Compliance to therapy with Dapoxetine in comparison to a conventional selective serotonin reuptake inhibitor (Citalopram) in 118 patients with premature ejaculation.

Premature Ejaculation (PE) is a sexual dysfunction that concern 20-30% of the male population. Dapoxetine is a new serotonine re-uptake inhibitor (SSRI)specific for PE treatment.Aim of the study is to assess compliance and effectiveness of the treatment with dapoxetine compared to the treatment with citalopram (a classic SSRI used to treat PE)

Risultati di uno studio randomizzato singolo cieco placebo versus Diallil-Tiosulfinato, Nuciferina e Diosgenina in pazienti responders a Tadalafil 5 mg; Results of a single blind study placebo vs Diallil-Tiosulphinate, Nucipherine and Diosgenin in patients reponders to Tadalafil 5 mg

The aim of the study is to evaluate the efficacy of Diallil-Tiosulphinate, Nuciepherine and Diosgenin in the treatment of erectile dysfunction. In our study were selected 120 men affected by erectile dysfunction. They were filled in a self-administered questionnaire International Index of Sexual Medicine. 74 of them reported a moderate erectile dysfunction and 46 reported a severe ED. All patients were treated with Tadalafil 5 mg once a day for 90 days. They were re-evaluated with the same questionnaire after three months of therapy. In 75% of the patients there was an improvement of IIEF-5 score. Only the 90 patients responders to Tadalafil once a day were randomized and divided into two groups, each formed by 45 subjects. The group A was treated with the association of Diallil-Tiosulfinate, Nucipherine and Diosgenin on alternate days. The patients of group B were treated with placebo. After three months, there was a new evaluation with IIEF-5 score. In group A we reported a maintenance of improvement post-Tadalafil in 36 patients;in group B, only 18 patients have maintained the previous improvement, according to IIEF-5 score. The χ2 test is 13,38, with a p-value of about 0,00013.The maintenance’s odds ratio, confronting the two groups, is 6 with a confidence’s interval of 95%. The study shows that the utilization of the association therapy in patients with erectile dysfunction responders to Tadalafil once a day is able to duplicate the odds of maintenance’s improvement compared to placebo

Effetti sulla disfunzione erettile dell'associazione di dialliltiosulfinato, nuciferina e diosgenina in pazienti pretrattati con inibitori della 5 fosfodiesterasi once a day. Studio randomizzato versus placebo singolo cieco.

SCOPO DEL LAVORO Dimostrare l’efficacia del prodotto di associazione, a base di diallil-tiosulfinato, nuciferina e diosgenina, in soggetti affetti da disfunzione erettile nel mantenimento della risposta positiva, in termini di miglioramento dello score dell’International Index of Sexual Medicine (IIEF-5), dopo periodo di terapia con tadalafil 5mg giornaliero per tre mesi. MATERIALI E METODI Sono stati selezionati 120 pazienti affetti da Disfunzione Erettile moderata e severa secondo lo score del questionario IIEF-5 di età compresa tra 50 e 65 anni (età media di 56,7) e sottoposti a terapia giornaliera con Tadalafil 5mg: una compressa per tre mesi. Al termine del trimestre i pazienti sono stati rivalutati mediante nuova compilazione del questionario IIEF-5. I 90 pazienti risultati responders alla terapia sono stati campionati per randomizzazione semplice (criterio della estrazione) e suddivisi equamente in due gruppi omogenei. I non responders (30 pazienti) sono stati avviati ad altra terapia. Il gruppo A dei responders è stato trattato con l’associazione di Diallil-Tiosulfinato 20 mg, Nuciferina 137,5 mg, Diosgenina 45mg: una compressa a giorni alterni per tre mesi. Ai pazienti responders del gruppo B veniva somministrato placebo. Entrambi i gruppi sono stati sottoposti a follow-up per tre mesi. Al termine del follow-up è stata consegnata ulteriore copia del questionario IIEF-5. RISULTATI Nel gruppo A si è avuto un mantenimento della risposta positiva nell’80% dei casi (36 pazienti) con una stabilizzazione del deficit erettile nella categoria lieve-moderata secondo lo score dell'IIEF-5. Nel gruppo B, invece, è stato riscontrato un peggioramento nel 60% dei casi (27 pazienti), con uno score sovrapponibile al periodo di reclutamento pre-Tadalafil. Il test delX2 che ha messo a confronto la proporzione dei risultati tra i due gruppi, ha dato esito a 15,000 con una p=0,0001. La misura dell’associazione determina un rischio relativo pari a 2 (i.c. 1,36-2,94). DISCUSSIONE L’impiego della terapia associativa con Diallil-Tiosulfinato, Nuciferina e Diosgenina nella disfunzione erettile si è dimostrato capace di raddoppiare la probabilità di mantenere il paziente affetto da deficit erettile nella categoria di score IIEF-5 raggiunta in precedenza, in confronto alla stessa popolazione trattata con solo placebo, dopo terapia con tadalafil. CONCLUSIONI L’associazione dei tre principi attivi nella disfunzione erettile rappresenta un valido supporto nel follow-up del paziente trattato con Tadalafil once a day garantendogli nel tempo il mantenimento della performance sessuale

