Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 30, 2020

Primary Completion Date

February 15, 2027

Study Completion Date

February 15, 2027

Conditions
Peyronie's Disease
Interventions
DRUG

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.

PROCEDURE

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.

PROCEDURE

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.

DEVICE

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.

Trial Locations (1)

84057

The Male Fertility and Peyronie's Clinic, Orem

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Endo Pharmaceuticals

INDUSTRY

lead

Charitable Union for the Research and Education of Peyronie's Disease

OTHER