NCT05480683

Pelvic CT with Agatston Calcium Score for Peyronie Disease

Addition of Pelvic CT with Agatston Calcium Score for Patients with Peyronie Disease May Change Management Decisions in Patients with Calcified Plaque

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out how including a CT exam of the penis can help urologists make treatment decisions for patients with calcified Peyronie's disease.

Detailed description

Peyronie disease (PD) affects up to 10% of men with fibrosing penile plaques causing penile pain and progressing to deformity. Calcified plaque develops in up to 20% of these patients, excluding them from medical therapy with collagenase injection and often requiring more extensive surgery for treatment. PDDU identifies plaque distribution and characteristics while the Doppler exam evaluates for any underlying erectile dysfunction. Calcification can make PDDU difficult to identify the full extent of plaque since the shadow caused by calcification may prevent accurate measurement and over or underestimate the plaque size. In addition, the ultrasound exam is operator dependent and requires injection of an agent to induce erection. Since current clinical practice excludes men with any degree of calcification presumed on physical examination or demonstrated on PDDU from receiving injection therapy they may be triaged to surgical management instead. A prior study found the presence of calcifications at ultrasound had odd ratio 1.75 of patient progressing to surgical management, while fibrosis without calcification did not have increased odds of surgical management. Noncontrast pelvis CT provides three dimensional detail of calcified plaque including parts of the penis that are difficult to image with PDDU, and calcification does not have artifact on CT. By adding non-contrast pelvis CT with Agatston calcium scoring to PDDU and clinical parameters of penile deformity, patients may be better stratified into the appropriate treatment pathway.

Conditions

• Peyronie Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT exam	Noncontrast CT of the pelvis with specific penile anatomical positioning for coverage and with the protocol optimized for application of Agatston calcium scoring post processing.

Timeline

• Start date: 2022-08-04
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2022-07-29
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States