Cytokines gene expression in the tunica albuginea in patients with Peyronie’s disease. Pilot study with a control group

INTRODUCTION: We decided to conduct a study to investigate the presence of cytokines in the albuginea of subjects with Peyronie's disease (PD). Cytokines, as responsible for intercellular communication, maybe involved in the pathogenesis of the disease. The identification of one or more involved cytokines may, in fact, be useful in the pharmacological treatment with biologic drugs that are able to interfere with specific cytokines. MATERIALS AND METHODS: Between January 2009 and Decembre 2010 at the Clinic of Urological outpatients clinic of the Policlinico of Palermo were recruited 20 subjects with PD, mean age 62.3 years (range 51-70) and 8 subjects with congenital recurvatum penis (mean age 21.5; range 19-28), the latter used as a control group. Inclusion criteria were the criteria for operability with Nesbit corporoplasty. The albuginea specimens were used to test gene expression of pro-fibrotic and pro-inflammatory, using Real-Time PCR. They were also subjected to histological examination after fixation by staining with hematoxylin-eosin (H&E). RESULTS: Histological examination performed on samples from both groups demonstrated the absence of inflammatory cells in all patients reviewed for the study. The analysis of the expression of genes encoding IL-4 (Interleukin-4), IL-6 (Interleukin-6), IL-13 (Interleukin-13), TGF-β (Transforming Growth Factor-β1), IL-2 (Interleukin-2), IL-10 (Interleukin-10), TNF-α (Tumor Necrosis Factor-α) and IFN-γ (Interferon-γ) showed a very low level of transcripts in all samples (in some cases undetectable). The levels of cytokine transcripts examined were lower in samples from patients with PD compared with controls. CONCLUSIONS: From the results obtained, the use of biologic drugs (antibodies) againsta the cytokine does not seem to be useful in the stable phase of Peyronie's disease due to the very low concentrations of cytokines found in the tunica albuginea of the patients

Cytokine gene expression in the tunica albuginea in patients with Peyronie's disease. Pilot study with a control group

INTRODUZIONE: Abbiamo pensato di effettuare uno studio che indagasse circa la presenza delle citochine nell’albuginea di soggetti affetti da malattia di La Peyronie. Le citochine, in quanto responsabili della comunicazione intercellulare, potrebbero essere coinvolte nella patogenesi della malattia. L’individuazione di una o più citochine responsabili potrebbe, infatti, risultare utile nel trattamento farmacologico grazie ai c.d. farmaci biologici, in grado di interferire con le citochine. MATERIALI E METODI: Per lo studio sono stati reclutati tra gennaio 2009 e dicembre 2010 presso l’Ambulatorio di Chirurgia Andrologica del Policlinico di Palermo 20 soggetti affetti da malattia di La Peyronie (fig. 1) e 8 soggetti affetti da recurvatum penis congenito, questi ultimi adoperati come controllo. Come criteri di inclusione allo studio abbiamo considerato i criteri di operabilità con corporoplastica secondo Nesbit. I prelievi bioptici ottenuti dalle losanghe escisse in corso di intervento chirurgico sono stati utilizzati per saggiare l’espressione genica, attraverso Real-Time PCR, di citochine pro-fibrotiche e pro-infiammatorie. Inoltre sono stati sottoposti dopo fissazione ad esame istologico con la colorazione ematossilina-eosina. RISULTATI E DISCUSSIONE: L’esame istologico ha rilevato l’assenza di cellule infiammatorie in tutti i pazienti recensiti per lo studio. L’analisi dell’espressione dei geni codificanti per IL-4 (Interleuchina-4), IL-6 (Interleuchina-6), IL-13 (Interleuchina-13), TGF-β1 (Trasforming Growth Factor - β1), IL-2 (Interleuchina-2), IL-10 (Interleuchina-10), TNF-α (Tumor Necrosis Factor- α) e IFN-γ (Interferone- γ) ha evidenziato in tutti i campioni un livello molto basso di trascritti e in alcuni casi indosabili (fig. 2). Inoltre i livelli dei trascritti delle citochine prese in esame sono risultati minori nei campioni provenienti dagli individui affetti da malattia di La Peyronie rispetto ai controlli. CONCLUSIONI: Alla luce dei risultati ottenuti, l’utilizzo di farmaci biologici (anticorpi) contro le citochine non sembra essere applicabile nella fase stabile della malattia di La Peyroni

