title: Self-report and Clinical Response to Peyronie's Disease Treatment: Peyronie's Disease Questionnaire Results From 2 Large Double-Blind, Randomized, Placebo-Controlled Phase 3 Studies.
abstract: OBJECTIVE
  To evaluate the clinical usefulness of the Peyronie's Disease Questionnaire (PDQ). The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie's disease (PD) treatment was examined.
  
  
  METHODS
  Combined data from the collagenase Clostridium histolyticum phase 3 study program, IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II, were examined. Changes in the PDQ PD symptom bother, psychological and physical symptoms, and penile pain were examined relative to changes in the penile curvature deformity, including penile curvature absolute mean and percent change. PDQ changes relative to sexual function, including International Index of Erectile Function overall satisfaction and erectile function domains, and treatment responder status, including global assessment of PD and composite responder status, were also assessed. Individual PDQ questions were examined to provide a clinical perspective on the change in psychosexual symptoms experienced by men with PD during treatment.
  
  
  RESULTS
  Improvement in PDQ PD symptom bother and psychological and physical symptoms was significantly correlated with clinical improvement in penile curvature deformity (P ≤.0008) and sexual function (P <.0001). Significant differences in PD symptom bother and psychological and physical symptoms improvement were found between treatment responders vs nonresponders (P <.02). PDQ penile pain improvement among subjects reporting baseline pain ≥4 was significantly correlated with clinical improvement in sexual function (P ≤.0004) and was found to be greater in treatment responders vs nonresponders (P = .003).
  
  
  CONCLUSIONS
  The utility of the PDQ for monitoring PD-specific psychosexual symptom severity, progression, and treatment response, both clinically and in trials of men with PD, was supported.
authors.affiliation: Department of Urology, Tulane University Health Sciences Center, New Orleans, LA. Electronic address: whellst@tulane.edu.
authors.forename: Wayne J G
authors.initials: WJ
authors.lastname: Hellstrom
authors.affiliation: Connecticut Clinical Research Center and Urology Specialists, Middlebury, CT.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Feldman
authors.affiliation: Evidera, Bethesda, MD.
authors.forename: Karin S
authors.initials: KS
authors.lastname: Coyne
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Kaufman
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: Ted M
authors.initials: TM
authors.lastname: Smith
authors.affiliation: Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
authors.forename: James P
authors.initials: JP
authors.lastname: Tursi
authors.affiliation: New England Research Institutes, Inc., Watertown, MA.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
mesh_terms: D059026:Diagnostic Self Evaluation; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D003012:Microbial Collagenase / Q000627:therapeutic use*; D010411:Penile Induration / Q000175:diagnosis* / Q000188:drug therapy*; D011446:Prospective Studies; D011795:Surveys and Questionnaires
chemical_list: D003012:Microbial Collagenase