Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie’s Disease

Overview

About this study

The purpose of this study is to investigate the impact of concurrent LiSWT on patient-reported outcomes including symptom bother using the validated Peyronie’s Disease Questionnaire (PDQ) in men undergoing intralesional CCH therapy for Peyronie’s Disease (PD). Also, to o determine whether concurrent LiSWT impacts subjective outcomes including restoration of penetrative sexual intercourse and preventing the need for surgical straightening in men undergoing intralesional CCH for PD, and, to evaluate the impact of LiSWT on erectile function using the International Index of erectile Function, Erectile Function Domain (IIEF-EF).

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tobias Kohler, M.D., M.P.H.

Open for enrollment

Contact information:

Wyatt Anians CCRP

(507) 538-6151

Anians.Wyatt@mayo.edu

More information

Publications

Publications are currently not available