Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00300235
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2006-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
The Epidemiology of Priapism (Sickle Cell Disease)
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U54HL070587 | NIH | None | https://reporter.nih.gov/quic… | View |