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| ID | Type | Description | Link |
|---|---|---|---|
| U54HL070587 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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+ |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of interview |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
Subjects who meet any of the following criteria are disqualified from enrollment in the study:
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Males receiving care in any Comprehensive Sickle Cell Center.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36688-0002 | United States | ||
| University of California, Davis |
Data still in analysis with NO FUNDING and all on paper from closure of contracted SDMC
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| ID | Title | Description |
|---|---|---|
| FG000 | Age 5-9.9 HbSS/HbSβ0 | Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0 |
| FG001 | Age 10-14.9 HbSS/HbSβ0 | Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | Cross-sectional single survey visit |
| 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 | Boston Children's Hospital | 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 | Study Chair |
| Davis |
| California |
| 95616 |
| United States |
| Children's Hospital and Research Center at Oakland & Summit Medical Center | Oakland | California | 94609 | United States |
| Kaiser Permanente, Oakland | Oakland | California | 94611 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80206 | United States |
| University of Florida | Gainesville | Florida | 32610-0383 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Brigham and Women's Hospital at Harvard Medical School | Boston | Massachusetts | 02115 | United States |
| Children's Hospital of Boston | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Wayne State University | Detroit | Michigan | 48202 | United States |
| Children's Hospital Montefiore | The Bronx | New York | 10467-2940 | United States |
| Montefiore Medical Center and Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| University of Cincinnati Hospital | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| St. Jude Children's Hospital | Memphis | Tennessee | 38105 | United States |
| University of Texas Parkland Health & Hospital System | Dallas | Texas | 75390-8852 | United States |
| University of Texas Children's Medical Center of Dallas | Dallas | Texas | 75390 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| FG002 | Age 15-24.9 HbSS/HbSβ0 | Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0 |
| FG003 | Age >25 HbSS/HbSβ0 | Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0 |
| FG004 | Age >15 HbSC/HbSβ+ | Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+ |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Age 5-9.9 HbSS/HbSβ0 | Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0 |
| BG001 | Age 10-14.9 HbSS/HbSβ0 | Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0 |
| BG002 | Age 15-24.9 HbSS/HbSβ0 | Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0 |
| BG003 | Age >25 HbSS/HbSβ0 | Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0 |
| BG004 | Age >15 HbSC/HbSβ+ | Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+ |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | All particpants who completed survey were analyzed. | Posted | Mar 2009 | Number | participants | At time of interview |
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| Secondary | 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. | Not Posted | Cross-sectional single survey visit | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Cross-sectional single survey visit | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Cross-sectional single survey visit | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age 5-9.9 HbSS/HbSβ0 | Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0 | 0 | 208 | 0 | 208 | ||
| EG001 | Age 10-14.9 HbSS/HbSβ0 | Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0 | 0 | 240 | 0 | 240 | ||
| EG002 | Age 15-24.9 HbSS/HbSβ0 | Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0 | 0 | 398 | 0 | 398 | ||
| EG003 | Age >25 HbSS/HbSβ0 | Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0 | 0 | 362 | 0 | 362 | ||
| EG004 | Age >15 HbSC/HbSβ+ | Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+ | 0 | 251 | 0 | 251 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Kesler, PhD | Rho Federal Systems Division | 919-408-8000 | 244 | karen_kesler@rhoworld.com |
| ID | Term |
|---|---|
| D011317 | Priapism |
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|