Clinical trial NCT00300235: Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
Official title: The Epidemiology of Priapism (Sickle Cell Disease)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Priapism
Anemia, Sickle Cell
Keywords: Sickle Cell Anemia
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-03-08
Enrollment: 1464
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males receiving care in any Comprehensive Sickle Cell 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.

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:

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

Primary outcomes:
measure: Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.
timeFrame: At time of interview
Secondary outcomes:
measure: 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
timeFrame: Cross-sectional single survey visit
measure: Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies
timeFrame: Cross-sectional single survey visit
measure: Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol
timeFrame: Cross-sectional single survey visit
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Oakland
country: United States
facility: Children's Hospital and Research Center at Oakland & Summit Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente, Oakland
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital at Harvard Medical School
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Bronx
country: United States
facility: Children's Hospital Montefiore
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center and Children's Hospital at Montefiore
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Parkland Health & Hospital System
state: Texas
city: Dallas
country: United States
facility: University of Texas Children's Medical Center of Dallas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: Thomas Jefferson University
name: Samir Ballas, MD
role: STUDY_CHAIR
affiliation: Montefiore Medical Center and Children's Hospital of Montefiore
name: Lennette Benjamin
role: STUDY_CHAIR
affiliation: University of Texas Southwestern at Galveston
name: J. Bessman, MD
role: STUDY_CHAIR
affiliation: UT Children's Hospital of Oklahoma
name: Joan Cain, MD
role: STUDY_CHAIR
affiliation: St. Christopher's Hospital
name: Lewis Hsu, MD
role: STUDY_CHAIR
affiliation: Duke University
name: Laura DeCastro, MD
role: STUDY_CHAIR
affiliation: University of Southern California Los Angeles County & University of Southern California Medical Center
name: Cage Johnson, MD
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Karen Kalinyak, MD
role: STUDY_CHAIR
affiliation: Rho, Inc.
name: Susan Lieff, PhD
role: STUDY_CHAIR
affiliation: Boston Medical Center
name: Lillian McMahon, MD
role: STUDY_CHAIR
affiliation: University of California San Francisco Pediatric Hematology/Oncology
name: William Mentzer, MD
role: STUDY_CHAIR
affiliation: Norton Healthcare
name: Ashok Raj, MD
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Rupa Redding-Lallinger, MD
role: STUDY_CHAIR
affiliation: University of Texas Southwestern Medical Center at Dallas and Children's Medical Center
name: Zora R. Rogers, MD
role: STUDY_CHAIR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Cynthia Rutherford, MD
role: STUDY_CHAIR
affiliation: Children's Hospital of Philadelphia
name: Kim Smith-Whitley, MD
role: STUDY_CHAIR
affiliation: Children's Hospital and Research Center at Oakland & Summit Medical Center
name: Elliott Vichinsky, MD
role: STUDY_CHAIR
affiliation: St. Jude Children's Research Hospital
name: Winfred Wang, MD
role: STUDY_CHAIR
affiliation: University of Cincinnati
name: Richard Snyder, MD
role: STUDY_CHAIR
affiliation: University of Colorado, Denver
name: Kathryn Hassell, MD
role: STUDY_CHAIR
affiliation: Boston Children's Hospital
name: Matthew Heeney, MD
role: STUDY_CHAIR
affiliation: Ohio State University
name: Eric Kraut, MD
role: STUDY_CHAIR
affiliation: Kaiser Permanente - Oakland
name: Stacy Month, MD
role: STUDY_CHAIR
affiliation: Dana-Farber Cancer Institute
name: Maureen Okam, MD
role: STUDY_CHAIR
affiliation: Duke University
name: Courtney Thornburg, MD
role: STUDY_CHAIR
References: