To evaluate the efficacy and safety of collagenase clostridium histolyticum (CCH) (Xiapex(®) , Xiaflex(®) ) in the treatment of Peyronie's disease (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.
A prospective study of 53 patients with PD who had treatment with CCH at a single center using a new modified protocol. The angle of curvature assessment after an intra-cavernosal injection of PGE1, IIEF and Peyronie's disease questionnaires (PDQ) were performed at baseline and at week 12 (4 weeks after the last injection). The global assessment of PD questionnaire was performed at week 12. Under a penile block of 10ml of plain 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. 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.
The mean penile curvature at baseline was 54° (30 - 90°). Of the 53 patients in the study, 51 patients (96.2%) had an improvement in the angel of curvature with a mean value of 17.36° (0°- 40°) or 31.4% from baseline (0 - 57%) after 3 CCH injections. The end mean curvature was 36.9° (12 °- 75°; p<0.001). There was an improvement in each of the IIEF questionnaire domains, all 3 PDQ domains and the global assessment of PD questionnaire. CCH was well tolerated by all patients with only mild and transient local adverse events.
The new shortened protocol using CCH treatment is safe, effective and cost efficient. The results of using only 3 CCH injections according to this modified protocol are comparable to those of the clinical trials which used 8 CCH injections. This article is protected by copyright. All rights reserved.
BJU international. 2017 Jun 14 [Epub ahead of print]
Amr Abdel Raheem, Marco Capece, Odunayo Kalejaiye, Tarek Abdel-Raheem, Marco Falcone, Mark Johnson, Oliver George Ralph, Giulio Garaffa, Andrew Nim Christopher, David John Ralph
Andrology Department, University College London Hospital & The Institute of Urology London.