Peyronie DiseaseNCT05480683
Pelvic CT with Agatston Calcium Score for Peyronie Disease
A study testing CT exam in people with Peyronie Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- CT exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2022to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peyronie Disease with stable curvature considered for therapeutic intervention
- PDDU obtained at clinic visit
- Able to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Pelvic CT with Agatston Calcium Score for Patients with Peyronie Disease May Change Management Decisions in Patients with Calcified Plaque
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.
Read the 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
- Being tested
- CT exam
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT examDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: CT exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: Within 2 weeks of intervention
Secondary outcomes (3)
Calcified plaque number
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The number of calcified plaques (1, 2, 3 or more than 3) will be counted on CT and PDDU.
Measured: Baseline
Calcified plaque length
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be measured in the longest axial and transverse dimensions (mm) on CT and on PDDU.
Measured: Baseline
Calcified plaque continuity
Peyronie plaques with calcification can be identified with noncontrast CT and with PDDU. The plaque will be described as continuous or stippled on CT and PDDU by visual assessment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start4 Aug 2022
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren F. Alexander, Mayo Clinic
- Investigators
- Lauren Alexander, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480683
- Sponsor's protocol ID
- 22-001770
- Status last verified
- Sep 2024
- First submitted
- 25 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Pelvic CT with Agatston Calcium Score for Patients with Peyronie Disease May Change Management Decisions in Patients with Calcified Plaque
- ClinicalTrials.gov ID
- NCT05480683
- Acronym / sponsor ID
- 22-001770
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted CT of pelvis with specific penile anatomical positioning for Peyronie Disease | Experimental | Diagnostic Test: CT examSubject 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peyronie Disease with stable curvature considered for therapeutic intervention
- PDDU obtained at clinic visit
- Able to provide informed consent
Key exclusion criteria (2 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT examNoncontrast CT of the pelvis with specific penile anatomical positioning for coverage and with the protocol optimized for application of Agatston calcium scoring post processing. | Diagnostic test | Targeted CT of pelvis with specific penile anatomical positioning for Peyronie Disease |
Primary outcome
Calcium volume of penile plaques
Time frame: Baseline
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)
Calcium score of penile plaques
Time frame: Baseline
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
Treatment plans adjustment after CT
Time frame: Within 2 weeks of intervention
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.
3 secondary outcomes
Calcified plaque number
Time frame: Baseline
Calcified plaque length
Time frame: Baseline
Calcified plaque continuity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Alexander, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT exam in people with Peyronie Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium volume of penile plaques (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.