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

Wayne J G Hellstrom; Robert A Feldman; Karin S Coyne; Gregory J Kaufman; Ted M Smith; James P Tursi; Raymond C Rosen

doi:10.1016/j.urology.2015.04.047

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

Urology. 2015 Aug;86(2):291-8. doi: 10.1016/j.urology.2015.04.047. Epub 2015 Jul 18.

Authors

Wayne J G Hellstrom¹, Robert A Feldman², Karin S Coyne³, Gregory J Kaufman⁴, Ted M Smith⁴, James P Tursi⁴, Raymond C Rosen⁵

Affiliations

¹ Department of Urology, Tulane University Health Sciences Center, New Orleans, LA. Electronic address: whellst@tulane.edu.
² Connecticut Clinical Research Center and Urology Specialists, Middlebury, CT.
³ Evidera, Bethesda, MD.
⁴ Auxilium Pharmaceuticals, Inc., Chesterbrook, PA.
⁵ New England Research Institutes, Inc., Watertown, MA.

PMID: 26199168
DOI: 10.1016/j.urology.2015.04.047

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.

Materials and 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).

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT01221597 NCT01221623.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Diagnostic Self Evaluation*
Double-Blind Method
Humans
Male
Microbial Collagenase / therapeutic use*
Penile Induration / diagnosis*
Penile Induration / drug therapy*
Prospective Studies
Surveys and Questionnaires*

Substances

Microbial Collagenase

Associated data

ClinicalTrials.gov/NCT01221597
ClinicalTrials.gov/NCT01221623