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C.S. Fuglesang Jensen, S. Quallich, M. Fode, J. Sønksen, B.S. Malaeb, D.A. Ohl, HP-09-002 Outcomes from a Single-center Prospective Post-marketing Study on Collagenase Clostridium Histolyticum Injections for Peyronie’s Disease, The Journal of Sexual Medicine, Volume 16, Issue Supplement_2, May 2019, Pages S46–S47, https://doi.org/10.1016/j.jsxm.2019.03.160
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Objective
To prospectively evaluate outcomes of Collagenase Clostridium Histolyticum injections (CCHi) for Peyronie’s Disease.
Methods
IRB approval was obtained for this study. Data was prospectively collected to evaluate patients undergoing treatment with CCHi for Peyronie’s Disease between 01/2016-08/2018. A total of 34 patients with dorsal, dorsolateral or lateral penile curvatures between 30-90 degrees, and treated with 1-4 cycles of CCHi, were asked to fill out the “bother domain” of the Peyronie’s Disease Questionnaire (PDQ) at scheduled appointments for injections. Seven patients were excluded from analysis due to missing baseline values. Each CCHi cycle involved two injections (0.58mg) separated by 48-72 hours. Cycles were separated by at least 6 weeks. A one-way repeated measures ANOVA was conducted to evaluate the null-hypothesis that there is no change in patients’ PDQ scores following injections. Pairwise comparisons were performed using paired samples t-test.
Results
Patients had a mean (standard deviation) age of 60 (9) years and a mean pre-treatment curvature degree of 56 (20) degrees. The curvature direction was dorsal, dorsolateral and lateral in 22, 2 and 3 patients, respectively. The mean baseline PDQ bother domain scores was 11.1 (2.6). ANOVA results demonstrated a statistically significant effect of injections (p < 0.001) with statistically significant decreases in PDQ bother domain scores 6 weeks after the first cycle (9.9 (3.3) , p = 0.013), 6 weeks after the second cycle (8.2 (4.0) , p = 0.009) and 6 weeks after the third cycle (6.5 (3.6) , p < 0.001). After 2-4 cycles of CCHi patients reported changes in penile curvature as “Worse” (0), “No Change” (2), “Little decrease” (10), Decrease (10) and “Significant decrease” (4).