Surgery vs Xiaflex
Study Objective
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Currently, there is debate as to whether PD men are ultimately more satisfied with surgery + traction or Xiaflex + traction
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The objective of the current study is to compare multiple measures of satisfaction among men treated with either surgery or Xiaflex for PD
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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
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Men wishing to participate will be randomly assigned to either surgery (penile plication or incision/partial excision and grafting) or Xiaflex
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In-office measurements will be obtained at baseline and at 3 months, 1 year, and 5 years post-op
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Study questionnaires will be obtained either in person or electronically at baseline, 3, 6, 12, 24, 36, 48, and 60 months
Who May Participate
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A total of 40 men will be enrolled
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Must have stable PD (>6 months, no pain, no change in curvature in 3 months)
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Curvature of at least 30 degrees
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Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors (e.g. Viagra, Levitra, Cialis, Stendra)
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No prior treatment with Xiaflex or penile surgery for PD
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No known penile calcification
Finances and Remuneration
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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)
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Transportation costs will also be reimbursed up to $500 per trip
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Participants will also be given up to $600 for participation (if completing all visits and questionnaires) and a RestoreX traction device at no cost
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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
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The study is being performed independently of Endo Pharmaceuticals (no contributions towards study design, conduct, or reporting)
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How Do I Enroll
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The contracting for transferring the grant funding is currently in process
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It is anticipated that patients may enroll beginning in August 2020
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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)