PriapismMARSNCT04932902
ManAgement of pRiapiSm and Its Impact on Outcomes
An observational study of Priapism, run by Policlinic Hospital "G. Rodolico" at 5 sites in 2 countries.
Trial summary
Priapism is a urological emergency that is defined as a prolonged penile erection lasting more than 4 h, remaining despite orgasm and in the absence of sexual stimulation. There are three sub-types of priapism: Ischaemic, non- ischaemic and stuttering. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Priapism
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jun 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with priapism: ischemic, non-ischemic or stuttered.
Who may be able to join
- Patients with Priapism
Who cannot join
- None
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Italy4 sites
Giorgio Ivan Russo
Catania, CT, 95123
University of Florence
Florence
University of Torino
Torino
University of Varese
Varese
Portugal1 site
Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal
Porto
About this study
Official title: ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register
Priapism is a urological emergency that is defined as a prolonged penile erection lasting more than 4 h, remaining despite orgasm and in the absence of sexual stimulation. There are three sub-types of priapism: Ischaemic, non- ischaemic and stuttering. The most common (95% cases) of these is ischaemic priapism (IP), which represents a compartment syndrome of the corpus cavernosa with minimal or no arterial flow into the penis. It causes time-dependent smooth muscle damage that can result in significant morbidity (including, permanent erectile dysfunction (ED), penile shortening, penile curvature and loss of girth) with- out prompt intervention.
Unlike ischemic priapism, non-ischemic priapism is not a urologic emergency, both the American Urological Association (AUA) and the European Association of Urology (EAU) recommend conservative, non-operative, management for the treatment of NIP. Spontaneous resolution has been documented to occur in 62% of patients [1].
Read more
Despite the very high burden of priapism and its time-dependent adverse effect on erectile function, few studies have comprehensively defined the clinical epidemiology of this complication nor have any compared sexual dysfunction in men with SCD with that in those without it. Evidence-based treatment strategies for priapism are currently lacking, especially in terms of sexual function.
However, despite the various publications in the literature, even today the published studies show considerable bias, in terms of sample size, evaluation of reproducible outcomes, use of internationally validated questionnaires, well-defined follow-up evaluation, as well as the evaluation of outcome after medical or surgical treatment. For this reason, the purpose of this international register is precisely to shed light on what may be the responses to medical surgical treatment in patients with priapism, but in particular to set up a rational data collection that has solid scientific bases.
Read the detailed description
Aims and objectives
Based on the previous premises, the aim of our study is to evaluate the impact of the management of priapism from a sexual and clinical long-term outcomes point of view.
Sexual outcomes will be assessed by measured questionnaire (e.g. IIEF-15) at 3-6 months after priapism.
Clinical outcomes will be registered as rates of resolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode), corporal injury (fibrosis or necrosis), adverse events including erectile dysfunction, penile curvature/Peyronie's disease, requirement for surgical management of priapism.
Sample size calculation
Since the study is designed as a prospective data collection through a registry, and since there are no comparative analyses between different groups, it is not possible to identify a priori sample size. However, considering that the largest case history on the field of priapism amounts to a total of 112 patients [3], we believe that collecting data from a total of 200 patients is sufficient in order to obtain scientifically reliable results with a high scientific profile.
- Conditions
- Priapism
- Medical subject headings
- Priapism
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-5 at 3 months
Sexual function as reported by patient or measured by questionnaire
Measured: 3 months
Secondary outcomes (4)
IIEF-5 at 6 months
Sexual function as reported by patient or measured by questionnaire
Measured: 6 months
Requirement for surgical management of priapism
Requirement for surgical management of priapism
Measured: Within 1 month
Adverse events including erectile dysfunction, penile curvature/Peyronie's disease
Adverse events
Measured: 6 months
Resolution
Resolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PriapismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinic Hospital "G. Rodolico"
- Sponsor type
- University, hospital or other
- Collaborators
- European Association of Urology Research Foundation
- Responsible party
- Principal investigator, Giorgio Ivan Russo, Policlinic Hospital "G. Rodolico"
- Investigators
- Giorgio Ivan Russo, MD, Principal investigator, Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932902
- Sponsor's protocol ID
- 122/2021
- Acronym
- MARS
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2021
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register
- ClinicalTrials.gov ID
- NCT04932902
- Acronym / sponsor ID
- MARS / 122/2021
- Conditions
- Priapism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Policlinic Hospital "G. Rodolico"University, hospital or other
- Collaborators
- European Association of Urology Research Foundation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jun 2021 (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.
Priapism is a urological emergency that is defined as a prolonged penile erection lasting more than 4 h, remaining despite orgasm and in the absence of sexual stimulation. There are three sub-types of priapism: Ischaemic, non- ischaemic and stuttering. The most common (95% cases) of these is ischaemic priapism (IP), which represents a compartment syndrome of the corpus cavernosa with minimal or no arterial flow into the penis. It causes time-dependent smooth muscle damage that can result in significant morbidity (including, permanent erectile dysfunction (ED), penile shortening, penile curvature and loss of girth) with- out prompt intervention.
Unlike ischemic priapism, non-ischemic priapism is not a urologic emergency, both the American Urological Association (AUA) and the European Association of Urology (EAU) recommend conservative, non-operative, management for the treatment of NIP. Spontaneous resolution has been documented to occur in 62% of patients [1].
Despite the very high burden of priapism and its time-dependent adverse effect on erectile function, few studies have comprehensively defined the clinical epidemiology of this complication nor have any compared sexual dysfunction in men with SCD with that in those without it. Evidence-based treatment strategies for priapism are currently lacking, especially in terms of sexual function.
However, despite the various publications in the literature, even today the published studies show considerable bias, in terms of sample size, evaluation of reproducible outcomes, use of internationally validated questionnaires, well-defined follow-up evaluation, as well as the evaluation of outcome after medical or surgical treatment. For this reason, the purpose of this international register is precisely to shed light on what may be the responses to medical surgical treatment in patients with priapism, but in particular to set up a rational data collection that has solid scientific bases.
Detailed description
Aims and objectives
Based on the previous premises, the aim of our study is to evaluate the impact of the management of priapism from a sexual and clinical long-term outcomes point of view.
Sexual outcomes will be assessed by measured questionnaire (e.g. IIEF-15) at 3-6 months after priapism.
Clinical outcomes will be registered as rates of resolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode), corporal injury (fibrosis or necrosis), adverse events including erectile dysfunction, penile curvature/Peyronie's disease, requirement for surgical management of priapism.
Sample size calculation
Since the study is designed as a prospective data collection through a registry, and since there are no comparative analyses between different groups, it is not possible to identify a priori sample size. However, considering that the largest case history on the field of priapism amounts to a total of 112 patients [3], we believe that collecting data from a total of 200 patients is sufficient in order to obtain scientifically reliable results with a high scientific profile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with priapism: ischemic, non-ischemic or stuttered.
Key inclusion criteria (1 listed)
- Patients with Priapism
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IIEF-5 at 3 months
Time frame: 3 months
Sexual function as reported by patient or measured by questionnaire
4 secondary outcomes
IIEF-5 at 6 months
Time frame: 6 months
Requirement for surgical management of priapism
Time frame: Within 1 month
Adverse events including erectile dysfunction, penile curvature/Peyronie's disease
Time frame: 6 months
Resolution
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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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.
Giorgio Ivan Russo, MD principal investigator
Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Priapism, run by Policlinic Hospital "G. Rodolico" at 5 sites in 2 countries.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Portugal. 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?
This study is still under way. Results are not available in the source record yet.
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?
IIEF-5 at 3 months (time frame: 3 months). 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 1 Aug 2025.