Andrea, Ginepri

Antonella, Giannantoni

Carini, Marco

Cimino, Sebastiano

Eugenia, Fragala

Franco, Blefari

Giorgio Ivan Russo,

Giuseppe, Morgia

Giuseppe, Salvia

Giuseppe, Vespasiani

Marcello, Gentile

Minervini, Andrea

Rosalinda, Allegro

Rosaria Maria Pareo,

Salvatore, Arnone

Salvatore, Voce

Zaira, Collura

English

Florence Research

Vol. 191, No. 4S, Supplement, Monday, May 19, 2014 THE JOURNAL OF UROLOGY e669PD23-07SERENOA REPENS, LYCOPENE AND SELENIUM VS.TAMSULOSIN IN THE TREATMENT OF LUTS / BPH: AN ITALIANMULTICENTER RANDOMIZED COMPARATIVE STUDY BETWEENSINGLE OR COMBINATION THERAPIES. (PROCOMB STUDY)Giuseppe Morgia*, Giorgio Ivan Russo, Catania, Italy; Salvatore Voce,Ravenna, Italy; Marcello Gentile, Avellino, Italy; Antonella Giannantoni,Perugia, Italy; Franco Blefari, Prato, Italy; Marco Carini,Andrea Minervini, Firenze, Italy; Andrea Ginepri, Roma, Italy;Giuseppe Salvia, Acireale, Italy; Giuseppe Vespasiani, Roma, Italy;Cimino Sebastiano, Rosalinda Allegro, Zaira Collura, Eugenia Fragala,Catania, Italy; Salvatore Arnone, Ravenna, Italy; Rosaria Maria Pareo,Roma, ItalyINTRODUCTION AND OBJECTIVES: The following multi-center randomized protocol aimed to evaluate the efficacy and tolera-bility of the combination therapy between SeR, Ly and Se (Profluss ) +tamsulosin versus monotherapies with Ser, Ly and Se (Profluss ) ortamsulosin in patients with LUTS / BPH.METHODS: FromMarch 2011 to March 2012, 225 patients from11 Italian centers were enrolled in this randomized, double-blind study.The inclusioncriteriawere: agebetween55and80yearsold, absenceprostate cancer, PSA<4 ng/ml, IPSS12, prostate volume 60 cc, peakflow 15 ml/s, post -void residual (PVR)<150 ml. The participants wererandomized with a 1:1:1 ratio into 3 treatment arms each consisting of75 patients: group A (Profluss  1 tablet per day for 1 year), group B(tamsulosin 0.4 mg 1 tablet a day for 1 year) and group C ( Profluss  1tablet per day for 1 year + tamsulosin 0.4 mg 1 tablet per day for 1 year).RESULTS: Of all patients, 219 patients completed 12 months oftreatment. The treatment groups were statistically balanced. At theintergroup analysis, significant differences were found between group Cand group A in terms of IPSS (median change: -2, p<0.01), IPSS%(median change: -9.3, p<0.01), peak-flow (median change: 1, p¼ 0.04),peak-flow% (median change: 10.5, p¼ 0.02) and PVR (median change:-20.0, p¼0.001). We demonstrated a significant increase of at least 3points in the IPSS in 71.6 % of subjects in group C when compared togroup A ( 53.7 %, p¼ 0.01) and group B (51.3 %, p¼ 0.04), a significantdecrease of 25%of the IPSS in 44.6%of patients in groupC compared togroup A ( 23.9 %, p ¼ 0.004) and group B (23.1 %, p ¼ 0.002) anda significant increase of 30 % of peak-flow in 47.30 % of patients ofGroup C compared to group A (29.85%, p¼0.03) and group B (30.77%,p¼0.03). Significant differences were found in terms of IPSS (medianchange: -2.0, p¼ 0.002), IPSS% (median change: -9.0, p¼0.008), peak-flow (median change: 0.8, p¼0.04) and peak-flow% (median change:6.4, p¼0.02) between group C and group B.No difference between the two groups in terms of PVR (p¼0.23).CONCLUSIONS: In this multicenter, randomized, double-blindstudy the combination therapy with Ser-Se-Ly + tamsulosin 0.4 mg for 1year was demonstrated to be more effective than the individual mono-therapies in terms of reduction of the symptom score (IPSS) and interms of increasing the Qmax in patients suffering from LUTS / BPH ofmoderate to severeSource of Funding: nonePD23-08COMBINATION OF TAMSULIN (0.4 MG) AND DUTASTERIDE (5 MG)FOR BENIGN PROSTATIC HYPERPLASIA. OBJECTIVE ANALYSISOF STROMAL COMPONENTS OF THE TRANSITION ZONEAndre Cavalcanti*, Felipe Restrepo, Waldemar Costa, Carla Gallo,Bruna Pereira, Nathalia Machado, Francisco Sampaio, Rio de Janeiro,BrazilINTRODUCTION AND OBJECTIVES: We conducted anobjective (stereological) histological analysis of the stromal componentsof the transition zone of benign prostatic hyperplasia (BPH) patientsusing or not using a combination of tamsulin (0.4-mg) and dutasteride(5-mg).METHODS: BPH samples were analyzed in the transition zoneof 5 patients submitted to open surgery without previous