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Baseline Characteristics from an Ongoing Phase 3 Study of Collagenase Clostridium Histolyticum in Patients with Peyronie's Disease

2013; Elsevier BV; Volume: 10; Issue: 11 Linguagem: Inglês

10.1111/jsm.12312

1743-6109

Martin K. Gelbard, Wayne J.G. Hellstrom, Chris G. McMahon, Laurence A. Levine, Ted Smith, James P. Tursi, Gregory J. Kaufman, Irwin Goldstein,

Sexuality, Behavior, and Technology

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. Gelbard M, Hellstrom WJG, McMahon CG, Levine LA, Smith T, Tursi J, Kaufman G, and Goldstein I. Baseline characteristics from an ongoing phase 3 study of collagenase clostridium histolyticum in patients with Peyronie's disease. J Sex Med 2013;10:2822–2831.