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

Anemia, Sickle Cell Clinical Trial

Official title:

The Epidemiology of Priapism (Sickle Cell Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300235
• Other study ID #: 1319
• Secondary ID: U54HL070587
• Status: Completed
• Start date: August 2005
• Est. completion date: March 2008

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1464
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Priapism

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital at Harvard Medical School	Boston	Massachusetts
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	Children's Hospital Montefiore	Bronx	New York
United States	Montefiore Medical Center and Children's Hospital at Montefiore	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	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 Texas Children's Medical Center of Dallas	Dallas	Texas
United States	University of Texas Parkland Health & Hospital System	Dallas	Texas
United States	University of California, Davis	Davis	California
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	St. Jude Children's Hospital	Memphis	Tennessee
United States	University of South Alabama	Mobile	Alabama
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 Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.	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.	At time of interview
Secondary	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	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.	Cross-sectional single survey visit
Secondary	Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies	Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.	Cross-sectional single survey visit
Secondary	Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol	Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.	Cross-sectional single survey visit