Does Transfer Capacitive Resistive Energy Has a Therapeutic Effect on Peyronie's Disease? Randomized, Single-Blind, Sham-Controlled Study on 96 Patients: Fast Pain Relief.

Background/Aims/Objectives: We have investigated the clinical and physiological effects of Transfer Capacitive Resistive Energy (TCARE) therapy on men with Peyronie's disease (PD). METHODS: Ninety-six men with PD have been randomized in a 2:1 ratio to receive 3 sessions of TCARE therapy or sham therapy. Pain, penile curvature and erectile function have been assessed before the first treatment and up to 9 months after the end of treatment, using the Visual Analogue Scale for the pain, a goniometer to measure the degree of curvature using at-home photography and an International Index of Erectile Function (IIEF-5) questionnaire. RESULTS: A significant pain reduction at the end of the treatment in 51 (79.6%) patients (p < 0.01) of the treated group was observed. No significant improvements in the sham group (p = 0.23) have been observed. No statistical differences in the degree of curvature have been observed in both groups. No statistical improvements have been observed in the IIEF-5 questionnaire. Adverse events have not been reported. CONCLUSION: This is, to our knowledge, the first randomized, single-blind, sham-controlled study that shows that TCARE has a positive short-term clinical effect on pain in patients with PD. The feasibility and tolerability of this treatment produce an attractive new therapeutic option for men with PD.

Five-year prospective study on cardiovascular events, in patients with erectile dysfunction and hypotestosterone.

OBJECTIVE: Testosterone levels play a role in cardiac and vascular pathology. In the present study we investigated the prognostic significance of this hormone for cardiovascular outcome, in a 5-year follow-up. MATERIALS AND METHODS: Our cohort included 802 adult subjects, from 40 to 80 years. Patients were excluded if they had a past history of peripheral or coronary artery disease, and revascularization. A blood sample was drawn to valuate testosterone level, and we considered normal testosterone levels 300 ng/dl. FMD (flow mediated dilatation) of the brachial artery was assessed by measuring the increase of the brachial artery diameter during reactive hyperemia after transient forearm ischemia. B-mode longitudinal images of the brachial artery were obtained at the level of the antecubital fossa. The FMD was defined as the percentage change in the brachial artery diameter 60 s after releasing the ischemic cuff. Erectile dysfunction (ERD) was assessed by the International Index of Erectile Function-5 (IIEF-5) score questionnaire. We considered composite end points including the following major adverse cardiovascular events (MACEs) Results: Subjects with lower serum testosterone levels (n = 332) had higher prevalence of traditional cardiovascular risk factors, such as hypertension (p = 0.009), diabetes (p = 0.03), dyslipidemia (p < 0.0001), obesity (p = 0.002), and endothelial function score (p < 0.0001). AMI, death after AMI, major stroke and all clinical events were more frequent (p < 0.001) in patients with testosterone levels < 300 ng/dl. Further, by multiple logistic regression analysis we found that only dyslipidemia (p = 0,001), obesity (p = 0,007), testosterone < 300 ng/dl (p < 0,0001) and ED (p < 0,0001) were independent predictors of future events. CONCLUSIONS: A therapeutic intervention on testosterone may not only have a positive effect on the cardiovascular system but also an important role in preventing new cardiovascular events.

[TECAR therapy for Peyronie's disease: a phase-one prospective study. Great evidence in patients with erectile dysfunction]. / Il Trasferimento Energetico Capacitivo Resistivo (TECAR) nella terapia dell'Induratio Penis Plastica: studio pilota di fase uno sulla tollerabilità, sulla sicurezza e sull'applicabilità della tecnica. Quali altri risvolti sorprendenti.

