The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Intralesional injection
Delivers low-intensity shockwave therapy, six sessions (once/week) of 2000 shockwaves per session with a constant energy flux density of 0.29 mJ/mm2 and frequency of 3 Hz
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in penile curvature
Measured with a goniometer after artificial erection reported in degree unit of measurements
Time frame: Baseline, 10 weeks
Change in Sexual function
Measured using the Sexual Encounter Profile (SEP) questions 2 and 3 to assess functional outcomes on a scale of 0=no sexual activity/did not attempt intercourse; 1=almost never/never; 2=A few times (much less than half the time); 3=Sometimes (about half the time); 4=Most times (much more than half the time); 5=Almost always/always
Time frame: Baseline, 10 weeks
Change in penile length
Time frame: Baseline, 10 weeks
Li-SWL related pain at therapy sessions
Measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain)
Time frame: 6 weeks
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