT), the 5-item International Index of Erectile Function, and the Sexual Quality of Life Questionnaire-Male.

Results: 1,104 subjects were recruited. Mean age was 45.6 years. Mean prevalence of PE based on PEDT score (≥11) was 18.5%, and 12.4% self-reported an intravaginal ejaculatory latency time shorter than 1 minute. Prevalence of PE proportionally increased with age. 64.6% of patients presented lifelong PE vs 35.4% of patients who reported acquired PE. Estimated prevalence of coexisting PE and erectile dysfunction was 7.0%. Furthermore, overall quality of sexual life was significantly worse in men with PE (P = .006). Enrolled men reported an overall rate of sexual problems in their partners of approximately 30%. 31.3% of patients with PE did not seek help for their dysfunction. No significant differences were noted between patients with and without PE for body mass index, alcohol consumption, smoking habits, physical activity, education, economic conditions, and marital status.

Conclusions: PE has a high prevalence in the Italian male population, increases with age, and heavily affects quality of life in patients and their partners. Encouraging data exist concerning the percentage of patients seeking help for their condition. Verze P, Arcaniolo D, Palmieri A, et al. Premature Ejaculation Among Italian Men: Prevalence and Clinical Correlates From an Observational, Non-Interventional, Cross-Sectional, Epidemiological Study (IPER). Sex Med 2018;6:193-202.
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http://dx.doi.org/10.1016/j.esxm.2018.04.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6085227PMC
September 2018

Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study.

J Sex Med 2018 05;15(5):716-721

Department of Urology, Santa Maria Annunciata Hospital, Florence, Italy.

Background: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD).

Aim: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners' bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center.

Methods: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections.

Outcomes: International Index of Erectile Function (IIEF)-15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment.

Results: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF-15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF-total and all domains significantly improved after treatment (all P < .01). A PC mean change of 19.07 (P = .00) was measured. At the univariate linear regression analysis, IIEF-15, IIEF-erectile function, IIEF-sexual desire, and IIEF-intercourse satisfaction were positively associated with FSFI (all P ≤ .03); conversely, PDQ-penile pain, PDQ-symptom bother, and post-treament penile curvature (P ≤ .04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02-0.11; P = .004). Global satisfaction after treatment was 89.6% (121/135).

Clinical Translation: This modified CCH treatment protocol could improve both patients' and partner's sexual function.

Strength And Limitations: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account.

Conclusions: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients' and partners' sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716-721.
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http://dx.doi.org/10.1016/j.jsxm.2018.03.084DOI Listing
May 2018

Urine Proteomics Revealed a Significant Correlation Between Urine-Fibronectin Abundance and Estimated-GFR Decline in Patients with Bardet-Biedl Syndrome.

Kidney Blood Press Res 2018 8;43(2):389-405. Epub 2018 Mar 8.

Division of Nephrology, Department of Cardio-thoracic and Respiratory Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Background: /Aims: Renal disease is a common cause of morbidity in patients with Bardet-Biedl syndrome (BBS), however the severity of kidney dysfunction is highly variable. To date, there is little information on the pathogenesis, the risk and predictor factors for poor renal outcome in this setting. The present study aims to analyze the spectrum of urinary proteins in BBS patients, in order to potentially identify 1) disease-specific proteomic profiles that may differentiate the patients from normal subjects; 2) urinary markers of renal dysfunction.

Methods: Fourteen individuals (7 males and 7 females) with a clinical diagnosis of BBS have been selected in this study. A pool of 10 aged-matched males and 10 aged-matched females have been used as controls for proteomic analysis. The glomerular filtration rate (eGFR) has been estimated using the CKD-EPI formula. Variability of eGFR has been retrospectively assessed calculating average annual eGFR decline (ΔeGFR) in a mean follow-up period of 4 years (3-7).

Results: 42 proteins were significantly over- or under-represented in BBS patients compared with controls; the majority of these proteins are involved in fibrosis, cell adhesion and extracellular matrix organization. Statistic studies revealed a significant correlation between urine fibronectin (u-FN) (r2=0.28; p<0.05), CD44 antigen (r2 =0.35; p<0.03) and lysosomal alfa glucosidase ( r20.27; p<0.05) abundance with the eGFR. In addition, u-FN (r2 =0.2389; p<0.05) was significantly correlated with ΔeGFR.

