Surgery vs Xiaflex

Study Objective

  • Currently, there is debate as to whether PD men are ultimately more satisfied with surgery + traction or Xiaflex + traction

  • The objective of the current study is to compare multiple measures of satisfaction among men treated with either surgery or Xiaflex for PD

  • To accomplish this objective, 40 men will be randomized into either surgery + traction or Xiaflex + traction and followed over time to assess satisfaction and other outcomes

Study Details

  • Men wishing to participate will be randomly assigned to either surgery (penile plication or incision/partial excision and grafting) or Xiaflex

  • In-office measurements will be obtained at baseline and at 3 months, 1 year, and 5 years post-op

  • Study questionnaires will be obtained either in person or electronically at baseline, 3, 6, 12, 24, 36, 48, and 60 months

Who May Participate

  • A total of 40 men will be enrolled

  • Must have stable PD (>6 months, no pain, no change in curvature in 3 months)

  • Curvature of at least 30 degrees

  • Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors (e.g. Viagra, Levitra, Cialis, Stendra)

  • No prior treatment with Xiaflex or penile surgery for PD

  • No known penile calcification

Finances and Remuneration

  • Participants in the clinical study will have all study related costs paid for, including the cost of clinical evaluation, penile ultrasound, and treatment (surgery or Xiaflex)

  • Transportation costs will also be reimbursed up to $500 per trip

  • Participants will also be given up to $600 for participation (if completing all visits and questionnaires) and a RestoreX traction device at no cost

  • Funding has been provided by Dr. Landon Trost, who received a grant for the study from Endo Pharmaceuticals (company that manufactures Xiaflex) and donated the full amount to CURE PD

    • The study is being performed independently of Endo Pharmaceuticals (no contributions towards study design, conduct, or reporting)

How Do I Enroll

  • The contracting for transferring the grant funding is currently in process

  • It is anticipated that patients may enroll beginning in August 2020

  • If you are interested in being placed on a wait list for the study, please email us at email@peyronies.org

%

Percentage of Funding Received

out of 40

Number of Patients Enrolled

(study opened Dec 2020 - last updated May 14, 2022)

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