La circoncisione nella corporoplastica secondo Nesbit: tempo obbligatorio? Esperienza su 158 pazienti (Circumcision in Nesbit corporoplasty: a mandatory time? Our experience on 158 patients)

INTRODUCTION: The Nesbit procedure is the most common surgical technique to correct congenital or acquired penile curvature. It is a common opinion that this surgical procedure has to be completed with a circumcision to prevent foreskin necrosis or phimosis. According to our experience we believe that some procedural "tricks" could strongly reduce that mechanical and ischemic trauma on the foreskin responsible for these complications. MATERIALS AND METHODS: From 1988 to 2010 we selected 158 patients treated with Nesbit's corporoplasty. The procedure was recommended to patients who presented a penile curvature wider than 30° and reporting however some difficulty or pain at coitus, or to patients who complained about aesthetical problems (123 patients presented a La Peyronie disease and 35 presented a congenital curvature). RESULTS: Eleven patients underwent circumcision during surgery because of a pre-operative phimosis, or according to their own desire. Among the patients who did not undergo circumcision (147), paraphimosis was present in 3 patients. We reported only one case of curvature recurrence in a patient who had a sexual intercourse the day after surgery. We also had one case of hourglass effect in a congenital curvature. DISCUSSION: We believe that some tricks during Nesbit surgical procedure could prevent tissue and vascular trauma that give rise to tissue retraction, and consequently to phimosis and foreskin necrosis: a coronal incision to 0.5-1cm from the gland line would allow to let intact an adequate amount of reflection of skin (prepuce) bound of preputial skin reflection , maintaining good vascularity. The careful degloving with preparatory isolation of the dissection plan between dartos and Buck's fascia, can reduce vascular trauma of the fascia, minimizing bleeding and ensuring tissue vitality. Moreover, execution of only two hydraulics erections, after degloving and after correction, causes a minimal tissue stress. CONCLUSIONS: Circumcision must not be considered a mandatory time in Nesbit procedure: on the contrary, mandatory is the respect of the anatomical structures surgically attacked to avoid preputial resection

Cytokines gene expression in the tunica albuginea of patients with Peyronie’s disease. Pilot study with a control group

INTRODUCTION & OBJECTIVES: Cytokines may be involved in the pathogenesis of the Peyronie's disease (PD). Cytokines levels in tunica albuginea (TA) specimens were measured by Real Time PCR in PD patients and in control group. MATERIAL & METHODS: Between January 2009 and December 2010 20 PD patients affected by PD and 8 patients affected by congenital recurvatum penis (control group) undergoing surgery were entered in the study. Routine histological examination and measurement by Real Time PCR of the expression of the encoding genes for IL-2, IL-4, IL-6, IL-10, IL-13, TGF-β1, TNF-α, IFN-γ and Metalloproteinase (MMP-2) were performed. For the normalization of data, GAPDH (glucerldehyde-3 fosfatehydrogenase) gene normally expressed in all cells was adopted. The analysis of the data was performed using the comparative method of Δct. The target gene expression were reported with the fold of induction (FOI) method calculated according to GAPDH both in PD and in control Group samples. RESULTS: The absence of inflammatory cells was demonstrated by routine histological examination in all samples. A lower median level of gene expression cytokines was detected in the PD patients when compared with the control group: IL-10 0,3864 (range 0- 1,1483), IL-2 0,089 (range 0- 0,3586), IL-6 0,0406 (range 0-0,1478), IFN-γ 0,029 (range 0-0,1187), MMP-2 0,2491 (range 0- 0,6480). IL-4, IL-13 and TNF-α were not detectable. No significant difference emerged between PD and control patients, although a trend for higher levels of TGF-β in PD patients 1,0396 (range 0,1540- 3,6432) vs 1 (control group). CONCLUSIONS: The expression of cytokines in tunica albuginea of PD patients compared to the control patients do not show any significative difference. Cytokines promoting inflammation are undetectable in PD patients and not seem to be involved in the pathogenesis of the disease. A higher level, althoug the difference was not statistically significative of the TGF- β, a profibrotic cytokine, was detected in PD patients representing a possible explain action of fibtotic tissue when the inflammation is off

