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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Mayo Clinic Minnesota
Rochester, Minnesota, United States
RECRUITINGChange in symptom bother
Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"
Time frame: Baseline, 6 weeks
Change in penetrative sexual intercourse
Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.
Time frame: Baseline, 6 weeks
Surgical straightening intervention
Number of subjects to require surgical straightening
Time frame: 6 weeks
Change in erectile function
Measured using the International Index of erectile Function
Time frame: Baseline, 6 weeks
Change in Erectile Function Domain (IIEF-EF)
Time frame: Baseline, 6 weeks
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