Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
Anemia, Sickle Cell
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||The Epidemiology of Priapism (Sickle Cell Disease)|
- Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia. [ Time Frame: At time of interview ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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 [ Time Frame: Cross-sectional single survey visit ] [ Designated as safety issue: No ]Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.
|Study Start Date:||August 2005|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
200 subjects ages 5 to 9.9 years with a diagnosis of HbSS/HbSβ0
400 subjects ages 10 to 14.9 years with a diagnosis of HbSS/HbSβ0
400 subjects ages 15 to 24.9 years with a diagnosis of HbSS/HbSβ0
400 subjects over the age of 25 with a diagnosis of HbSS/HbSβ0
250 subjects age 15 and older with a diagnosis of HbSC or HbSβ+
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300235
Show 27 Study Locations
|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|