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出境医 / 临床实验 / ManAgement of pRiapiSm and Its Impact on Outcomes (MARS)

ManAgement of pRiapiSm and Its Impact on Outcomes (MARS)

Study Description
Brief 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. 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.


Condition or disease
Priapism

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. IIEF-5 at 3 months [ Time Frame: 3 months ]
    Sexual function as reported by patient or measured by questionnaire


Secondary Outcome Measures :
  1. IIEF-5 at 6 months [ Time Frame: 6 months ]
    Sexual function as reported by patient or measured by questionnaire

  2. Requirement for surgical management of priapism [ Time Frame: Within 1 month ]
    Requirement for surgical management of priapism

  3. Adverse events including erectile dysfunction, penile curvature/Peyronie's disease [ Time Frame: 6 months ]
    Adverse events

  4. Resolution [ Time Frame: 30 minutes ]
    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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with priapism: ischemic, non-ischemic or stuttered.
Criteria

Inclusion Criteria:

  • Patients with Priapism

Exclusion Criteria:

  • None
Contacts and Locations

Locations
Layout table for location information
Italy
Giorgio Ivan Russo
Catania, CT, Italy, 95123
University of Florence
Florence, Italy
University of Torino
Torino, Italy
University of Varese
Varese, Italy
Portugal
Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal
Porto, Portugal
Sponsors and Collaborators
Policlinic Hospital "G. Rodolico"
European Association of Urology Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Giorgio Ivan Russo, MD Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico
Tracking Information
First Submitted Date June 13, 2021
First Posted Date June 21, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date June 1, 2021
Actual Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2021)
IIEF-5 at 3 months [ Time Frame: 3 months ]
Sexual function as reported by patient or measured by questionnaire
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2021)
  • IIEF-5 at 6 months [ Time Frame: 6 months ]
    Sexual function as reported by patient or measured by questionnaire
  • Requirement for surgical management of priapism [ Time Frame: Within 1 month ]
    Requirement for surgical management of priapism
  • Adverse events including erectile dysfunction, penile curvature/Peyronie's disease [ Time Frame: 6 months ]
    Adverse events
  • Resolution [ Time Frame: 30 minutes ]
    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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ManAgement of pRiapiSm and Its Impact on Outcomes
Official Title ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with priapism: ischemic, non-ischemic or stuttered.
Condition Priapism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 13, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2023
Actual Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Priapism

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT04932902
Other Study ID Numbers 122/2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Giorgio Ivan Russo, Policlinic Hospital "G. Rodolico"
Study Sponsor Policlinic Hospital "G. Rodolico"
Collaborators European Association of Urology Research Foundation
Investigators
Principal Investigator: Giorgio Ivan Russo, MD Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico
PRS Account Policlinic Hospital "G. Rodolico"
Verification Date September 2021