Sexual dysfunctions after transurethral resection of the prostate (TURP): evidence from a retrospective study on 264 patients

Objectives: Benign prostatic hyperplasia (BPH) and sexual dysfunctions are diseases with a high prevalence in aged men. Several studies have found a link between BPH and LUTS resulting from deterioration in sexual function in men aged 50 years and older for whom TURP is considered the gold standard. The impact of TURP on sexual functions still remain uncertain, nor is it clear what pathophysiological mechanism underlying the emergence of new episodes of Erectile Dysfunction (ED) following TURP in patients with normal sexual function before surgery, while retrograde ejaculation and ejaculate volume reduction represent a clear side effect; derived from BPH treatment. The aim of this study was to retrospectively evaluate the effects of transurethral resection of the prostate (TURP) on sexual function in patients operated in the period 2008-2012 at the Department of Urology of the University Hospital P. Giaccone, and at Villa Sofia-Cervello Hospital- Palermo. Secondary objective was to reconnect the sample data to interventional practice and international standards. Materials and methods: The retrospective longitudinal study was conducted on 264 of the 287 recruitable patients, aged between 50 and 85 years, suffering from BPH who underwent to TURP in the period 2008-2012. Telephone interviews were conducted and the International Index of Erectile Function (IIEF) was administered to assess sexual function. Patients enrolled were asked to respond to the test by referring at first to their sexual status in the period before surgery and subsequently to the state of their sexual function after treatment so as to obtain, for each patient, a pre- and post-TURP questionnaire in order to get comparisons that corresponding to reality and to avoid overestimation of the dysfunctional phenomenon. Results: In the pre-TURP, the 94.32% of the sample reported being sexually active, with good erectile function in 41.3% of cases, ED mild/moderate in 51.5% and complete ED in 1, 5% of cases; good libido in 62.9% of cases, lack of libido in 31.4% of cases and absent in 5.7% of cases (the latter data corresponded to patients not sexually active); to be sexually satisfied in 29.5% of cases, slightly dissatisfied in 11, 7% of cases, moderately in 35.3% of cases, dissatisfied and very dissatisfied in 23.5% of cases (of which 17.8% sexually active and 5.7% non-active).In the post-TURP 89.4% of the sample reported being sexually active, with good erectile function in 39.1% of cases, DE mild/moderate in 46.9% and complete DE in 4% of cases; good libido in 53.8% of cases, lack of libido in 33.7% of cases and absent in 13.5% of cases (including 1.9% of sexually active and 10.6% of non-active); to be sexually satisfied in 29.5% of cases, slightly dissatisfied in 9.5% of cases, moderately in 35.3% of cases, dissatisfied and very dissatisfied in 17.8% of cases (of which 14.8% sexually active and 10.6% inactive). Retrograde ejaculation was referred in 47.8% of those sexually active after TURP (42.8% if we consider the whole sample). Conclusions: TURP had no negative impact on erectile function in contrast to ejaculatory function. Of the109 patients with good erectile function in pre-TURP, 5.8% reported a worsening of erectile function after TURP. Among the 136 patients with ED moderate/mild pre-TURP 3.7% reported a worsening in the post-TURP, 16.2% reported an improvement, while 9.5% stopped any sexual activity. In 3.7% of the cases a complete ED was reported after TURP, while a decline of libido and sexual satisfaction was detected in all patients with worsening of sexual function. Retrograde ejaculation was observed in 48% of those sexually active after TURP. Particular attention has to be paid to the psychological aspects, bothbefore surgery and in the postoperative period, which may become an important factor in the decline of sexual activity

Premature Ejaculation: Comparison of treatment. Pharmacotherapy vs Pharmacotherapy in association with group psychotherapy vs group psychotherapy