Conclusion: The present study demonstrates that urine proteome of BBS patients differs from that of normal subjects; in addition, kidney dysfunction correlated with urine abundance of known markers of renal fibrosis.
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http://dx.doi.org/10.1159/000488096DOI Listing
October 2018

Increased risk of erectile dysfunction in men with multiple sclerosis: an Italian cross-sectional study.

Cent European J Urol 2017 4;70(3):289-295. Epub 2017 Aug 4.

Urology Service, University of Campania L. Vanvitelli, Naples, Italy.

Introduction: Sexual dysfunctions (SDs) are common, but often underestimated symptoms in men with multiple sclerosis (MS). The most common sexual complaint in a multiple sclerosis male is erectile dysfunction (ED). The aim of this observational, cross-sectional study was to assess the prevalence of erectile dysfunction (ED) and its relationship with neurological disability, depression, urodynamic findings and lower urinary tract symptoms (LUTS) in these patients.

Material And Methods: From January 2014 to January 2016, there were 101 consecutive male patients with a diagnosis of Multiple Sclerosis according to the McDonald revised criteria and stable sexual relationships were included. Patients were evaluated with the International Index of Erectile Function (IIEF-15), Sexual Quality of Life Questionnaire-Male version (SQoL-M), International Prostate Symptom Score (I-PSS) and the Beck Depression Inventory-II (BDI-II). Neurological impairment was assessed using the Expanded Disability Status Scale (EDSS). The presence of Detrusor Overactivity (DO), Detrusor Underactivity (DU) and Detrusor Sphincter Dyssynergia (DSD), was defined by International Continence Society (ICS) criteria.

Results: Erectile dysfunction (ED) defined according to the erectile function (EF)-subdomain score ≤25 was present in 75 patients (74.25%). Univariate regression analysis showed that Sexual Quality of Life Questionnaire-Male version (P <0.0001), age (P = 0.021), Expanded Disability Status Scale score (P = 0.001), Beck Depression Inventory-IIscore (P = 0.001),International Prostate Symptom Score (P = 0.001), Detrusor Underactivity (P = 0.002), Multiple Sclerosis-Secondary Progressive (P = 0.002) was significantly associated with erectile dysfunction. All significant findings in univariate analysis were then entered into a multiple logistic regression model. The results indicated that the Beck Depression Inventory-II score (P = 0.011) and International Prostate Symptom Score (P = 0.043) were the only independent predictive factors of erectile dysfunction onset in these patients.

Conclusions: Hence, in order to provide an effective approach and management for erectile dysfunction all the mentioned symptoms and clinical variables should be kept in mind.
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http://dx.doi.org/10.5173/ceju.2017.1380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5656369PMC
August 2017

Scrotal Abscess Drained by Iatrogenic Urethral Fistula in an Adult Diabetic Male.

Case Rep Urol 2017 17;2017:9820245. Epub 2017 Jul 17.

Urology Unit, University of Campania "Luigi Vanvitelli", Naples, Italy.

A 46-year-old Caucasian male has been transferred to our urology department with a history of septic fever, uncompensated diabetes, pain, and scrotal swelling. On clinical examination, the left inguinal and scrotal area was swollen, tender, and painful; scrotal MR had been performed, showing the catheter tip in scrotal cavity and presence of gas. The case was diagnosed as scrotal abscess with urethroscrotal fistula. He was successfully treated with scrotal incision, drainage, catheter repositioning under fluoroscopic control, antibiotics, and insulin. This patient developed an infection of scrotum, which led to subcutaneous abscess getting worse by a poorly controlled glycemia. In this case, an iatrogenic fistula, caused by wrong catheterization, stops the evolving to a Fournier's Gangrene. Early detection and intervention provide opportunities to improve outcome of this disease.
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http://dx.doi.org/10.1155/2017/9820245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5535698PMC
July 2017

Knowledge, attitudes, and practices towards prostate cancer screening amongst men living in the southern Italian peninsula: the Prevention and Research in Oncology (PRO) non-profit Foundation experience.

World J Urol 2017 Dec 5;35(12):1857-1862. Epub 2017 Aug 5.

