Clinical trial NCT05480683: Pelvic CT with Agatston Calcium Score for Peyronie Disease
Official title: Addition of Pelvic CT with Agatston Calcium Score for Patients with Peyronie Disease May Change Management Decisions in Patients with Calcified Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peyronie Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Calcium volume of penile plaques
timeFrame: Baseline
measure: Calcium score of penile plaques
timeFrame: Baseline
measure: Treatment plans adjustment after CT
timeFrame: Within 2 weeks of intervention
Secondary outcomes:
measure: Calcified plaque number
timeFrame: Baseline
measure: Calcified plaque length
timeFrame: Baseline
measure: Calcified plaque continuity
timeFrame: Baseline
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Lauren Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References: