Pelvic CT with Agatston Calcium Score for Peyronie Disease

NCT05480683 | Completed

• 1 other identifier: 22-001770
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (3)

• Calcium volume of penile plaques

  Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to measure the calcium volume (mm3)

  Baseline

• Calcium score of penile plaques

  Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to calculate the Agaston calcium score

  Baseline

• Treatment plans adjustment after CT

  Number of treatment plans to be adjusted after CT results. The treatment options for Peyronie's disease are observation, penile traction therapy, oral medication, medication injection, plaque incision, plaque excision, penile plication with graft, penile plication without graft, penile implant with plaque incision and graft, or penile implant with plication. The study urologist plan will be documented before CT results. After CT results the study urologist will or will not adjust the treatment plan.

  Within 2 weeks of intervention

Secondary Outcomes (3)

• Calcified plaque number

  Baseline

• Calcified plaque length

  Baseline

• Calcified plaque continuity

  Baseline

Study Arms (1)

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

EXPERIMENTAL

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

Diagnostic Test: CT exam

Interventions

CT exam DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peyronie Disease with stable curvature considered for therapeutic intervention
• PDDU obtained at clinic visit
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lauren Alexander, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: August 4, 2022
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)