Urology Unit, Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Università degli studi di Napoli "Federico II", Via Sergio Pansini, 5, 80131, Naples, Italy.

Purpose: We aimed to explore the knowledge, attitudes, and practices towards prostate cancer (PCa) risk factors and prevention amongst men living in the southern Italian peninsula.

Methods: We retrospectively reviewed data collected during free preventive visits carried out by the Prevention and Research in Oncology (PRO) non-profit Foundation between July 2013 and July 2016. The following data were collected: demographic and clinical features, knowledge about PCa prevention and sources of knowledge, knowledge about PCa risk factors, previous prostate-specific antigen (PSA) test, previous digital rectal examination (DRE), previous prostate ultrasound, and general attitudes towards DRE.

Results: The study population consisted of 2144 Caucasian men living in four regions in the south of Italy (Campania, Calabria, Molise, Puglia). Median age was 59 years. One thousand six hundred and ninety-nine (79.2%) subjects reported knowing the existence of PCa prevention programs. Most of them received information from the media while only 17.1% declared that the information on PCa prevention that they received was from their family physicians. One thousand two hundred seventy-five (59.5%) subjects declared knowing of the existence of PCa risk factors and 41.3% was aware of the existence of both genetic and exogenous factors. The percentage of subjects who reported having had at least one PSA test in their life was 77.8 and 55.4% reported having had a DRE.

Conclusions: Knowledge about PCa screening amongst male subjects living in southern peninsular Italy is quite high. Knowledge of PCa risk factors is suboptimal and the practice of DRE is underutilized.
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http://dx.doi.org/10.1007/s00345-017-2074-9DOI Listing
December 2017

Emergent versus delayed lithotripsy for obstructing ureteral stones: a cumulative analysis of comparative studies.

Urolithiasis 2017 Dec 23;45(6):563-572. Epub 2017 Feb 23.

Urology Unit, Second University of Naples, Naples, Italy.

Objective: To analyze the current evidence on the use of ureteroscopy (URS) and extracorporeal shock wave lithotripsy (ESWL) for the management of obstructing ureteral stones in emergent setting.

Methods: A systematic literature review was performed up to June 2016 using Pubmed and Ovid databases to identify pertinent studies. The PRISMA criteria were followed for article selection. Separate searches were done using a combinations of several search terms: "laser lithotripsy", "ureteroscopy", "extracorporeal shock wave lithotripsy", "ESWL", "rapid", "immediate", "early", "delayed", "late", "ureteral stones", "kidney stones", "renal stones". Only titles related to emergent/rapid/immediate/early (as viably defined in each study) versus delayed/late treatment of ureteral stones with either URS and/or ESWL were considered for screening. Demographics and operative outcomes were compared between emergent and delayed lithotripsy. RevMan review manager software was used to perform data analysis.

Results: Four studies comparing emergent (n = 526) versus delayed (n = 987) URS and six studies comparing emergent (n = 356) versus delayed (n = 355) SWL were included in the analysis. Emergent URS did not show any significant difference in terms of stone-free rate (91.2 versus 90.9%; OR 1.04; CI 0.71, 1.52; p = 0.84), complication rate (8.7% for emergent versus 11.5% for delayed; OR 0.94; CI 0.65, 1.36; p = 0.74) and need for auxiliary procedures (OR 0.85; CI 0.42, 1.7; p = 0.85) when compared to delayed URS. Emergent ESWL was associated with a higher likelihood of stone free status (OR 2.2; CI 1.55, 3.17; p < 0.001) and a lower likelihood of need for auxiliary maneuvers (OR 0.49; CI 0.33, 0.72; p < 0.001) than the delayed procedure. No differences in complication rates were noticed between the emergent and delayed ESWL (p = 0.37).

Conclusions: Emergent lithotripsy, either ureteroscopic or extracorporeal, can be offered as an effective and safe treatment for patients with symptomatic ureteral stone. If amenable to ESWL, based on stone and patient characteristics, an emergent approach should be strongly considered. Ureteroscopy in the emergent setting is mostly reserved for distally located stones. The implementation of these therapeutic approaches is likely to be dictated by their availability.
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http://dx.doi.org/10.1007/s00240-017-0960-7DOI Listing
December 2017

High Neutrophil-to-lymphocyte Ratio as Prognostic Factor in Patients Affected by Upper Tract Urothelial Cancer: A Systematic Review and Meta-analysis.

