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Clinical Trial
Journal Article
Restoration of Penile Function and Patient Satisfaction with Intralesional Collagenase Clostridium Histolyticum Injection for Peyronie's Disease.
Journal of Urology 2016 April
PURPOSE: Collagenase clostridium histolyticum is approved for the treatment of Peyronie's disease. To date, no post-release study to our knowledge has evaluated patient perceived outcomes and satisfaction. Therefore, we evaluated patient perceived experience with collagenase clostridium histolyticum injection for Peyronie's disease in a clinical practice.
MATERIALS AND METHODS: From March 2014 to July 2015, 69 patients underwent 1 to 4 series of collagenase clostridium histolyticum injections for Peyronie's disease at our institution. Objective changes in penile curvature as well as patient reported functional outcomes and patient perceived curvature improvements were evaluated.
RESULTS: By the time of analysis 31 patients (45%) had completed 4 trials, 47 (68%) completed 3 trials and 59 (86%) completed 2 trials. Patient reported improvements (percentage) in curvature increased with each series (trial 1-14%, trial 2-28%, trial 3-30% and trial 4-37%, p <0.05). Among those completing therapy 57% reported that collagenase clostridium histolyticum injections negated a need for surgery and 52% reported restoration of penetration. Overall 81% of men perceived collagenase clostridium histolyticum treatment as meaningful and 88% reported subjective improvements after 4 series of injections. Objective measures demonstrated a mean 23-degree curvature improvement (38%, p <0.0001). Seven patients (10%) experienced penile hematomas and no patients experienced tunical rupture.
CONCLUSIONS: Collagenase clostridium histolyticum reduced the need for surgery and restored penetration in the majority of patients completing 4 series of injections. It also significantly reduced the degree of objectively measured penile curvature. Subjective improvements in curvature increased with each series of collagenase clostridium histolyticum injections as well and the majority of patients considered the therapy worthwhile.
MATERIALS AND METHODS: From March 2014 to July 2015, 69 patients underwent 1 to 4 series of collagenase clostridium histolyticum injections for Peyronie's disease at our institution. Objective changes in penile curvature as well as patient reported functional outcomes and patient perceived curvature improvements were evaluated.
RESULTS: By the time of analysis 31 patients (45%) had completed 4 trials, 47 (68%) completed 3 trials and 59 (86%) completed 2 trials. Patient reported improvements (percentage) in curvature increased with each series (trial 1-14%, trial 2-28%, trial 3-30% and trial 4-37%, p <0.05). Among those completing therapy 57% reported that collagenase clostridium histolyticum injections negated a need for surgery and 52% reported restoration of penetration. Overall 81% of men perceived collagenase clostridium histolyticum treatment as meaningful and 88% reported subjective improvements after 4 series of injections. Objective measures demonstrated a mean 23-degree curvature improvement (38%, p <0.0001). Seven patients (10%) experienced penile hematomas and no patients experienced tunical rupture.
CONCLUSIONS: Collagenase clostridium histolyticum reduced the need for surgery and restored penetration in the majority of patients completing 4 series of injections. It also significantly reduced the degree of objectively measured penile curvature. Subjective improvements in curvature increased with each series of collagenase clostridium histolyticum injections as well and the majority of patients considered the therapy worthwhile.
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