Our phase-one prospective study wants to evaluate the safety and tolerability of TECAR therapy in the treatment of Peyronie's disease. From June 2011 to September 2012 we enrolled 70 patients. Each patient had been previously subjected to andrological examination, to a questionnaire for the evaluation of IPP and ED, and the SF-36 (V1) for the evaluation of the general state of health. The evaluation of pain was made using the VAS scale of pain. Every patient was subjected to TECAR treatment of the fibrotic plaque (both in resistive mode and in capacitive mode) for a total of three sessions carried out on consecutive days. We recorded a good compliance by patients; none of them reported side effects. Pain was decreased by the technique in 80% of the cases.The whole sample completed the study. Surprisingly enough those patients who complained also of erectile dysfunction, reported an improvement in sexual potency.

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

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.

Safety and tolerability of local treatment with iloprost, a prostacyclin analogue, in patients with Peyronie's disease: a phase I study.

UNLABELLED: Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Peyronie's disease (PD) is an acquired curvature of the penis attributable to progressive fibromatosis of the tunica albuginea (TA). It is frequently associated with Dupuytren's contracture and those of Ledderhose. More recently it was found that patients suffering from PD also often suffer from diabetes mellitus and gout. Cigarette smoking and the intake of large amounts of alcohol are considered risk factors for PD.The exact aetiology of the disease is unknown, however, the trauma hypothesis is shared by most authors. According to this theory, repeated sexual microtrauma in people genetically predisposed could cause PD. The inflammatory process leads to the formation of fibrosis and plaques. Plaque can lead to penile curvature and may reduce its functionality. Pain is the most common symptom of early-stage disease. In the late stages the pain disappears, but erectile dysfunction may occur. Surgical treatment is available, but this exposes the patient to a greater risk of erectile dysfunction and it is most frequently associated with a reduction in the length of the penis. The rationale for local medical therapy is to use a treatment that acts on the initial phase of the disease by reducing and stopping the processes that lead to fibrosis, thus stabilizing the disease. Systemic medical therapy is usually accompanied by high rates of recurrence. Many authors consider local drug therapy more appropriate. Local treatment consists of several types of medication, but results are often sub-optimal. Anti-inflammatory or immunoregulatory therapy, either systemic or topical, has shown some efficacy when administered early in the disease by modulating the inflammatory response and attenuating the alteration of tissue repair. Unfortunately, in most cases, patients are first seen when the plaque is chronically inflamed, stabilized and sometimes already calcified. We have tested a biological drug for intralesional administration for the first time. We chose iloprost, an analogue of prostacyclin I2, for its theoretically favourable properties. If used i.v., it has been shown to be effective in treating vascular ischaemic disease such as thromboangioitis obliterans, peripheral arterial occlusive disease, Raynaud's phenomenon and systemic sclerosis. The rationale for the therapeutic use of iloprost in the late stages of PD is based on the assumption that activation of fibrinolysis induced by the drug would be able to determine a regression of the plaque with a consequent reduction of the curvature on erection. The main purpose of this phase I study was to evaluate the safety and tolerability of this drug injected in the context of the fibrous plaque on a small number of patients before designing a large-scale randomized trial. According to the results,therapy with intralesional iloprost in Peyronie's disease seems to be safe and tolerated and is a possible alternative to surgery. OBJECTIVE: To assess the safety and tolerability of intralesional injections of iloprost (an I2 prostacyclin analogue) for its ability to suppress the production of connective tissue growth factor in fibroblasts, for the treatment of Peyronie's disease (PD). PATIENTS AND METHODS: A total of 38 patients with PD were preliminarily assessed according to symptoms, the degree of penile curvature and the size and number of plaques. Each patient received weekly intralesional injections of iloprost 200 ng in 1 mL normal saline for 5 weeks. If tolerated, the single dose was increased weekly to the maximum of 400 ng (2 mL). All the patients were preliminarily evaluated using at-home photography and were re-evaluated 2 months after the end of the treatment regimen. There was no placebo control group in this phase I study. RESULTS: Almost all patients showed mild side effects (burning or pain) during the treatment at the site of injection. All patients tolerated well a iloprost dose of 200 ng; 19 patients reached a 300 ng dose and 14 tolerated a 400 ng dose without showing side effects. A total of 29% of the patients showed an improvement in curvature. CONCLUSION: The results show that therapy with intralesional iloprost is a possible alternative to surgery for Peyronie's disease.

