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

The University of Texas System (UT)

Status: Completed

Conditions: Priapism; Anemia, Sickle Cell

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00300235

1319

U54HL070587 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,464 patients

Sex: Male

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,464 participants in 5 patient groups

1

Description:

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

2

Description:

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

3

Description:

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

4

Description:

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

5

Description:

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