Introduction & Objectives: The aim of our study was to compare and analyse the effectiveness of pharmacological treatment and the psychotherapy alone or in association in terms of increase of Quality of Life (QoL) measured through Premature Ejaculation Diagnostic Tool (PEDT) and increase of intravaginal eiaculation latency time (IELT) in patients affected by primitive premature ejaculation(PE). Material & Methods: Between January and December 2012, in our department underwent to medical examination 540 patients complaining PE. Criteria for enrollment were primitive PE with IELT ≤ 2 minutes, PEDT > 9 and absence of psychiatric disease, severe chronic disease, drugs and alcool abuse. Out of 540 patients, 270 were elegible and were enrolled for the study. This patients were randomly divided in 3 group, A,B and C. Patients in Group A were treated with Dapoxetine, mean age 49,8 years(range 20-68). Patients in Group B were treated with Dapoxetine in association with Psycological counselling and group therapy, mean age 49,2 years. Patients in Group C were treated with psycologycal counselling and group therapy alone, mean age 36,9(range 20-56). In the Group A and B was precribed Dapoxetine 30 mg 1 cps 1h before the intercourse with increase in dose to 60mg in case of ineffectiveness. In group B and C after a first psycological counselling one by one patients entered in group therapy with 20 weekly scheduled meetings. All patients were followed for 20 weeks, with 4 schedueld visit during this period. The PEDT was administred before treatment and one month after the end of the therapy. Data were recorded and analysed trought a multivariated analysis. Results: Out of 270 patients enrolled, 120 (44,4%) were compliant to therapy and weren’t evaluable. GROUP A. Out of 90 patients enrolled 60 were compliant to the study. Mean IELT pre-treatment 79,75 sec (range 15 sec–120 sec) and mean PEDT score 15,95 (severe PE). Mean IELT post-treatment 203 sec and mean PEDT 8,26 (moderate PE). Thirteen patients(21,6%) showed an improvement of clinical with mean PEDT score ≤ 8 and IELT ≥ 2 ( p ≤ 0,001). GROUP B. Out of 90 patients enrolled 60 completed the scheduled therapy. Mean IELT pre-treatment 74,83 sec (range 15 sec–120 sec) and mean PEDT score 16 (sever PE). Mean IELT post-treatment 600 sec and mean PEDT 3,3 (absence PE/ light PE) (p ≤ 0,001). In all patients of Group B was detected a reduction of PE. GROUP C. Out of 90 patients enrolled only 30 patients completed the scheduled therapy. Mean IELT pre-treatment 75 sec (range 15 sec–120 sec) and mean PEDT score 15,7. Mean IELT post-treatment 323 sec and mean PEDT 4,03(absence PE/ light PE). Fifteen patients (50%)showed a reduction of PE.All the results analyzed by multivariate analysis were statically significative. Conclusions: Comparing the result obtained in our three groups: in the Group B (Pharmacotherapy plus Psycotherapy) all patients showed an improvement of IELT and PEDT, while in the group A (only Pharmacotherapy)and C (only Psycotherapy) the percentage of patients that reported an improvement of IELT and PEDT were respectively 21,6% and 50%. Our study demonstrate that the psyclogical counselling have a significative role in the treatment of PE. In particulary in association with the pharmacological therapy the psycological group therapy could increase the IELT and ameliorate QoL of patients affected by primitive PE as showed by the decrease of PEDT score

Cytokine gene expression in the tunica albuginea of patients with Peyronie’s disease. Pilot study with a control group

Introduction and objective: Cytokines may be involved in the pathogenesis of Peyronie’s disease (PD). In this case, biological drugs, acting on specific cytokines, could be adopted in the pharmacological treatment of the disease.
Materials and methods: Twenty PD patients and 8 patients affected by congenital recurvatum penis (control group) who underwent corporoplasty were enrolled in the study. Histological examination and measurement by Real Time PCR of the expression of the encoding genes for IL-2, IL-4, IL-6, IL-10, IL-13, TGF-β, TNF-α and IFN-γ were performed on the removed tunica albuginea (TA). For the normalization of data GAPDH (glucerldehyde-3fosfatehydrogenase) and GUSB (β-glucuronidase), housekeeping genes were used. The analysis of the data was performed using the comparative method of ΔCt. The results were reported with the Fold of induction (FOI) method.
Results: The histological exams of TA showed only fibrous tissue without cavernous tissue. The analysis of gene expression of IL-6, IL-10, IFN-γ and TGF-β1 showed in all samples very low levels. The levels were lower in PD patients although the differences were not statistically significant. An exception was represented by TGF-β that showed a higher level in PD patients, although not statistically significant. The expression of IL-4, IL-13 and TNF-α was undetectable.
Conclusions: The expressions of cytokines in TA of PD patients compared to those of the controls do not show any significant difference. A bias of our study is that the groups were not age-matched. This is a bias already present in similar experiences and due to the different pathogenesis of the diseases. Cytokines promoting inflammation resulted undetectable and do not seem to be involved in PD pathogenesis. The higher level of TGF-β, a pro-fibrotic cytokine, detected in PD could explain the presence of fibrotic tissue. Presently, there is no data suggesting a possible role of biological drugs in PD