Clin Genitourin Cancer 2017 06 29;15(3):343-349.e1. Epub 2016 Dec 29.

Department of Urology, ASL Abruzzo 2, Chieti, Italy.

Given the increasing interest in the possible role of the neutrophil-to-lymphocyte ratio (NLR) as an easily available oncologic marker for upper tract urothelial cancer (UTUC), we sought to quantify the prognostic effect of this biomarker and assess its consistency in UTUC. A systematic review of the published data was performed up to May 2016 using multiple search engines (PubMed, Ovid, and Scopus) to identify eligible comparative studies. A formal meta-analysis was performed for studies comparing patients with a high and those with a low NLR before surgical treatment of UTUC to determine whether the NLR is an independent predictor of survival. Pooled estimates were calculated using a fixed-effects model if no significant heterogeneity was identified. Alternatively, a random-effects model was used when significant heterogeneity was detected. For continuous outcomes, the weighted mean difference was used as a summary measure. For binary variables, the odds ratio or risk ratio was calculated with the 95% confidence intervals (CIs). Statistical analyses were performed using RevMan, version 5. Six studies with 1710 patients were included. A high NLR was associated with poorer oncologic outcomes in patients affected by UTUC, in particular in terms of overall survival (hazard ratio [HR], 1.97; 95% CI, 1.27-3.04; P = .002) and recurrence-free survival (HR, 1.53; 95% CI, 1.19-1.96; P = .0009) but not cancer-specific survival (HR, 1.25; 95% CI, 0.29-5.41; P = .77). Current evidence suggests that the NLR might have an independent role as a prognostic factor in patients affected by UTUC undergoing surgical treatment. The NLR potentially represents an easily available measurement of prognosis; however, it requires validation in larger prospective studies.
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http://dx.doi.org/10.1016/j.clgc.2016.12.027DOI Listing
June 2017

Prevalence of chronic prostatic inflammation based on clinical diagnostic criteria in a real-practice setting: a nation-wide observational study.

Minerva Urol Nefrol 2017 Oct 24;69(5):509-518. Epub 2017 Jan 24.

SIUT, Nola, Italy.

Background: Chronic prostatic inflammation has a key role in the pathogenesis and progression of benign prostatic hyperplasia (BPH). Thus, the identification of patients with chronic inflammation is mandatory for Urologists. This study investigates which clinical, imaging and laboratory findings are used by Urologists in clinical practice to diagnose BPH and chronic prostate inflammation.

Methods: This was a multicenter, non-interventional, observational study involving 30 Italian large-volume primary care urology centers. Patients were allocated into four diagnosis group: patients with BPH; patients with BPH and chronic prostate inflammation; patients with chronic prostate inflammation alone; and patients with lower urinary tract symptoms (LUTS) due to other causes.

Results: In total, 6134 patients were enrolled. BPH diagnosis with or without concomitant prostate inflammation was more frequent in older patients, while inflammation alone was prevalent in younger patients. Predictive factors for diagnosis of inflammation in all patients, regardless of age, were normal urinary flow (OR=2.73) and proved in-fection (OR=5.90), while in older patients (>61 years) diagnosis of chronic prostatic inflammation was specifically predicted by higher PSA values (≥4 ng/mL; OR=2.91), normal prostate volume (OR=10.23), mild symptoms (IPSS <8; OR=1.84), presence of intraprostatic calcifications (OR=4.55), and the combination of both infection and calcifications (OR=10.79).

Conclusions: In daily practice, the presence of chronic prostatic inflammation is underestimated. A stricter application of established diagnostic criteria suggested would increase the detection rate of chronic prostatic inflammation and potentially change the therapeutic approach in many patients with LUTS.
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http://dx.doi.org/10.23736/S0393-2249.17.02830-2DOI Listing
October 2017

The impact of previous prostate surgery on the outcomes of laparoscopic radical prostatectomy.

Minerva Urol Nefrol 2017 02 29;69(1):76-84. Epub 2016 Jun 29.

Urology Unit, Department of Neurosciences, Sciences of Reproduction and Odontostomatology, University of Naples "Federico II ", Naples, Italy.

