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

NCT ID: NCT00300235

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1464 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-03-31

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.

Conditions

Priapism; Anemia, Sickle Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

200 subjects ages 5 to 9.9 years with a diagnosis of HbSS/HbSβ0

No interventions assigned to this group

2

400 subjects ages 10 to 14.9 years with a diagnosis of HbSS/HbSβ0

No interventions assigned to this group

3

400 subjects ages 15 to 24.9 years with a diagnosis of HbSS/HbSβ0

No interventions assigned to this group

4

400 subjects over the age of 25 with a diagnosis of HbSS/HbSβ0

No interventions assigned to this group

5

250 subjects age 15 and older with a diagnosis of HbSC or HbSβ+

No interventions assigned to this group

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

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zora R. Rogers

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samir Ballas, MD

Role: STUDY_CHAIR

Thomas Jefferson University

Lennette Benjamin

Role: STUDY_CHAIR

Montefiore Medical Center and Children's Hospital of Montefiore

J. Bessman, MD

Role: STUDY_CHAIR

University of Texas Southwestern at Galveston

Joan Cain, MD

Role: STUDY_CHAIR

UT Children's Hospital of Oklahoma

Lewis Hsu, MD

Role: STUDY_CHAIR

St. Christopher's Hospital

Laura DeCastro, MD

Role: STUDY_CHAIR

Duke University

Cage Johnson, MD

Role: STUDY_CHAIR

University of Southern California Los Angeles County & University of Southern California Medical Center

Karen Kalinyak, MD

Role: STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Susan Lieff, PhD

Role: STUDY_CHAIR

Rho, Inc.

Lillian McMahon, MD

Role: STUDY_CHAIR

Boston Medical Center

William Mentzer, MD

Role: STUDY_CHAIR

University of California San Francisco Pediatric Hematology/Oncology

Ashok Raj, MD

Role: STUDY_CHAIR

Norton Healthcare

Rupa Redding-Lallinger, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Zora R. Rogers, MD

Role: STUDY_CHAIR

University of Texas Southwestern Medical Center at Dallas and Children's Medical Center

Cynthia Rutherford, MD

Role: STUDY_CHAIR

University of Texas, Southwestern Medical Center at Dallas

Kim Smith-Whitley, MD

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Elliott Vichinsky, MD

Role: STUDY_CHAIR

Children's Hospital and Research Center at Oakland & Summit Medical Center

Winfred Wang, MD

Role: STUDY_CHAIR

St. Jude Children's Research Hospital

Richard Snyder, MD

Role: STUDY_CHAIR

University of Cincinnati

Kathryn Hassell, MD

Role: STUDY_CHAIR

University of Colorado, Denver

Matthew Heeney, MD

Role: STUDY_CHAIR

Boston Children's Hospital

Eric Kraut, MD

Role: STUDY_CHAIR

Ohio State University

Stacy Month, MD

Role: STUDY_CHAIR

Kaiser Permanente - Oakland

Maureen Okam, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Courtney Thornburg, MD

Role: STUDY_CHAIR

Duke University

Locations

University of South Alabama

Mobile, Alabama, United States

University of California, Davis

Davis, California, United States

Children's Hospital and Research Center at Oakland & Summit Medical Center

Oakland, California, 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

University of Florida

Gainesville, Florida, United States

Kosair Children's Hospital

Louisville, Kentucky, United States

Brigham and Women's Hospital at Harvard Medical School

Boston, Massachusetts, United States

Children's Hospital of Boston

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Children's Hospital Montefiore

The Bronx, New York, United States

Montefiore Medical Center and Children's Hospital at Montefiore

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Hospital

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

St. Jude Children's Hospital

Memphis, Tennessee, 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

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Countries

United States

Other Identifiers

U54HL070587

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1319

Identifier Type: -

Identifier Source: org_study_id