Clinical Research Directory
Browse clinical research sites, groups, and studies.
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Sponsor: Charitable Union for the Research and Education of Peyronie's Disease
Summary
The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.
Official title: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2020-12-30
Completion Date
2027-02-15
Last Updated
2025-02-13
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
The Male Fertility and Peyronie's Clinic
Orem, Utah, United States