Adding Pelvic CT with Calcium Scoring May Help Urologists Make Treatment Plans for Peyronie Disease

Overview

About this study

Adding a limited noncontrast pelvis CT with Agatston calcium scoring to evaluate and quantify calcified Peyronie plaques can increase the number of patients that qualify for collagenase Clostridium histolyticum (CCH) injection therapy compared with the qualitative assessment by penile duplex Doppler ultrasound (PDDU) and clinical exam.

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:

  • Adult male over 18 years old.
  • Peyronie Disease with stable curvature considered for therapeutic intervention.
  • PDDU obtained at clinic visit.
  • Able to provide informed consent.

Exclusion Criteria: 

  • Implanted penile prosthesis or implanted urethral sphincter that would prevent adequate CT images.
  • Acute active Peyronie disease that would not be managed with injection or surgical therapy.

Eligibility last updated 5/2/22. 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

Jacksonville, Fla.

Mayo Clinic principal investigator

Lauren Alexander, M.D.

Open for enrollment

Contact information:

Kendra Brown M.P.H.

Brown.Kendra@mayo.edu

More information

Publications

  • Peyronie's disease (PD) is a connective tissue disorder of the penis in which a fibrous scar in the tunica albuginea can result in multiple penile deformities. Read More on PubMed
  • Traditionally, diagnosis and treatment plans for Peyronie's disease have been based on history and physical examination. Penile ultrasound provides rapid, anatomical information to establish disease severity, and to monitor progression and response to medical therapy. We determined the relationship between ultrasound characteristics and progression to surgical intervention in men with Peyronie's disease. Read More on PubMed
  • Ultrafast computed tomography was used to detect and quantify coronary artery calcium levels in 584 subjects (mean age 48 +/- 10 years) with (n = 109) and without (n = 475) clinical coronary artery disease. Fifty patients who underwent fluoroscopy and ultrafast computed tomography were also evaluated. Twenty contiguous 3 mm slices were obtained of the proximal coronary arteries. Total calcium scores were calculated based on the number, areas and peak Hounsfield computed tomographic numbers of the calcific lesions detected. In 88 subjects scored by two readers independently, interobserver agreement was excellent with identical total scores obtained in 70. Ultrafast computed tomography was more sensitive than fluoroscopy, detecting coronary calcium in 90% versus 52% of patients. There were significant differences (p less than 0.0001) in mean total calcium scores for those with versus those without clinical coronary artery disease by decade: 5 versus 132, age 30 to 39 years; 27 versus 291, age 40 to 49 years; 83 versus 462, age 50 to 59 years; and 187 versus 786, age 60 to 69 years. Sensitivity, specificity and predictive values for clinical coronary artery disease were calculated for several total calcium scores in each decade. For age groups 40 to 49 and 50 to 59 years, a total score of 50 resulted in a sensitivity of 71% and 74% and a specificity of 91% and 70%, respectively. For age group 60 to 69 years, a total score of 300 gave a sensitivity of 74% and a specificity of 81%. The negative predictive value of a 0 score was 98%, 94% and 100% for age groups 40 to 49, 50 to 59 and 60 to 69 years, respectively. Ultrafast computed tomography is an excellent tool for detecting and quantifying coronary artery calcium. Read More on PubMed