Additional Xiaflex

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.

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.

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

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)

out of 40

(study opened Nov 2021 - last updated Oct 2023)