40
Participants
Start Date
December 30, 2020
Primary Completion Date
February 15, 2027
Study Completion Date
February 15, 2027
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
Men in this cohort would receive the full series of 8 Xiaflex injections: 2 injections separated by 1-3 days, repeated 3 additional times with 6 week breaks between treatments.
Penile Plication Surgery
Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures \<70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.
Incision and Grafting (I&G) Surgery
Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures \<70 degrees; I\&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I\&G) will ultimately be decided based on the primary investigator's clinical judgment.
RestoreX Penile Traction Device
RestoreX is a Class I PTT device developed by PathRight Medical, is registered with the FDA, and has randomized controlled data demonstrating efficacy when used for the treatment of PD.
The Male Fertility and Peyronie's Clinic, Orem
Collaborators (1)
Endo Pharmaceuticals
INDUSTRY
Charitable Union for the Research and Education of Peyronie's Disease
OTHER