Issues n.2 - 2012

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n.2 - 2012

Hot topics in urological health economics. A mini review

Marco Racioppi, Giuseppe Palermo, Alessandro D’Addessi, Francesco Pinto, Emilio Sacco, Daniele D’Agostino, Matteo Vittori, Pier Francesco Bassi

Clinica Urologica, Università Cattolica del Sacro Cuore, Roma, Italy

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Summary
 

Urological diseases are becoming a major public health problem. In fact, they increasingly weigh on the economy of a country due to the high direct costs and the consequent significant loss of productivity. Prostate cancer represents 11% of the costs for the treatment of all cancers in the United States with $ 8 billion and a cost per-patient from diagnosis to death of $ 81658. Instead bladder cancer has the higher costs per-patient in terms of medical care, from diagnosis until death (U.S. $ 96,553). In Italy, in a reference hospital, the average costs of non muscle-invasive forms treated with endoscopic resection (TURB) and infiltrating forms treated with radical cystectomy are approximately € 2,242.20 and € 6860 respectively, but they increase due to the follow-up and the ancillary treatments. In the field of functional disease, in the U.S. the average annual expenditure per capita for incontinence, including inpatient and outpatient services is $ 1,382. While for patients who had undergone surgery the average total spending rose to $ 3,620. For overactive bladder the total cost in the United States is estimated at 12.02 billion U.S. dollars, with $ 9.17 billion allocated to the community costs and $ 2.85 billion for institutional costs. However, further pharmacoeconomic studies are required to better understand the net economic impact of any alternative strategies to those actually present. Stone disease is a highly prevalent and costly condition for which United States total health care expenditures, in the 2000 year, were estimated to be almost $ 2.1 billion. Treatment of nephrolithiasis depends on stone size and location, but typically involves a surgical procedure such as extracorporeal shock wave lithotripsy (ESWL), ureteroscopic laser lithotripsy, percutaneous nephrostolithotomy (PCNL) or open stone surgery with an average expenditure per procedure of $ 2.295, $ 1.425, $ 3.624, $ 2,916 respectively.


Comparıson of tumor grade and stage with nuclear factor kappa b and p38 mitogene activated protein kinase expressions in renal cell cancer

 Emin Ozbek 1, Tamer Aliskan 1, Alper Otunctemur 1, Gokhan Calik 1, Suleyman Cakir 1, Murat Dursun 1, Adnan Somay 2

1 Okmeydani Training and Research Hospital, 1st Urology Clinic, Istanbul, Turkey

2 Fatih Sultan Mehmet Training and Research Hospital, Pathology Clinic, Istanbul, Turkey

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Summary

Objectives: Renal cancer is common among urinary system cancers. Most common one is clear cell carcinoma and it makes up 60-70% of renal cell carcinomas. Invasion pathophysiology and molecular mechanisms that take part are crucial for the diagnosis, treatment and prognosis of this disease. In this study, nuclear factor kappa B(NFKB/p65) and p38 mitogene activated protein kinase, which play an important role in signal transduction system of clear cell renal carcinoma, are assessed.

Materials and methods: We considered 40 patients who had radical nephrectomy or partial nephrectomy for renal tumor in Okmeydani Training and Research Hospital 1st Urology Clinic. Normal tissue samples of these patients were used as control group. Paraffin embedded samples of renal cancer were studied with immunohistochemistry using spesific monoclonal and polyclonal antibodies of NFKB and MAPK. Expression density was compared with tumor grade and diameter, semiquantitively. Results were assessed with Spearman correlation and Pearson chi-square tests.

Results: There were 28 (70%) males and 12 (30%) females in our study. Age range of patients was between 19 and 80 years, and mean age was 59,3 ± 13,4. NFKB and p38MAPK expressions were higher in cancer specimens compared with control group (p < 0,05). Tumor diameter and grade increase were directly correlated with p65(NFKB) and p38MAPK expression (p < 0.05).

Conclusions: MAPK and NFKB expression is related to tumor grade and stage. Also more studies are needed to define the relationship with lymph node metastasis, organ metastasis and survival rates.
 

