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

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

Status and phase: Active, not recruiting; Phase 4

Conditions: Peyronie's Disease

Treatments: Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH); Procedure: Incision and Grafting (I&G) Surgery; Device: RestoreX Penile Traction Device; Procedure: Penile Plication Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04786106

CUREPD101

Details and patient eligibility

About

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.

Full description

After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men with PD
• >18 years old
• Curvature ≥30 degrees
• Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors

Exclusion criteria

• Prior treatment with CCH or surgery
• Moderate (shadowing) or severe (>1 cm) penile calcification
• Any contraindications to CCH, PTT, or surgery - as determined by the PI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

CCH+PTT

Active Comparator group

Description:

Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit.

Treatment:

Device: RestoreX Penile Traction Device

Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)

Surgery+PTT

Active Comparator group

Description:

Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit.

Treatment:

Procedure: Penile Plication Surgery

Device: RestoreX Penile Traction Device

Procedure: Incision and Grafting (I&G) Surgery