Pelvic CT with Agatston Calcium Score for Peyronie Disease

Mayo Clinic

Status: Completed

Conditions: Peyronie Disease

Treatments: Diagnostic Test: CT exam

Study type: Interventional

Funder types: Other

Identifiers

NCT05480683

22-001770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Targeted CT of pelvis with specific penile anatomical positioning for Peyronie Disease

Experimental group

Description:

Subject presenting with Peyronie disease signs or symptoms to Mayo Clinic Florida Department of Urology will undergo a targeted noncontrast CT of the pelvis with specific penile anatomical positioning

Treatment:

Diagnostic Test: CT exam