Effects of the association of potassium citrate and Agropyrum repens in renal stone treatment: Results of a prospective randomized comparison with potassium citrate

Simone Brardi, Patrizio Imperiali, Gabriele Cevenini, Tiziano Verdacchi

Hemodialysis Unit, Ospedale S. Donato, Arezzo, Italy

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Summary

Objectives: To evaluate by a prospective randomized controlled study the efficacy of the association of potassium citrate and dry extract of wheatgrass (Agropyrum repens) (CALCOMEV ®) in renal stone treatment.

Materials and Methods: 50 patients with nephrolithiasis associated with one or more active metabolic alterations that constitute an indication to the use of potassium citrate were randomly divided in two equal unblinded treatment groups. A group of patients was assigned to treatment with the association of potassium citrate and wheatgrass (at the dose of 24 mEq of potassium citrate and 100 mg of dry extract of Agropyrum repens bis in die) and the other group to potassium citrate (at a dose of 20 mEq ter in die). Each form of main treatment was associated, depending on the results of metabolic basal assessment, to allopurinol and/or an association of amiloride and hydrochlorothiazide and/or pyridoxine. Patients of both groups were advised the same diet based on a reduced intake of sodium, foods rich in oxalate and protein of animal origin, a normalized intake of calcium and an increase in fluid intake (> 2 liters day).

Results: At the end of the 5-month follow-up period, the group treated with the association of potassium citrate and wheatgrass showed a significant reduction in the total number of stones (-1.0 ± 0.2 vs 0.0 ± 0.2 stones) and in the larger diameter of the stones (-3.6 ± 0.9 mm vs 0.0 ± 0.8 mm), as well as a statistically significant reduction of uric acid urinary excretion (-164.7 ± 45.3 vs -38 ± 42 mg/24 h). No significant differences in the two groups were observed with respect to urinary citrate, oxalate and calcium urinary excretions and urinary pH.
Conclusions: This prospective randomized study demonstrates the superiority of the association of potassium citrate and dry extract of wheatgrass, in combination with standard pharmacological and dietary treatment, in reducing the number and size of urinary stones with respect to potassium citrate in association with the same pharmacological and dietary regimen.

 

Has the cost of anti-muscarinic a key role in the success rate of patients diagnosed with overactive bladder syndrome?

Carlo Vecchioli Scaldazza, Carolina Morosetti, Gianna Pace, Berouz Azizi, Willy Giannubilo, Vincenzo Ferrara

Department of Urology, Hospital of Jesi, Jesi, Italy

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Summary

Introduction: Overactive Bladder Syndrome (OAB) is a chronic disease, the prevalence in the general population is reported to be 14-16%. Anti-muscarinic agents are considered the first-line pharmacological treatment for the management of OAB; although a long lasting therapy is indicated to reach a better control of OAB symptoms an high percentage of patients discontinue the cure after a brief period. Our attempt is to investigate whether the cost of solifenacin succinate may influence the long lasting regimen and patients' drug efficacy.

Materials and Methods: 70 consecutive women, with symptoms of OAB were enrolled in this randomized controlled study. In group A, all patients received solifenacin 5 mg by the urologist, without any cost; they were instructed to get the drug once daily for 4 months, differently, in group B, patients need to buy the drug which was administered as in the group A. Urgency, frequency, nocturia, incontinence, voided volume, were evaluated by a 3-day micturition diary. Overactive Bladder Questionnaire Short Form (OAB-qSF) was used to assess the impact of OAB symptoms on patients’ quality of life (QoL). Urgency was assessed by patient’s perception of intensity of urgency scale (PPIUS). Micturition-diary, OAB-qSF, PPIUS, were completed at baseline and after four months.

Results: A greater number of patients discontinued solifenacin in the group B who need to buy the drug. We observed significant differences in group A and B in relation to frequency, nocturia, urge incontinence and voided volume comparing the pre and post treatment symptoms scores. The patients’ perceptions of intensity of urgency and the PGI-I scale showed a significant improvement greater in group A in respect with group B.

Conclusions: The cost of anticholinergic may be responsible for both early discontinuation of treatment and incomplete adherence to therapy with unsatisfactory results on symptoms and an incorrect assessment of the effectiveness of the drug by the urologist.


