Orem, Utah 84057

  • Peyronie's Disease

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT04786106


Primary Contact:

Landon Trost, MD
Phone: 888-655-0015
Email: email@peyronies.org


Backup Contact:

N/A


Location Contact:

Orem, Utah 84057
United States

Landon Trost, MD
Phone: 888-655-0015
Email: trost.landon@mfp.clinic

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 17, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.