Background: The aim of this study was to evaluate the outcomes in laparoscopic radical prostatectomy (LRP) in patients who had undergone prior prostate surgery (PPS).

Methods: In this study 946 consecutive LR P patients were included and a retrospective comparison between those patients who had received PPS (group A) and those who had not received PPS (group B) was carried out. The preoperative, intraoperative and postoperative data was collected in a prospectively-maintained database. All complications occurring ≤30 days after surgery were recorded and defined according to the Dindo-modification of the Clavien system.

Results: Longer operative time, greater blood loss, longer catheterization time, higher incidence of lymphocele, rectal injury and anastomotic stricture were found to be more frequent in group A. No statistically significant difference was noted between the two groups in terms of positive surgical margin rate and Biochemical recurrence free survival (BCRFS). Complete urinary continence rate resulted significantly higher in group B patients at both 1-year and 2-year follow-up. Potency rate resulted better in group B patients even if a statistically significant difference for both unilateral and bilateral nerve sparing techniques was not reached.

Conclusions: LRP procedure can be safely performed on patients who have previously undergone PPS without compromising oncologic safety whereas a negative impact on functional outcome in terms of achieving a complete urinary continence rate and sexual potency should be expected.
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http://dx.doi.org/10.23736/S0393-2249.16.02612-6DOI Listing
February 2017

Demographic and comorbidity profile of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a real-life clinical setting: Are 5-alpha-reductase inhibitor consumers different?

World J Urol 2015 May 10;33(5):685-9. Epub 2014 Dec 10.

Urologic Clinic, University Federico II of Naples, Naples, Italy.

Purpose: We aimed to describe, in a daily clinical practice setting, the demographic and comorbidity profile of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS), to compare the characteristics of patients receiving 5-alpha-reductase inhibitors (5-ARIs) with those not receiving them and to investigate predictors of 5-ARI prescription.

Methods: We performed a retrospective observational study using data retrieved from a general practitioners database. Male patients with diagnosis of BPH-LUTS were included. The following demographic and clinical data were available and extracted: age, comorbidities, BPH-LUTS medical therapy, drugs for comorbidities. A subgroup analysis was performed according to the use of 5-ARIs. Factors associated with 5-ARI prescription were assessed with uni- and multivariate analyses.

Results: A total of 7,103 patients were identified. Most patients (71.7%) were aged ≥65 years. Hypertension was present in 64.9% of patients; it was the most prevalent comorbidity followed by diabetes mellitus, hypercholesterolemia, coronary artery disease and other dyslipidemias. Overall, 38.22% of patients were treated with 5-ARIs. Mean age of patients taking 5-ARIs was significantly higher. The prevalence of hypertension and the use of antihypertensive drugs were significantly higher among patients receiving 5-ARIs. Older age was an independent predictor of 5-ARI prescription.

Conclusions: In a daily clinical practice setting, patients with BPH-LUTS receiving 5-ARIs are significantly older and have significantly higher prevalence of hypertension if compared with patients with BPH-LUTS not receiving 5-ARIs. Older age is an independent predictor of 5-ARI prescription.
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http://dx.doi.org/10.1007/s00345-014-1460-9DOI Listing
May 2015

Is there a place for nutritional supplements in the treatment of idiopathic male infertility?

Arch Ital Urol Androl 2014 Sep 30;86(3):164-70. Epub 2014 Sep 30.

Department of Urology, University of Federico II, Naples.

Objective: Infertility affects 15% of couples in fertile age. Male factor is a cause of infertility in almost half of cases, mainly due to oligoasthenoteratozoospermia (OAT). The purpose of this study is to review the effects of nutritional supplements as medical treatment for idiopathic male infertility.

Material And Methods: A Pub Med and Medline review of the published studies utilizing nutritional supplements for the treatment of male infertility has been performed.

Results: Clinical trials on Vitamin E, Vitamin A, Vitamin C. Arginine, Carnitine, N-Acetyl-Carnitine, Glutathione, Coenzyme Q10, Selenium and Zinc were reviewed. Although there is a wide variability in selected population, dose regimen and final outcomes, nutritional supplements both alone and in combination seems to be able to improve semen parameters (sperm count, sperm motility and morphology) and pregnancy rate in infertile men.

