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

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00300235

Purpose

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.

Condition
Priapism Anemia, Sickle Cell

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	The Epidemiology of Priapism (Sickle Cell Disease)

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
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 ]
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 ]

Enrollment:	1464
Study Start Date:	August 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 200 subjects ages 5 to 9.9 years with a diagnosis of HbSS/HbSβ0
2 400 subjects ages 10 to 14.9 years with a diagnosis of HbSS/HbSβ0
3 400 subjects ages 15 to 24.9 years with a diagnosis of HbSS/HbSβ0
4 400 subjects over the age of 25 with a diagnosis of HbSS/HbSβ0
5 250 subjects age 15 and older with a diagnosis of HbSC or HbSβ+

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.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Males receiving care in any Comprehensive Sickle Cell Center.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300235

Show 27 Study Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

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	Children's Hospital Boston
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

More Information

No publications provided

Responsible Party:	Zora R. Rogers, MD, The University of Texas Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier:	NCT00300235 History of Changes
Other Study ID Numbers:	1319, U54 HL070587
Study First Received:	March 7, 2006
Results First Received:	March 13, 2009
Last Updated:	June 15, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Sickle Cell Anemia

Additional relevant MeSH terms:

Anemia
Anemia, Sickle Cell
Priapism
Hematologic Diseases
Anemia, Hemolytic, Congenital

Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Penile Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 09, 2012