Baseline Characteristics from an Ongoing Phase 3 Study of Collagenase Clostridium Histolyticum in Patients with Peyronie's Disease. (24th September 2013)

• Record Type: Journal Article
• Authors: Gelbard, Martin; Hellstrom, Wayne J.G.; McMahon, Chris G.; Levine, Laurence A.; Smith, Ted; Tursi, James; Kaufman, Gregory; Goldstein, Irwin
• Is Part Of: Journal of sexual medicine. Volume 10:Number 11(2013:Nov.)
• Page Start: 2822
• Page End: 2831
• Publication Date: 2013-09-24
• Subjects: Peyronie's Disease -- Penile Induration -- Clostridium Histolyticum -- Questionnaires; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1111/jsm.12312
• Languages: English
• ISSNs: 1743-6095

Abstract

Abstract: Introduction: Peyronie's disease (PD) is a localized penile collagen disorder of the tunica albuginea associated with significant physical deformity and psychological impairment. Current understanding of pretreatment characteristics in patients with chronic PD is limited by small samples, varied quality of assessments, and the lack of a PD‐specific, validated measure of the psychosexual impact of PD. Aims: Reporting baseline demographic and disease characteristics of the large multinational cohort of subjects with chronic PD who participated in the collagenase clostridium histolyticum (CCH, an investigational intralesional injection and minimally invasive intervention) phase 3 clinical study program. Findings from well‐defined assessments, including the Peyronie's Disease Questionnaire (PDQ), the first validated PD‐specific patient‐reported measure of psychosexual impact, are reported. Methods: Subjects included men ≥18 years old with PD symptoms ≥12 months and penile deformity between 30° and 90°. Analysis data included demographics, disease history, and psychosexual impact. Main Outcome Measures: Penile deformity, disease symptoms, the International Index of Erectile Function, and the PDQ were assessed. Results: Eight hundred thirty‐two subjects were enrolled from 64 sites across the United States and Australia. The mean age was 57.7 years; mean PD duration was 4.1 years. The majority of subjects had penile deformity ≤60° (77.3%); mean penile deformity was 50.5°. Subjects reported having intercourse a mean of 10.2 times in the previous 3 months, 70.8% reported difficulty in performing vaginal intercourse, and 80.4% reported less frequent vaginal intercourse. Approximately 71.5% of subjects with severe (>60°) and 58.1% of subjects with mild/moderate (≤60°) penile deformity were "very bothered" or "extremely bothered" upon last look at their erect penis ( P = 0.0041), as measured by the PDQ. Conclusions: These data add to the body of knowledge regarding the clinical impact of chronic phase PD, including the PD‐specific patient‐reported psychosexual symptoms, using a large multinational chronic PD cohort in the CCH phase 3 clinical program.G elbard M, H ellstrom WJG, M c M ahon CG, L evine LA, S mith T, T ursi J, K aufman G, and G oldstein I . B aseline characteristics from an ongoing phase 3 study of collagenase clostridium histolyticum in patients with P eyronie's disease. J S ex M ed 2013;10:2822–2831.