title: Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Patients and Their Female Partners.
abstract: BACKGROUND
  Collagenase Clostridium histolyticum (CCH) intralesional injection was efficacious for the management of Peyronie's disease (PD) in the double-blinded, randomized, placebo-controlled Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and II). Little is known about the consequences of PD or treatment on the sexual partners of affected men.
  
  
  OBJECTIVE
  To assess the safety and efficacy of CCH treatment in men who received placebo in the IMPRESS I or II study and to evaluate the men's PD symptoms and partner bother as reported by female sexual partners.
  
  
  METHODS
  In this phase 3, open-label study (NCT01685437), men (n = 189) received up to eight injections of CCH (0.58 mg/injection). Female sexual partners who provided informed consent at screening (n = 30) participated in the study.
  
  
  METHODS
  Co-primary end points were change or percentage of change in penile curvature deformity and change in PD symptom bother domain score of the Peyronie's Disease Questionnaire (PDQ) from baseline to week 36. Participating women completed the PDQ for female sexual partners (PDQ-FSP) and the Female Sexual Function Index (FSFI).
  
  
  RESULTS
  Statistically significant mean improvements were observed in penile curvature deformity (36.3% decrease; 95% CI = -41.6 to -30.9) and PDQ symptom bother score (2.4-point decrease; 95% CI = -3.0 to -1.8) from baseline to week 36. Most treatment-emergent adverse events were mild or moderate. After CCH treatment of their male partners, female sexual partners reported improvement (using the PDQ-FSP) in their male partner's PD symptoms and female bother regarding their partner's PD. The percentage of female sexual partners with sexual dysfunction (FSFI total score ≤ 26.55) also decreased after male partner treatment, from 75.0% at baseline to 33.3%.
  
  
  CONCLUSIONS
  These results support the safety and efficacy of CCH in the management of appropriate patients with PD and the potential benefits for patients' partners. Goldstein I, Knoll LD, Lipshultz LI, et al. Changes in the Effects of Peyronie's Disease After Treatment With Collagenase Clostridium histolyticum: Male Partners and Their Female Partners. Sex Med 2017;5:e124-e130.
authors.affiliation: Sexual Medicine, Alvarado Hospital, San Diego, CA, USA. Electronic address: dr.irwingoldstein@gmail.com.
authors.forename: Irwin
authors.initials: I
authors.lastname: Goldstein
authors.affiliation: Center for Urological Treatment, Nashville, TN, USA.
authors.forename: L Dean
authors.initials: LD
authors.lastname: Knoll
authors.affiliation: Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Larry I
authors.initials: LI
authors.lastname: Lipshultz
authors.affiliation: Endo Pharmaceuticals, Malvern, PA, USA.
authors.forename: Ted
authors.initials: T
authors.lastname: Smith
authors.affiliation: Auxilium Pharmaceuticals, Malvern, PA, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Kaufman
authors.affiliation: Australian Centre for Sexual Health, St Leonards, NSW, Australia.
authors.forename: Chris G
authors.initials: CG
authors.lastname: McMahon
keywords: Collagenase; Efficacy; Female Sexual Function Index; Peyronie's Disease; Sexual Partners