Clinical Trials

Inclusion Criteria:

• ≥ 18  years old.
• 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’:
    • PD symptom duration > 6-months;
    • Stable symptoms > 3-months.
• Patient undergoing intralesional CCH for PD.

Exclusion Criteria:

• Prior intralesional injections or surgery for PD.
• Severe baseline penile pain.
• Moderate or severe baseline ED based on IIEF-EF domain.
• History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
• Ventral or ventrolateral penile curvature.
• Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
• Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/7/23. Questions regarding updates should be directed to the study team contact.