treatment(control group) and 5 patients with BPH, submitted to open surgery,which underwent treatment with tamsulosin + dutasteride for 3 monthsprior to surgery.The samples were removed after open surgery, and fixed in 4%buffered formalin for a maximum period of 24 hours. Fragments fromthe 2 groups were subjected to the following histochemical techniques;hematoxylin-eosin, Masson’s trichrome and Picrosirius red for anal-ysis of connective tissue, and immunohistochemical staining by usingthe anti-alpha-actin for the analysis of smooth muscle fibers and anti-elastin for analysis elastic system. Quantitative analysis was per-formed using Image J software with the differentiation method of colorsegmentation.RESULTS: The analysis of sections stained by Picrosiriusobserved under polarized light showed no difference in collagenarrangement and distribution between treated and untreated patients.Both groups presented reddish homogeneous fibers in all analyzedfields, characterizing the presence of thicker fibers, possibly collagentype I. In the sections stained by Masson’s trichrome, the quantitativeanalysis showed a significant decrease of approximately 34% of thecollagen in individuals that used combo dart, when compared to con-trols. The immunohistochemical analysis showed an increase of 42% inthe elastic system fibers in patients using combodart, when comparedto controls. Regarding smooth muscle fibers, the patients in combodartgroup presented an increase of 81%.CONCLUSIONS: Although these results are preliminary, with asmall number of patients, to our knowledge, this is the first report of acomparative objective of BPH stromal components of controls andpatients using combodart. The study would continue increasing thenumber of patients and an analysis of other components of the stromaand parenchyma.Source of Funding: Supported by grants from the Coordinationfor Improvement of Graduated Students (CAPES), NationalCouncil of Scientific and Technological Development (CNPq),and Foundation for Research Support of Rio de Janeiro(FAPERJ), Brazil.PD23-09ALFUZOSIN AND FLUBRIPROFEN COMBINATION THERAPY FORTHE MANAGEMENT OF LOWER URINARY TRACT SYMPTOMSCevdet Serkan Gokkaya*, Binhan Kagan Aktas, Cuneyt Ozden,Suleyman Bulut, Mehmet Karabakan, Akif Ersoy Erkmen, Ankara,Turkey; Ali Memis, Kars, TurkeyINTRODUCTION AND OBJECTIVES: To compare the efficacyand safety of alfuzosin alone, flurbiprofen alone, and alfuzosin plusflurbiprofen combination for lower urinary tract symptoms (LUTS)caused by benign prostatic obstruction (BPO).METHODS: Seventy-eight patients complaining of LUTS sec-ondary to BPO were enrolled in this clinical trial. Patients without anycardiac or hepatorenal insuffenciency and without peptic ulcus historywere randomly assigned to receive alfuzosin XL 10 mg, flurbiprofen SR200mg or combination treatment. Trans-rectal ultrasound was per-formed for measurement of prostatic volume firstly, then patients wereevaluated by using International Prostate Symptom Score (IPSS)(irritative, obstructive and total separately), uroflowmetry (maximal andaverage urinary flow rate (Qmax and Qave)) and both at baseline andfollowing a 4-week treatment course.RESULTS: There was not any difference among the groupsregarding age and baseline values of prostate volume, irritative,obstructive and total IPSS, Qmax, Qave and residue (P>.05). The total,irritative and obstructive IPSS and residue decreased significantly in all3 groups after treatment (P <.01). Qmax and Qave significantlyimproved only in combination therapy group (P <.01) without anyadditional significant side effect.CONCLUSIONS: A combination of an alpha blocker alfuzosinwith flurbiprofen which is a member of the phenylalkanoic acid

SERENOA REPENS, LYCOPENE AND SELENIUM VS.

TAMSULOSIN IN THE TREATMENT OF LUTS / BPH: AN ITALIAN

MULTICENTER RANDOMIZED COMPARATIVE STUDY BETWEEN

SINGLE OR COMBINATION THERAPIES. (PROCOMB STUDY)

https://flore.unifi.it/bitstream/2158/1056780/1/PD23-07.pdf

SERENOA REPENS, LYCOPENE AND SELENIUM VS. TAMSULOSIN IN THE TREATMENT OF LUTS / BPH: AN ITALIAN MULTICENTER RANDOMIZED COMPARATIVE STUDY BETWEEN SINGLE OR COMBINATION THERAPIES. (PROCOMB STUDY)

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