[Penile Flexiflate® Surgitek prosthesis explant and simultaneous three-component hydraulic Titan® Alpha 1 prosthesis implantation, with double incision technique in a patient with kidney and pancreas transplant]. / Espianto di protesi peniena Flexiflate® Surgitek e contemporaneo impianto di protesi tricomponente idraulica Titan® Alpha 1, con tecnica a doppia incisione in paziente con trapianto di rene e pancreas.

INTRODUCTION AND OBJECTIVES: We treated a 45 years old patient, suffering from diabetes mellitus since childhood, with retinal, neurovascular and kidney complications. In 1988, for erectile dysfunction (ED) resistant to medical injective treatment, the patient underwent ligation of the dorsal vein of the penis without any result. In 1989 a Flexiflate® hydraulic prosthesis was implanted with resolution of ED. In 2005 the patient underwent simultaneous kidney and pancreas transplant with a trans-laparotomic approach for end stage renal disease and diabetes mellitus. In 2009, because of the Flexiflate® Surgitek malfunction, the patient underwent explantation of the Flexiflate® prosthesis and simultaneous implantation of a Titan® Alpha 1 prosthesis with a double surgical approach. MATERIAL AND METHODS: After a peno-scrotal incision and the explant of the Flexiflate® Surgitek, a Titan® Alpha 1 prosthesis was implanted with a double incision technique. The placement of two inflatable cylinders and the pump was performed by peno-scrotal approach. Instead, the prosthesis' reservoir was placed with a separate infra-pubic incision to avoid possible injury from a single trans-inguinal approach, due to the previous laparotomy. RESULTS: After follow-up at 9 months and 1 year the prosthesis was working well and the patient satisfied. CONCLUSIONS: We couldn't find any related paper in the literature and as far as we know this is the only report on a simultaneous explant/implant of penile prosthesis with a double surgical approach in a patient with kidney and pancreas transplant.

[Safety and tolerability of local treatment with Iloprost in patients with Peyronie's disease. A phase 1 pilot study and proposal of a new symptom questionnaire]. / Sicurezza e tollerabilità del trattamento locale con Iloprost in pazienti affetti da malattia di La Peyronie. Studio pilota di fase 1 e proposta di nuovo questionario per la valutazione sintomatologica.

PURPOSE: Intralesional therapy is a less invasive method for the treatment of Peyronie's disease. The objective of this study was to evaluate safety and tolerability of intralesional injections of Iloprost (I2 Prostacyclin analogue) for its property to suppress in fibroblasts CTFG (Connective tissue growth factor) production, which acts in concert with TGF-ß to stimulate the fibrotic process. METHODS: Nineteen patients with Peyronie's disease were preliminarily evaluated by considering the degree of penile curvature, plaque size and local and systemic symptoms. Each patient then received weekly intralesional injections of 200 ng of Iloprost in 1 ml of normal saline for 4-5 weeks. If tolerated, the single dose increased weekly to the maximum of 400 ng (2 mL). RESULTS: The treatment has shown that all patients seem to well tolerate a 200 ng Iloprost dose; 7 of them reached a 300 ng dose and 6 tolerate a 400 ng dose without showing side effects. There was no placebo control group in this study. To evaluate the efficacy of the treatment, the absence of objective parameters (except for the auto-photograph of penis in erection) led us to develop a subjective questionnaire that was given to all patients to assess sexual function, pain reduction, ecc. CONCLUSIONS: Due to the relatively small size of the sample, the efficacy evaluation has been restricted to check the questionnaire reliability. Iloprost is well tolerated to a dose of 400 ng in the local treatment of Peyronie's disease.