Awareness of the role of the pelvic floor muscles in controlling the ejaculatory reflex: Preliminary results

Giuseppe La Pera

Dept. of Urology, San Camillo - Forlanini Hospital, Rome, Italy

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Summary

The difficulty in correctly identifying the etiologic factors of premature ejaculation (PE) could be due to the fact that the role of the pelvic floor muscles (PFMs) in the voluntary control of ejaculatory reflex has not been elucidated.

The aim of the present investigation was to measure the prevalence of awareness of the role and use of PFM contraction in controlling the ejaculatory reflex among PE and non-PE participants.

A total of 44 men with PE and 73 men without PE were recruited. In the first part of the study, we validated a test that rendered the participants aware of the PFMs through digital rectal examination and the PFM contraction. In the second part, we posed this multiple-choice question: “Which muscles do you use to delay ejaculation?” Men not answering correctly were considered not to be using the PFMs and also to be unaware that it is necessary to contract the PFMs to control the ejaculatory reflex. Only 3 of 44 subjects (6.8%) with PE and 60 of 73 subjects (82%) without PE answered correctly and used PFMs to control the ejaculatory reflex (Fisher test p < 0.0001). This test has a sensibility of 93%, a specificity of 82%, and an accuracy of 86%.

The vast majority of PE subjects were unaware that to inhibit or delay ejaculation it is necessary to contract the PFMs. This association also raises the question whether the difficulties in defining PE and finding effective PE therapies could be due to a nonhomogeneous population of PE patients with different etiopathogenetic factors. More studies are required to confirm these data and to answer this question.


(Micro)surgical and percutaneous procedures in the management of varicocele: 25 years of experience

Gianni Ughi, Lucio Dell’Atti, Consuelo Ricci, Giovanni Pietro Daniele

Urology Unit, Arcispedale "S. Anna", Ferrara, Italy

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Summary 

Background: The effectiveness of different procedures for varicocele varies in terms of recurrence, sperm-count improvement, pregnancies and deliveries.

Objectives: To determine if microsurgical varicocelectomy plus antegrade sclerotherapy under local anaesthesia is the first choice surgical modality to treat this disease.

Methods: Since 1983 out of more than 1000 patients treated for primitive varicocele, we considered 800 patients with a follow-up of two years. Out of them 195 underwent a “standard” surgical procedure, 280 received a percutaneous sclerotherapy and 325 were managed microsurgically. Out of the last group, the first 90 cases were operated by microsurgical technique alone, while the remaining were offered microsurgery plus antegrade sclerotherapy.

Results: Traditional surgery had the higher incidence of relapse whereas percutaneous sclerotherapy needed use of Gianturco’s coil to minimize relapses. Microsurgical technique plus antegrade sclerotherapy had the lower incidence of failures.

Conclusions: An extensive experience through the years led us to consider microsurgery plus sclerotherapy as the first choice treatment for varicocele.


Corporoplasty for induratio penis plastica with soft axial tutors, single relaxing albugineal incision and safenous grafting. A 3-year follow up

Mauro Silvani, Stefano Pecoraro, Alessandro Zucchi

Department of Urology ASLBI Hospitals Infermi, Biella, Italy

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Summary 

Objectives: Etiological and pathogenic mechanisms of Peyronie’s disease (PPI) are today better known than in the past, but till now therapeutic options are not completely satisfactory. In fact several therapeutic alternatives were suggested, but none demonstrated its superiority. Surgery is the preferred option in chronic stable disease with the following goals: penile straightening, penile lengthening and recovery of penetrative coital activity. Aim of this paper was to present a personal experience with modifications of the original surgical technique.

Materials and Methods: From September 2005 to December 2008, a total of 58 patients (mean age 44.7 years) underwent corrective penile surgery for PPI. All patients had a single plaque with dimensions ranging 1.2-2.6 cm in length. Simple dorsal recurvatum > 50° was observed in 38 patients, dorsolateral left recurvatum > 45° in 8, ventral recurvatum > 40° in 6, lateral left recurvatum > 45° in 4, dorsolateral right recurvatum > 45° in 2. Forty patients were implanted with a 7 F Virilis II prosthesis, 7 with a 7 F Virilis I, 8 with 10 F Virilis I and 3 with 9.5 F SSDA prosthesis. Implanted tutor length ranged between 16.6 and 20 cm, measuring from crura to corpora apex. In 46 patients we implanted a safena graft and in 12 with recurvatum > 60° we used bovine pericardial collagen patch (Veritas - Hydrix).

Results: At long term follow up (1-3 years) we observed a penile elongation from 1.2 to 2.3 cm with complete correction of penile recurvatum in all the patients. After 12-36 months excellent penetrative sexual activity was referred by 75% of the patients, satisfactory in 20% and disappointing in 5%. Major complaints were “cool glans” feeling, delayed ejaculation, unnatural penis appearance due to permanent hyperextension. None developed lower urinary tract symptoms.

Conclusions: According to such results, the described technique should be considered as a gold standard for all cases of PPI associated to recurvatum > 35-40° (lateral, ventral and dorsal) associated to a plaque with mild-moderate erectile dysfunction.
 

A prospective observational cohort study on patients with PSA levels ranging from 4 to 10 ng/ml at opportunistic screening: Management and responses to ciprofloxacin 1000 mg

Paolo Verze, Fabio Parazzini, Davide Arcaniolo, Sonia Cipriani, Vincenzo Mirone

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

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Summary 

Objective: To analyze in the real life clinical setting the effect of fluorchinolones treatment in the management of elevated (4-10 ng/ml) prostate-specific antigen level we conducted an observational prospective cohort study.

Material and methods: Eligible for the study were subjects aged 45-75 years with a PSA level 4-10 ng/ml, consecutively observed during their routine practice by first level outpatients urologic centres.

Results: A total of 740 patients, mean value of total PSA at study entry: 5.8 (SD = 1.6)) entered the study. A total of 616 subjects were treated with ciprofloxacin. The mean serum t-PSA value decreased between study entry and final visit of 1.31 ng/ml (SD 4.19) (p < 0.05). At follow up visit the 49.4% (95% CI 44.1-55.5) of patients had PSA level < 4 ng/ml. in comparison with patients with t-PSA < = 5.0 ng/ml, the OR of having normal t-PSA value at follow up were respectively 0.61 (95%CI 0.4-0.9) and 0.23 (0.1-0.3) for patients with t-PSA 5.1-6.2 and ≥ 6.3, in comparison with those with t-PSA < = 5.0.

Conclusion: The results of this large observational prospective study showed that a 2-3 week course of treatment with ciprofloxacin 1000 mg is able to significantly reduce the PSA level in about 50% of men aged 45-75 years with t-PSA levels of 4-10 ng/ml.


Multicentre study on the efficacy and tolerability of an extract of Serenoa repens in patients with chronic benign prostate conditions associated with inflammation

Roberto Giulianelli, Stefano Pecoraro, Giuseppe Sepe, Rosario Leonardi, Barbara Cristina Gentile, Luca Albanesi, Stefano Brunori, Luca Mavilla, Francesco Pisanti, Renato Giannella, Patrizia Morello, Domenico Tuzzolo, Mario Coscione, Fabio Galasso, Tammaro D'Angelo, Paolo Ferravante, Emilio Morelli, Antonio Miragliuolo, and Cooperative Ur.O.P. group

Villa Tiberia Clinic, Urology Department, Rome, Italy

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Summary 

Introduction: Chronic benign prostate diseases are very common and certainly feature significantly in urological practice.The treatment of chronic benign prostate diseases is a common problem in clinical practice: few studies have been conducted in routine clinical practice to evaluate the efficacy of the treatments for this clinical condition. The objective of this study was to evaluate the efficacy of an extract of Serenoa repens (Permixon®) in the treatment of lower urinary tract symptoms (LUTS) in patients with chronic benign prostate diseases with associated inflammation, also taking into consideration the influence of treatment on sexual function and, therefore, on patients’ quality of life.

Materials and Methods: All the 591 eligible subjects were evaluated on entering the study; after a screening visit, including medical history, physical examination, physical examination and digital rectal examination (DRE) and laboratory tests, the patients underwent uroflowmetry. The subjects under investigation were also asked to complete the IPSS, NIH-CPSI and IIEF-5 questionnaires, for the purpose of evaluating urinary symptoms and erectile function in relation to sexual activity in the previous 6 months.

