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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Zora R. Rogers, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00300235
First received: March 7, 2006
Last updated: October 15, 2013
Last verified: June 2009
  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:


Further study details as provided by University of Texas Southwestern Medical Center:

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 ]
    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.


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 ]
    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.


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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 27 Study Locations
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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, Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00300235     History of Changes
Other Study ID Numbers: 1319, U54HL070587, U54 HL070587
Study First Received: March 7, 2006
Results First Received: March 13, 2009
Last Updated: October 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Sickle Cell Anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Priapism
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Penile Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 18, 2014