Mayo Clinic
The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.
Inclusion Criteria • Diagnosed with PD * Palpable penile plaque * Dorsal, lateral, or dorsolateral penile curvature * Penile curvature \> 30 degrees and \< 90 degrees as measured using goniometer during objective curvature assessment * Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU) * "Stable PD symptoms' defined as PD symptom duration \> 6-months or stable symptoms \> 3-months Exclusion Criteria: * Prior intralesional injections or surgery for PD. * Severe baseline penile pain. * Moderate or severe baseline…
Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.
Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series.
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