Additional Xiaflex

Study Objective

  • The team at the Male Fertility and Peyronie's Clinic has recently presented data on a novel method of administering Xiaflex which results in improved outcomes compared to traditional approaches. 

  • The objective of the current study is to evaluate whether the new administration technique may achieve benefits in men who have previously undergone 6-8 Xiaflex injections with a <20% curve improvement with their prior Xiaflex injections. 

  • To accomplish this objective, 40 men will be randomized into either control (x 6 months, followed by Xiaflex) or up front Xiaflex.

Study Details

  • Men wishing to participate will be randomly assigned to either Xiaflex or control.  The Xiaflex men will receive up to 8 Xiaflex injections, followed by a period of observation.  The control men will receive no treatment for 6 months, followed by up to 8 Xiaflex injections. 

  • In-office measurements and questionnaires will be obtained at baseline, 6 weeks after completing Xiaflex, and at the end of the no treatment phase. 

  • Men will be randomized using pre-stratified tables based on initial penile curvature.

Who May Participate

  • A total of 40 men will be enrolled

  • Must have PD and completed 6-8 Xiaflex injections without >20% or >10 degree improvements

  • Curvature >30 degrees

  • Prior injections must have been done without use of RestoreX

  • Baseline erectile function must be sufficient for intercourse without PDE5 inhibitors

Finances and Remuneration

  • Participants in the clinical study will be reimbursed for personal costs, including the cost of clinical evaluation, penile ultrasound, and treatment (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)

How Do I Enroll

%

Percentage of Study Funding Received

out of 40

Number of Patients Enrolled

(study opened Nov 2021 - last updated July 2022)

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