N/A
Completed N=1,459
Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
Priapism · Anemia, Sickle Cell
Source: ClinicalTrials.gov NCT00300235 ↗
Enrolled (actual)
1,459
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia. — 18; 58; 160; 189 participants
Summary
Priapism, a prolonged erection of the penis, is a medical issue that often affects men with sickle cell disease. The purpose of this study is to collect demographic and clinical information on priapism by interviewing men with sickle cell disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia. |
18; 58; 160; 189; 60 | — |
| SECONDARY Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments |
— | — |
| SECONDARY Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies |
— | — |
| SECONDARY Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over OR
- Diagnosis of sickle beta plus thalassemia or sickle hemoglobin C disease, if 15 years of age or over
- Participant and/or parent or guardian must be able to communicate adequately with the interviewer
- May participate if currently taking hydroxyurea, undergoing chronic transfusion, or participating in other research studies, including those involving treatments such as arginine, if all other inclusion criteria are met
Exclusion Criteria
Subjects who meet any of the following criteria are disqualified from enrollment in the study:
- Patient or parent/guardian declines participation.
- Female.
- Subject or parent/guardian unable to communicate adequately with the interviewer.
Data sourced from ClinicalTrials.gov (NCT00300235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.