IntroductionHyaluronic acid has been shown to be efficacious in decreasing scar formation, inflammation, and oxidative stress.AimTo assess the efficacy of intralesional injection of hyaluronic acid in patients affected by Peyronie's disease.MethodsIn this prospective, single-arm, self-controlled, interventional, multicenter pilot study, 65 patients underwent a 10-week cycle of weekly intraplaque injections with hyaluronic acid (0.8% highly purified sodium salt hyaluronic acid 16 mg/2 mL; Sinovial, IBSA, Lodi, Italy). Patients were re-evaluated 2 months after the end of therapy.Main Outcome MeasuresPlaque size (millimeters), penile curvature (degrees), International Index of Erectile Function (IIEF-5) score, visual analog scale (VAS) score for sexual satisfaction, and Patient's Global Impressions of Improvement (PGI-I) score.ResultsMedian age was 57 years (range = 23–70). At baseline, mean plaque size was 10 mm (range = 3–30 mm), mean penile curvature was 30° (range = 0°–50°), and mean IIEF-5 score was 20 (range = 0–25), with slight to moderate erectile dysfunction (IIEF score < 21) in 36 of 65 patients (55%). A median VAS score of 6 (range = 2–10) was found. Mean follow-up was 12 months (range = 6–24 months). Statistically significant post-treatment improvements were detected for plaque size (before treatment = 10 mm [3–30 mm], after treatment = 8 mm [1–30 mm], P < .0001), penile curvature (before treatment = 30° [0°–50°], after treatment = 20° [0°–40°], P < .0001), IIEF-5 score (before treatment = 20 [11–25], after treatment = 21 [15–25], P < .0001), and VAS score (before treatment = 6 [2–10], after treatment 8 [2–10], P < .0001). After treatment, the rate of patients with an IIEF score lower than 21 decreased from 55% (36 patients) to 40% (25 patients). Overall improvement on the PGI-I questionnaire was 69%.ConclusionIntralesional treatment with hyaluronic acid can improve plaque size, penile curvature, and overall sexual satisfaction and seems preferably indicated in the early (active) phase of the disease. Furthermore, it is easy to perform and well tolerated.
Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I.
Peyronie’s disease (PD) is a chronic disorder involving the tunica albuginea surrounding the corpora cavernosa of the penis. A conservative treatment is indicated in the first stage of disease. The aim of this study was to assess the therapeutic impact and possible side effects of treatment with pentoxifylline (PTX) in combination with other antioxidants in 307 patients with early-stage PD. Patients were subdivided into three groups: A, B, and C. Both groups, A and B, comprising of 206 patients, underwent treatment, whereas Group C was the control group (n=101). Treatment lasted 6 months and included the following: Group A: PTX 400 mg twice a day + propolis 600 mg/d + blueberry 160 mg/d + vitamin E 600 mg/d + diclofenac 4% gel twice/a day + PTX 100 mg via perilesional penile injection/every other week (12 injections in all); Group B: the same treatment as Group A except for the penile PTX injections. After the 6-month treatment course, we obtained the following results: actual mean decrease in plaque volume −46.9% and −24.8% in Group A and B, respectively (P<0.0001); mean curvature reduction −10.1° and −4.8°, respectively (P,0.0001); resolution of pain in 67.6% and 67.2% of cases, respectively (P=0.961); recovery of normal penile rigidity in 56.09% and 23.5% of cases, respectively (P=0.005). After 6 months, progression of disease was observed in all patients belonging to Group C: plaque volume +123.3%; curvature +15.7°; no recovery of penile rigidity. The statistically significant results of our study show that multimodal treatment with PTX in association with other antioxidants and topical diclofenac is efficacious in treating early-stage PD. Furthermore, treatment proved to be more effective when PTX was administered both orally and by penile injection. No serious adverse effects occurred.
Abstract. Robotic-assisted radical prostatectomy (RARP) shows measurable advantages, compared to conventional open surgery, even if some aspects are, still, under debate. The aim of this study was to compare the potency recovery rate of patients with clinically localised prostate cancer treated by bilateral nerve-sparing (BNS) RARP or retropubic radical prostatectomy (RRP), and secondarily, the urinary continence recovery evaluation and the oncological efficacy. All patients treated with BNS-RARP or BNS-RRP for clinically localised prostate cancer, performed by a single dedicated surgeon, between January 2004 and December 2008, were enrolled in this non-randomised prospective comparative study. The International Index of Erectile Function (IIEF) and erection hardness score (EHS), in the form of a questionnaire, were self-administered to each patient pre-operatively and after 12 months. The presence of surgical margins was considered as oncological outcome measure. Eighty-two patients underwent BNS-RARP while 48 underwent BNS-RRP. For BNS-RARP and BNS-RRP the median operative time was 221 and 103 min, respectively (P<0.001; df=128; t=721.43),and intra-operative blood loss was 280 and 565 ml, respectively (P<0.001; df=128; t=1742.44). At a mean follow-up period of 12.4±2.3 months, 12 patients (25%) in the BNS-RRP group and 22 (26.8%) in the BNS-RARP group were considered potent with or without drugs (P=0.81). Moreover, we did not find any statistically significant difference between the 2 groups in terms of IEFF and EHS scores after treatment (17.21 vs. 16.98; P=0.16 and 2.1 vs. 2.0; P=0.54). On the other hand, statistically significant differences between the 2 groups were found in terms of faster urinary continence recovery and the presence of positive surgical margins (P<0.001, P=0.009). Shorter catheterization duration (7 vs. 3 days) and post-operative hospital stays (8 vs. 4 days; P<0.001) were found in the BNS-RARP group compared to the BNS-RRP group. In conclusion, our results demonstrate that BNS-RARP does not improve erectile function recovery compared to open radical prostatectomy; however, it significantly improves urinary continence and decreases the presence of positive surgical margins.
Lichen sclerosus (LS) is an inflammatory and chronic disease that causes itching, pain, dysuria, urinary retention, dyspareunia and sexual dysfunction, in both men and women. The first line pharmacological treatment is based on the use of topical steroids, which have proved their efficacy in 60-70% of cases but with a high rate of relapses in time (50-80% of the patients of both sexes). The purpose of our non-randomised prospective pilot study was to evaluate the efficacy and tolerability of a new loco regional therapy with polydeoxyribonucleotides (PDRN) in the treatment of male genital LS. PDRN is an healing and anti-dystrophic drug with anti-inflammatory effects, through the reduction of cytokine. Twenty one male patients suffering from genital LS were recruited. All the patients were submitted to treatment using loco-regional intradermal injections with PDRN. Dermatology Life Quality Index (DLQI), International Index of Erectile Function (IIEF-5) and PGI-I questionnaires were administered at baseline and at the end of treatment in order to evaluate the results of this treatment. The statistical evaluation of the data obtained with the DLQI questionnaire showed a marked improvement of the overall conditions in terms of quality of life, with an average change of scores from 15 to 4 (p < 0.0001). PGI-I questionnaire showed that 80% of the patients treated considered their post-treatment conditions as ‘improved'. There was no significant change in terms of sexual function according to the IIEF questionnaire (p = 0.189). The results obtained show the excellent tolerability and the therapeutic efficacy of PDRN, with clear improvement of the local symptoms and of the quality of life.
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