Conclusions: There are rising evidences from published randomized trials and systematic review suggesting that nutritional supplementation may improve semen parameters and the likelihood of pregnancy in men affected by OAT. This improvement, however, is not consistent and there is a wide variation in the treatment regimens used. Well designed and adequately powered RCTs are needed to better clarify the role of nutritional supplements as treatment for male infertility.
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http://dx.doi.org/10.4081/aiua.2014.3.164DOI Listing
September 2014

Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study.

Eur Urol 2014 Apr 22;65(4):733-9. Epub 2013 Aug 22.

Department of Urology, University of Naples Federico II, Naples, Italy.

Background: Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical development program.

Objective: To characterize the safety profile of dapoxetine in PE treatment and to report the incidence, severity, and type of adverse events.

Design, Setting, And Participants: We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10,028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30-60 mg (group A) and 3316 (32.4%) treated with alternative care/nondapoxetine (group B).

Interventions: Treatment with dapoxetine or alternative care/nondapoxetine.

Outcome Measurements And Statistical Analysis: Treatment-emergent adverse events (TEAEs) and concomitant therapy use during the 12-wk observational and the postobservational period were reported.

Results And Limitations: The mean age for all patients was 40.5 yr. In group A, 93.0% of the patients were initially prescribed dapoxetine 30 mg. Treatment options for group B patients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms, and behavioral counseling. Both treatment regimens were well tolerated. TEAEs were reported by 12.0% and 8.9% of group A and group B, respectively, with the highest incidence observed in patients aged >65 yr for group A (21.4%) and 30-39 yr (9.8%) for group B. The most commonly reported TEAEs were nausea, headache, and vertigo, with a higher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oral drugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A and one case in group B. A major limitation is that this was a nonrandomized, open-label, short-term study lacking efficacy data.

Conclusions: The results of this postmarketing observational study demonstrated that dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs. Syncope and major cardiovascular adverse events were not reported. The high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxetine minimizes the risk for its use in routine clinical practice. The current risk minimization measures for its identified and potential risks are effective.
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http://dx.doi.org/10.1016/j.eururo.2013.08.018DOI Listing
April 2014

Intraoperative and postoperative complications of laparoscopic pyeloplasty: a single surgical team experience with 236 cases.

J Endourol 2013 Oct 18;27(10):1224-9. Epub 2013 Sep 18.

1 Urology Unit, AORN Cardarelli Hospital , Naples, Italy .

Purpose: To describe and analyze a single surgical team's experience with intraoperative and postoperative complications arising from the Anderson-Hynes transperitoneal laparoscopic pyeloplasty (LP) procedure in the treatment of patients with ureteropelvic junction obstruction (UPJO).

Patients And Methods: There were 236 consecutive patients who underwent transperitoneal LP over a period of 8 years (2004-2012). These patients' records were retrospectively analyzed for intraoperative and postoperative complications. Of the 236 patients, 111 (47.0%) were males and 125 (53%) were females. In 226 patients, surgical indication was primary UPJO, and in 10 patients, recurrent obstruction. Two hundred and eleven patients (89.4%) were symptomatic.

Results: Mean operative time was 96.5 minutes (range 45-360 min). The mean blood loss was 20 mL (range 5-500 mL), and no blood transfusions were necessary. The overall success rate was 97% (229 patients) with a mean follow-up of 38 months (range 6-84 mos). In 86 of the 94 patients who presented with a crossing vessel (91.5%), the anomalous crossing vessel was transposed to the ureteropelvic junction (UPJ) dorsally because of evident obstruction. The mean postoperative hospital stay was 4.2 days (range 3-14 days). All 211 preoperative symptomatic patients reported a complete resolution of symptoms after the procedure. Intraoperative incidents occurred in nine (3.8%) patients, while postoperative complications occurred in 32 (13.5%) patients.

Conclusions: Our retrospective analysis confirms that LP is an efficacious and safe procedure resulting in a reported success rate of 97% and a concomitant low level of intraoperative (3.8%) and postoperative complications (13.6%). Major complications necessitating active management occur in a low percentage of cases (5.9% of patients). The most frequent and severe intraoperative complications are related to the Double-J stent insertion. The most common postoperative complication is urine leakage.
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http://dx.doi.org/10.1089/end.2013.0301DOI Listing
October 2013