Results: The analysis of the uroflowmetry results showed that treatment with extract of Serenoa repens (Permixon®) distinctly improves bladder voiding and lower urinary tract symptoms, as highlighted also by the improvement in the scores for the IPSS and NIH-CPSI questionnaires which serve as a basis for evaluating the urinary symptoms of patients with prostatic hyperplasia and chronic prostatitis respectively. The results also suggest that using an extract of Serenoa repens (Permixon®) for 6 months in patients with chronic benign prostate diseases gives rise to an improvement in erectile function, as demonstrated by the increase in the scores for the IIEF-5 questionnaire after 6 months of treatment.

Conclusions: The results of this study demonstrate how treatment for 6 months with an extract of Serenoa repens (Permixon®) in routine clinical practice gives rise to a statistically significant improvement in Qmax values and in the IPSS, NHI-CPSI and IIEF-5 questionnaire scores, resulting not only in an improvement in urinary symptoms but also in an overall improvement in patients’ quality of life.
 

Clinical importance of the micro-focal prostate cancer on a single sample of a Trans-Rectal 8core biopsy

Giandomenico Passavanti, Michele Gnech

U.O. Urologia - Ospedale Misericordia, Grosseto, Italy

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Summary

Objective: We tried to verify retrospectively, the clinical importance of a single microfocal prostate cancer at biopsy (as microscopic aspect of a group of 12 neoplastic glands 40x) in patients subsequently treated with radical prostatectomy (RP).

Materials and Methods: from January 2008 to November 2010 we carried out 760 eight-core prostate biopsies for increased PSA in patients with a prostatic volume of </= 40cc.

A total of 252 patients (33.15%) had a prostate cancer and out of them 17 (6.7%) had a microscopic prostate cancer -16 a single microscopic focus and a case 2 microscopic foci in two different specimens. PSA ranged 5 to 7.4 ng/ml (mean 6.2 ng/ml), age ranged 61 to 75 (mean 68.29), Gleason score was G6 in all cases; in 4 cases a microscopic focus of PIN3 was associated.

Results: All patients had a RP and the pathologic stage was 4 T2a in 4, T2b in 1, T2c in 9 (3 of these had microscopic PIN3 at biopsy) and T3a in 3 (including the one with 2 microscopic foci of prostate cancer on 2 different bioptic samples). Gleason was G6 in 12 cases and G7 in 5.

Discussion: The single microscopic focus of prostate cancer has always raised diagnostic problems, in fact some authors report these patients have 30 to 90% of probability to have a significant prostatic cancer (volume > 0,5 ml) whereas other authors found an insignificant prostatic cancer in 30% of the patients with a single microscopic focus of prostate cancer. It is really very difficult to predict the extent of the tumor in these cases because the different parameters employed are not reliable.

Our series, although very small, support the hypothesis that significant cancers are more frequently associated with a single microscopic focus of prostate cancer at biopsy (in fact 17 out of 17 patients had a significant cancer) and consequently we feel that it is more oncologically correct to choose an aggressive therapy in these cases (RP, radiotherapy or androgen deprivation according to the individual case) rather then a “wait and see” which could be less cautious.


Partial priapism secondary to idiophatic segmental thrombosis of corpora cavernosa

Pietro Pepe 1, Paolo Panella 1, Giuseppe Candiano 1, Antonio Garufi 2, Giandomenico Priolo 2, Francesco Aragona 1

1 Urology Unit - Cannizzaro Hospital, Catania, Italy

2 Imaging Department - Cannizzaro Hospital, Catania, Italy.

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Summary
 

A 51-year-old man presented at our Department 2 days after the onset of a painful mass in the perineum and dysuria. Diagnosis of partial priapism secondary to proximal segmental corpora cavernosa thrombosis was made through colordoppler ultrasound (CDU) and magnetic resonance imaging (MRI). Treatment consisted of administration of systemic anticoagulation drugs (acenocumarol) and local injection of ethylephrine chloridrate. The thrombosis resolved after two months with incomplete restoration of erectile function (loss of rigidity). In conclusion, on the basis of previous reports (23 cases reported in literature) and our experience, in presence of painful mass in the perineum, CDU and MRI evaluation allows to make diagnosis of the rare proximal partial priapism that as first option should be treated conservatively.