PriapismNCT00300235
Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence
An observational study of Priapism and Anemia, Sickle Cell, run by University of Texas Southwestern Medical Center at 27 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older, men only
- Conditions the study is for
- Priapism, Anemia, Sickle Cell
- How many people
- 1,464 participants
- Where
- 27 sitesUnited States
- Study dates
- Aug 2005to Mar 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males receiving care in any Comprehensive Sickle Cell Center.
Who may be able to join
- 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
Who cannot join
- Subjects who meet any of the following criteria are disqualified from enrollment in the study:
- Patient or parent/guardian declines participation.
- Female.
- Subject or parent/guardian unable to communicate adequately with the interviewer.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Brigham and Women's Hospital at Harvard Medical School
Boston, Massachusetts, 02115
Children's Hospital of Boston
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Cincinnati Hospital
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
University of Texas Parkland Health & Hospital System
Dallas, Texas, 75390-8852
University of Texas Children's Medical Center of Dallas
Dallas, Texas, 75390
University of California, Davis
Davis, California, 95616
University of Colorado Health Sciences Center
Denver, Colorado, 80206
Wayne State University
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610-0383
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Kosair Children's Hospital
Louisville, Kentucky, 40202
St. Jude Children's Hospital
Memphis, Tennessee, 38105
University of South Alabama
Mobile, Alabama, 36688-0002
Children's Hospital and Research Center at Oakland & Summit Medical Center
Oakland, California, 94609
Kaiser Permanente, Oakland
Oakland, California, 94611
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
University of California, San Francisco
San Francisco, California, 94143
Children's Hospital Montefiore
The Bronx, New York, 10467-2940
Montefiore Medical Center and Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: The Epidemiology of Priapism (Sickle Cell Disease)
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.
Read the 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.
- Conditions
- Priapism, Anemia, Sickle Cell
- Keywords
- Sickle Cell Anemia
- Medical subject headings
- Priapism, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of interview
Secondary outcomes (3)
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.
Measured: 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
Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.
Measured: 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
Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.
Measured: Cross-sectional single survey visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startAug 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PriapismStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Zora R. Rogers, University of Texas Southwestern Medical Center
- Investigators
- Samir Ballas, MD, Study chair, Thomas Jefferson UniversityLennette Benjamin, Study chair, Montefiore Medical Center and Children's Hospital of MontefioreJ. Bessman, MD, Study chair, University of Texas Southwestern at GalvestonJoan Cain, MD, Study chair, UT Children's Hospital of OklahomaLewis Hsu, MD, Study chair, St. Christopher's HospitalLaura DeCastro, MD, Study chair, Duke UniversityCage Johnson, MD, Study chair, University of Southern California Los Angeles County & University of Southern California Medical CenterKaren Kalinyak, MD, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300235
- Sponsor's protocol ID
- 1319
- Other IDs
- U54HL070587
- Status last verified
- Jan 2019
- First submitted
- 7 Mar 2006
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data still in analysis with NO FUNDING and all on paper from closure of contracted SDMC
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Priapism (Sickle Cell Disease)
- ClinicalTrials.gov ID
- NCT00300235
- Acronym / sponsor ID
- 1319
- Conditions
- Priapism, Anemia, Sickle Cell
- Keywords
- Sickle Cell Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Mar 2006 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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+ |
Who may qualify
- Ages
- 5 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males receiving care in any Comprehensive Sickle Cell Center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Subjects who meet any of the following criteria are disqualified from enrollment in the study:
- Patient or parent/guardian declines participation.
- Female.
- Subject or parent/guardian unable to communicate adequately with the interviewer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data still in analysis with NO FUNDING and all on paper from closure of contracted SDMC
Related trials for Priapism
Active, not recruiting
Lipid Balance in Adult Sickle Cell Patients
Sickle Cell Disease, Dyslipidemia
Enrolling by invitationObservational study
ManAgement of pRiapiSm and Its Impact on Outcomes
Priapism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Ballas, MD study chair
Thomas Jefferson University
Lennette Benjamin study chair
Montefiore Medical Center and Children's Hospital of Montefiore
J. Bessman, MD study chair
University of Texas Southwestern at Galveston
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Priapism and Anemia, Sickle Cell, run by University of Texas Southwestern Medical Center at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia. (time frame: At time of interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.