A. Fraile

Penile traction therapy with the new device ‘Penimaster PRO’ is effective and safe in the stable phase of Peyronie's disease: a controlled multicenter study

To evaluate the efficacy and safety of a new penile traction device (PTD), ‘Penimaster PRO’, in a group of patients with stable Peyronies disease (PD) compared with a non‐intervention group in a multicentre study.

PD31-09 PENILE PROSTHESIS IMPLANTATION (PPI) PLUS CORPOREAL RECONSTRUCTION WITH COLLAGEN-FLEECE GRAFTING IN THE TREATMENT OF PEYRONIE’S DISEASE (PD) WITH OR WITHOUT ED

hourglass deformity. The success and feasibility of surgically correcting residual curvature after intralesional CCH remains poorly characterized. METHODS: We performed a retrospective analysis of patients who had intralesional CCH treatment for Peyronie0s disease (PD) who subsequently underwent penile plication (PP), plaque incision and grafting (PIG), or inflatable penile prosthesis (IPP) placement as part of their treatment for residual curvature. RESULTS: Nine men who underwent PP, PIG, or IPP for the treatment of residual curvature after intralesional CCH were identified (Table). Six patients underwent PP, one patient underwent PIG and two patients underwent IPP with ancillary straightening maneuvers. The mean time (in days) from the last CCH injection to surgical correction was 128.9. The mean pre-CCH curvature was 69.4 degrees and the mean post-CCH curvature was 52.78 degrees. Seven out of nine patients had no residual curvature after surgical treatment. Increased fibrosis with increased surgical difficulty was noted in three out of nine patients. No post-operative complications were noted. CONCLUSIONS: The surgical treatment of PD after intralesional CCH is safe and effective in men who desire correction of residual curvature. There may be increased technical difficulty in some patients.

MP56-06 CLINICAL OUTCOMES OF THE USE OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (CCH) FOR PEYRONIE'S DISEASE (PD)

INTRODUCTION AND OBJECTIVES: Collagenase clostridium histolyticum (CCH)is the only licensed product for the treatment of Peyronie’s disease (PD). The clinical safety and efficacy of CCH in PD was shown in two large clinical trials; IMPRESS I & II. The aim of this study is to evaluate the efficacy and safety of CCH in the treatment of PD using a new modified treatment protocol which aims at reducing the number of injections needed and reducing patient visits, thus reducing the cost and duration of treatment. METHODS: A prospective study of 50 patients with PD who are having treatment with CCH at a single centre using a new modified protocol. Patients with active disease, complete plaque calcification or ventral curvature were excluded. The angle of curvature assessment after an intra-cavernosal injection of PGE1, IIEF and Peyronie’s disease questionnaire (PDQ) were performed at baseline and at week 12. The global assessment of PD questionnaire was performed at week 12. Under a penile block of 10ml of lignocaine 1%, a total of 3 intra-lesional injections of CCH (0.9mg) were given at 4 weekly intervals using a new modified injection technique. CCH was injected in the plaque along 3 lines separated by 2mm at the apex of the curvature with the penis in the flaccid state. Six patients requested an additional 3 injections to have a total of 6 injections. In between injections patients used a combination of home modelling, stretching and a vacuum device on a daily basis in order to mechanically stretch the plaque. Investigator modelling was not performed. RESULTS: So far 46 patients have completed treatment; all had 3 injections. At baseline, the mean penile curvature was 53.8 (30 90 ). Overall, 44 patients (95.6%) had an improvement in curvature with a mean value of 17.08 (0 -40 ) or 30.8% from baseline (0-57%) after 3 injections. The end mean curvature for all patients after 3 injections was 37 (12 75 ; p 0.001). There was a statistically significant improvement in each of the IIEF questionnaire domains, all 3 PDQ domains and the global assessment of PD questionnaire. The 6 patients who had 3 more injections continued to have additional curvature improvement, mean 19.8 (0 -40 ). CCH was well tolerated by all patients with only mild and transient local side effects. The results of this study with only 3 CCH injections are comparable to those of the clinical trials using 8 CCH injections. With the new protocol, only 4 patient visits are needed including assessments versus 14 visits as per trial protocol. CONCLUSIONS: The new shortened protocol for CCH in PD is safe, effective and cost efficient.

MP45-05 ACTIVATION OF NRF2 IMPROVES ENDOTHELIAL FUNCTION IN CORPUS CAVERNOSUM FROM AGED RATS AND IN CORPUS CAVERNOSUM AND PENILE ARTERIES FROM ED PATIENTS

INTRODUCTION AND OBJECTIVES: Adequate antioxidant response is essential for tissue homeostasis and function. However, systems responsible for antioxidant response are down-regulated in some pathological situations and aging. This is the case for Nrf2 that orchestrates cellular response to oxidative stress. The aim was to evaluate pharmacological activation of Nrf2 on the impairment of endothelial relaxation and reactive oxygen species-induced responses in corpus cavernosum (CC) from aged rats and in CC and penile arteries from patients with erectile dysfunction (ED). METHODS: Endothelium-dependent relaxations to carbachol and responses to H2O2 were evaluated in CC from 3-months (young) and 20-months (aged) old rats in the absence or the presence of the Nrf2-activators, sulforaphane (10 microM) and oltipraz (30 microM). Upregulation of Nrf2 was assessed by ELISA. The effects of these Nrf2activators were also evaluated on endothelial relaxation and H2O2induced responses in human corpus cavernosum (HCC) and penile resistance arteries (HPRA) obtained from patients undergoing penile prosthesis implantation. RESULTS: Aged rats CC displayed ED and impaired endothelium-dependent and H2O2-induced relaxation. Ex vivo exposure to either sulforaphane or oltipraz improved endothelial and H2O2-induced relaxation of CC from aged rats. HCC and HPRA were obtained from 19 patients (age: 60.7þ/-2.0 years, hypertension: 8, dyslipidemia: 7, diabetes: 6, CVD: 4, obesity: 2). Treatment with sulforaphane improved endothelium-dependent (pD2 for acetylcholine: 5.18þ/-0.28 vs 6.34þ/0.37*) as well as neurogenic relaxation (Emax: 45.7þ/-6.4% vs 60.9þ/3.0%*) in HCC. Sulforaphane also improved endothelial (pD2 for acetylcholine: 5.82þ/-0.38 vs 7.21þ/-0.32*) and H2O2-induced vasodilation in HPRA (pD2 for H2O2: 4.13þ/-0.13 vs 5.07þ/-0.17*). Positive effects of Nrf2-activation were confirmed by the improvement of endothelial vasodilation driven by oltipraz in HPRA. CONCLUSIONS: Pharmacological activation of Nrf2 improves cavernosal function in aged animals with ED. These effects were confirmed in human tissue, including penile arteries, from patients with ED, suggesting that Nrf2 activation could be a reasonable target for the management of ED.