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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Epidemiology of Priapism (Sickle Cell Disease)

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 Summary:

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.

Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia. [ Time Frame: At time of interview ]

Original Primary Outcome:

Current Secondary Outcome:

• 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 ]
  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 ]
  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 ]
  Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.

Original Secondary Outcome:

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: March 7, 2006
Date Started: August 2005
Date Completion:
Last Updated: December 22, 2015
Last Verified: December 2015