Login to Access Video or Poster Abstract: MP56-04
Sources of Funding: Non

Introduction

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._x000D_ _x000D_ 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._x000D_

Methods

A prospective study of 50 patients with PD who are having treatment with CCH at a single centre using a new modified protocol. _x000D_ _x000D_ Patients with active disease, complete plaque calcification or ventral curvature were excluded._x000D_ _x000D_ 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. _x000D_ _x000D_ 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. _x000D_ _x000D_ Six patients requested an additional 3 injections to have a total of 6 injections._x000D_ _x000D_ 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. _x000D_ _x000D_ Investigator modelling was not performed._x000D_

Results

So far 46 patients have completed treatment; all had 3 injections._x000D_ _x000D_ 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). _x000D_ _x000D_ There was a statistically significant improvement in each of the IIEF questionnaire domains, all 3 PDQ domains and the global assessment of PD questionnaire._x000D_ _x000D_ The 6 patients who had 3 more injections continued to have additional curvature improvement, mean 19.8° (0°-40°). _x000D_ _x000D_ CCH was well tolerated by all patients with only mild and transient local side effects. _x000D_ _x000D_ 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._x000D_

Conclusions

The new shortened protocol for CCH in PD is safe, effective and cost efficient.

Funding

Non