Ege C Serefoglu1, Ted M Smith2, Gregory J Kaufman2, Genzhou Liu3, Faysal A Yafi4, Wayne J G Hellstrom4. 1. Bagcilar Training & Research Hospital, Department of Urology, Istanbul, Turkey. Electronic address: egecanserefoglu@hotmail.com. 2. Auxilium Pharmaceuticals, Chesterbrook, PA. 3. Endo Pharmaceuticals Inc., Malvern, PA. 4. Tulane University Health Sciences Center, New Orleans, LA.
Abstract
OBJECTIVE: To elucidate patient characteristics that impact symptom-related bother and erectile function in patients with Peyronie disease (PD). METHODS: A post hoc analysis used data from patients with PD (ie, had PD symptoms ≥12 months and penile curvature deformity of 30-90 degrees) who received ≥1 injection of study medication in 2 phase 3 trials of collagenase clostridium histolyticum (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study I [n = 417] and Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study II [n = 415]). The Covariance Analysis of Linear Structural Equations procedure was used to estimate the potential relationship of specified variables on the level of distress and erectile dysfunction associated with PD as measured by the Peyronie's Disease Questionnaire and the International Index of Erectile Function, erectile function domain. RESULTS:Pain during intercourse (P = .02) and PD bother (P <.0001) had a significant impact on International Index of Erectile Function, erectile function scores. The Peyronie's Disease Questionnaire bother domain score was significantly affected by penile curvature deformity, penile shortening, pain during intercourse, and the presence of plaques (P ≤.0005 for all), with pain during intercourse having the greatest impact (maximum likelihood estimation ± standard error = .496 ± .030; P <.0001). Erectile function did not appear to be directly influenced by the presence of plaques, penile curvature deformity, or penile shortening but was associated with PD bother and penile pain. CONCLUSION: This post hoc analysis provides a conceptual framework through which disease characteristics may impact PD-related bother and erectile function in patients with PD.
RCT Entities:
OBJECTIVE: To elucidate patient characteristics that impact symptom-related bother and erectile function in patients with Peyronie disease (PD). METHODS: A post hoc analysis used data from patients with PD (ie, had PD symptoms ≥12 months and penile curvature deformity of 30-90 degrees) who received ≥1 injection of study medication in 2 phase 3 trials of collagenase clostridium histolyticum (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study I [n = 417] and Investigation for Maximal Peyronie's Reduction Efficacy and Safety Study II [n = 415]). The Covariance Analysis of Linear Structural Equations procedure was used to estimate the potential relationship of specified variables on the level of distress and erectile dysfunction associated with PD as measured by the Peyronie's Disease Questionnaire and the International Index of Erectile Function, erectile function domain. RESULTS:Pain during intercourse (P = .02) and PD bother (P <.0001) had a significant impact on International Index of Erectile Function, erectile function scores. The Peyronie's Disease Questionnaire bother domain score was significantly affected by penile curvature deformity, penile shortening, pain during intercourse, and the presence of plaques (P ≤.0005 for all), with pain during intercourse having the greatest impact (maximum likelihood estimation ± standard error = .496 ± .030; P <.0001). Erectile function did not appear to be directly influenced by the presence of plaques, penile curvature deformity, or penile shortening but was associated with PD bother and penile pain. CONCLUSION: This post hoc analysis provides a conceptual framework through which disease characteristics may impact PD-related bother and erectile function in patients with PD.