- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300235
Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
The Epidemiology of Priapism (Sickle Cell Disease)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36688-0002
- University of South Alabama
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California
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Davis, California, United States, 95616
- University of California, Davis
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Oakland, California, United States, 94609
- Children's Hospital and Research Center at Oakland & Summit Medical Center
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Oakland, California, United States, 94611
- Kaiser Permanente, Oakland
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80206
- University of Colorado Health Sciences Center
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Florida
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Gainesville, Florida, United States, 32610-0383
- University of Florida
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Kentucky
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Louisville, Kentucky, United States, 40202
- Kosair Children's Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Boston, Massachusetts, United States, 02115
- Children's Hospital of Boston
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital at Harvard Medical School
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Michigan
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Detroit, Michigan, United States, 48202
- Wayne State University
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New York
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Bronx, New York, United States, 10467-2940
- Children's Hospital Montefiore
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Bronx, New York, United States, 10467
- Montefiore Medical Center and Children's Hospital at Montefiore
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati Hospital
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Columbus, Ohio, United States, 43210
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, United States, 19134
- St. Christopher's Hospital for Children
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Hospital
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Texas
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Dallas, Texas, United States, 75390-8852
- University of Texas Parkland Health & Hospital System
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Dallas, Texas, United States, 75390
- University of Texas Children's Medical Center of Dallas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch at Galveston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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1
200 subjects ages 5 to 9.9 years with a diagnosis of HbSS/HbSβ0
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2
400 subjects ages 10 to 14.9 years with a diagnosis of HbSS/HbSβ0
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3
400 subjects ages 15 to 24.9 years with a diagnosis of HbSS/HbSβ0
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4
400 subjects over the age of 25 with a diagnosis of HbSS/HbSβ0
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5
250 subjects age 15 and older with a diagnosis of HbSC or HbSβ+
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.
Time Frame: At time of interview
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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.
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At time of interview
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Cross-sectional single survey visit
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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.
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Cross-sectional single survey visit
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Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies
Time Frame: Cross-sectional single survey visit
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Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.
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Cross-sectional single survey visit
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Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol
Time Frame: Cross-sectional single survey visit
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Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.
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Cross-sectional single survey visit
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Samir Ballas, MD, Thomas Jefferson University
- Study Chair: Lennette Benjamin, Montefiore Medical Center and Children's Hospital of Montefiore
- Study Chair: J. Bessman, MD, University of Texas Southwestern at Galveston
- Study Chair: Joan Cain, MD, UT Children's Hospital of Oklahoma
- Study Chair: Lewis Hsu, MD, St. Christopher's Hospital
- Study Chair: Laura DeCastro, MD, Duke University
- Study Chair: Cage Johnson, MD, University of Southern California Los Angeles County & University of Southern California Medical Center
- Study Chair: Karen Kalinyak, MD, Children's Hospital Medical Center, Cincinnati
- Study Chair: Susan Lieff, PhD, Rho, Inc.
- Study Chair: Lillian McMahon, MD, Boston Medical Center
- Study Chair: William Mentzer, MD, University of California San Francisco Pediatric Hematology/Oncology
- Study Chair: Ashok Raj, MD, Norton Healthcare
- Study Chair: Rupa Redding-Lallinger, MD, University of North Carolina, Chapel Hill
- Study Chair: Zora R. Rogers, MD, University of Texas Southwestern Medical Center at Dallas and Children's Medical Center
- Study Chair: Cynthia Rutherford, MD, University of Texas, Southwestern Medical Center at Dallas
- Study Chair: Kim Smith-Whitley, MD, Children's Hospital of Philadelphia
- Study Chair: Elliott Vichinsky, MD, Children's Hospital and Research Center at Oakland & Summit Medical Center
- Study Chair: Winfred Wang, MD, St. Jude Children's Research Hospital
- Study Chair: Richard Snyder, MD, University of Cincinnati
- Study Chair: Kathryn Hassell, MD, University of Colorado, Denver
- Study Chair: Matthew Heeney, MD, Boston Children's Hospital
- Study Chair: Eric Kraut, MD, Ohio State University
- Study Chair: Stacy Month, MD, Kaiser Permanente - Oakland
- Study Chair: Maureen Okam, MD, Dana-Farber Cancer Institute
- Study Chair: Courtney Thornburg, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1319
- U54HL070587 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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