Login to Access Video or Poster Abstract: MP56-07
Sources of Funding: none

Introduction

Intralesional (IL) injection of CCH is the first FDA approved pharmacotherapy for the treatment of men with PD. This analysis was conducted to define the outcome of IL CCH in our program.

Methods

Study population included men with PD, had stable disease for >3 months, met the other label criteria and underwent IL CCH. Men received up to 8 injections of CCH divided into 4 treatment cycles. Curvature assessments were done at baseline, between cycles 2 and 3 and after cycle 4. Traction therapy was used as our modeling technique to standardize the mechanical therapy. Patient demographics, PD factors and IL CCH complications were recorded. Multivariable analysis (MVA) was used to explore predictors of improvement. Two definitions were used: >10° and >25% improvement. _x000D_ _x000D_

Results

To date, 69 subjects have completed baseline and the mid-treatment assessments (mean age=55±10 years). 25 of these subjects also completed the end of treatment assessment. As baseline, the mean duration of PD was 20.5±20 months. 62% had dorsal curvature, 18% had an hourglass deformity, and 6% had tapering. Mean curvature was 44±20°, and decreased at mid-treatment to 40±20° (p=0.01). For the 25 men who completed the end of treatment assessment, their baseline curvature was 49±23°, and decreased at end of treatment to 44±23° (p=0.12). Three categories of curvature change were created: &[Prime]improvement&[Prime] (>10°); &[Prime]no change&[Prime] (±10° change), and &[Prime]worsened&[Prime] (>10°). After 4 IL CCH injections: 33% improved, 54% had no change, and 13% worsened. After 8 IL CCH injections: 36% improved, 48% no change, and 15% worsened. On univariable analysis, only degree of baseline curvature (r=0.4, p=0.01) was positively correlated to improvement. On multivariable analysis, predicting improvement, baseline curvature remained the only significant predictor of improvement (OR=1.04; 95% CI 1.01-1.07, p=0.04). For improvement defined as >25%, after 4 IL CCH injections, 32% improved and after 8 48% improved. While clinically significant, this difference (between 4 and 8 injections) did not reach statistical significance (p=0.21). There were no significant predictors of improvement of >25% at mid-treatment assessment in either univariable or multivariable analyses.

Conclusions

These data reflect our clinical experience, which is quite different to those presented in the IMPRESS trials. Approximately one third of men significantly improve their penile curvature and it appears that maximum response occurs after 4 injections of CCH.

Funding

none