Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence

Completed

• Conditions: Priapism; Anemia, Sickle Cell

• Registration Number: NCT00300235
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Priapism is a prolonged, painful erection of the penis that lasts for more than four hours and occurs without sexual stimulation. It occurs when blood in the penis becomes trapped and is unable to drain properly. If it is not treated immediately, it can lead to scarring and permanent erectile dysfunction. Many cases of priapism are the result of sickle cell disease; approximately 42% of all adults with sickle cell disease will eventually develop priapism. Current treatments include medication, ice packs, or surgery. More research is needed to better understand the demographic and clinical characteristics of priapism. The purpose of this study is to collect information and further characterize priapism by conducting interviews with men with sickle cell disease. In turn, these findings may guide future priapism clinical trials.

This study will consist of two standardized questionnaires that will be administered to 1,650 men with sickle cell disease. Participants will complete an initial five-item questionnaire about priapism. If a participant indicates past experience with priapism on this initial questionnaire, he will be asked to complete a second questionnaire. This questionnaire will ask in-depth questions to further characterize the participant's episodes of priapism. If health issues such as drug use, harmful sexual behaviors, or impotence are identified upon reviewing the questionnaire, clinic staff will suggest care options and provide appropriate referrals to the participants. All participants will receive an educational brochure about priapism and compensation for completing the questionnaires.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-13
• Results First Submitted QC: 2009-06-15
• Results First Posted: 2009-08-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1464

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:

1. Patient or parent/guardian declines participation.
2. Female.
3. Subject or parent/guardian unable to communicate adequately with the interviewer.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.	At time of interview	Subject responded YES to survey Question "Have you ever had priapism?". By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia.

Secondary Outcome Measures

Name	Time	Method
Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies	Cross-sectional single survey visit	Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.
Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol	Cross-sectional single survey visit	Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.
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	Cross-sectional single survey visit	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.

Trial Locations

Locations (27)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Boston; 🇺🇸 Boston, Massachusetts, United States

University of Cincinnati Hospital; 🇺🇸 Cincinnati, Ohio, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States

University of Texas Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

Children's Hospital and Research Center at Oakland & Summit Medical Center; 🇺🇸 Oakland, California, United States

St. Christopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Brigham and Women's Hospital at Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

Montefiore Medical Center and Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

St. Jude Children's Hospital; 🇺🇸 Memphis, Tennessee, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of California, Davis; 🇺🇸 Davis, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Texas Medical Branch at Galveston; 🇺🇸 Galveston, Texas, United States

Children's Hospital Montefiore; 🇺🇸 Bronx, New York, United States

Kaiser Permanente, Oakland; 🇺🇸 Oakland, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

Kosair Children's Hospital; 🇺🇸 Louisville, Kentucky, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States