CompletedNCT00300235Updated Feb 1, 2019Results posted

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

An observational study in Priapism and Anemia, Sickle Cell, sponsored by University of Texas Southwestern Medical Center. Completed at 27 sites in United States. Open to male participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 1,464
Ages: 5 Years and older
Sex: Male

Study 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 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 studied

Priapism
Anemia, Sickle Cell

Browse trials for

Anemia, Sickle Cell 1,103

Keywords

Sickle Cell Anemia

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 1,464 is above the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Males receiving care in any Comprehensive Sickle Cell Center.

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

Exclusion Criteria

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 1,464 participants (actual)

Groups and cohorts

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 researchers measure

Primary outcomes

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.
Time frame: At time of interview

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
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
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
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

Posted Aug 3, 2009

Participant flow

Participant flow — Overall Study
Milestone	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+
Started	208	240	398	362	251
Completed	208	240	398	362	251
Not completed	0	0	0	0	0

Outcome measures

PrimaryEnumeration 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.

Time frame:: At time of interview
Reported as:: Number · participants

Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.
participants	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+
Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.	18	58	160	189	60

Statistical analysis

Age 5-9.9 HbSS/HbSβ0 · Proportion of subjects: 35.2 · 95% CI 32.5 to 37.9

SecondaryCharacterization 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.

Time frame:: Cross-sectional single survey visit

Results for this outcome have not been posted.

SecondaryDescriptive 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.

Time frame:: Cross-sectional single survey visit

Results for this outcome have not been posted.

SecondaryAssessment 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.

Time frame:: Cross-sectional single survey visit

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Age 5-9.9 HbSS/HbSβ0	—	0/208 (0%)	0/208 (0%)
Age 10-14.9 HbSS/HbSβ0	—	0/240 (0%)	0/240 (0%)
Age 15-24.9 HbSS/HbSβ0	—	0/398 (0%)	0/398 (0%)
Age >25 HbSS/HbSβ0	—	0/362 (0%)	0/362 (0%)
Age >15 HbSC/HbSβ+	—	0/251 (0%)	0/251 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+	Total
<=18 years	208	240	203	0	84	735
Between 18 and 65 years	0	0	195	361	165	721
>=65 years	0	0	0	1	2	3

Age, Continuous
Age, Continuous(years)	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+	Total
Mean	7.4 ± 1.44	12.6 ± 1.46	19.3 ± 2.72	36.0 ± 8.93	29.8 ± 13.69	22.5 ± 12.65

Sex: Female, Male
Sex: Female, Male(Participants)	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+	Total
Female	0	0	0	0	0	0
Male	208	240	398	362	251	1459

Region of Enrollment
Region of Enrollment(participants)	Age 5-9.9 HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0	Age >25 HbSS/HbSβ0	Age >15 HbSC/HbSβ+	Total
United States	208	240	398	362	251	1459.0

Study locations

27 sites

University of South Alabama
Mobile, Alabama 36688-0002, United States
University of California, Davis
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
Bronx, New York 10467-2940, United States
Montefiore Medical Center and Children's Hospital at Montefiore
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

References and documents

Individual participant data

Plan to share: Undecided — Data still in analysis with NO FUNDING and all on paper from closure of contracted SDMC

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00300235
Lead sponsor: University of Texas Southwestern Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Responsible party: Zora R. Rogers (Professor of Pediatrics, University of Texas Southwestern Medical Center) — Principal investigator
First posted: Mar 8, 2006
Start date: Aug 2005
Primary completion: Mar 2008
Completion: Mar 2008
Results posted: Aug 3, 2009
Last update: Feb 1, 2019

Study contacts

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

Joan Cain, MD

study chair · UT Children's Hospital of Oklahoma

Lewis Hsu, MD

study chair · St. Christopher's Hospital

Laura DeCastro, MD

study chair · Duke University

Cage Johnson, MD

study chair · University of Southern California Los Angeles County & University of Southern California Medical Center

Karen Kalinyak, MD

study chair · Children's Hospital Medical Center, Cincinnati

Susan Lieff, PhD

study chair · Rho, Inc.

Lillian McMahon, MD

study chair · Boston Medical Center

William Mentzer, MD

study chair · University of California San Francisco Pediatric Hematology/Oncology

Ashok Raj, MD

study chair · Norton Healthcare

Rupa Redding-Lallinger, MD

study chair · University of North Carolina, Chapel Hill

Zora R. Rogers, MD

study chair · University of Texas Southwestern Medical Center at Dallas and Children's Medical Center

Cynthia Rutherford, MD

study chair · University of Texas, Southwestern Medical Center at Dallas

Kim Smith-Whitley, MD

study chair · Children's Hospital of Philadelphia

Elliott Vichinsky, MD

study chair · Children's Hospital and Research Center at Oakland & Summit Medical Center

Winfred Wang, MD

study chair · St. Jude Children's Research Hospital

Richard Snyder, MD

study chair · University of Cincinnati

Kathryn Hassell, MD

study chair · University of Colorado, Denver

Matthew Heeney, MD

study chair · Boston Children's Hospital

Eric Kraut, MD

study chair · Ohio State University

Stacy Month, MD

study chair · Kaiser Permanente - Oakland

Maureen Okam, MD

study chair · Dana-Farber Cancer Institute

Courtney Thornburg, MD

study chair · Duke University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Other studies in this condition

Priapism

Other studies from this sponsor

University of Texas Southwestern Medical Center

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

Study summary

Conditions studied

Browse trials for

Keywords

In context

Anemia, Sickle Cell

Lead sponsor

Who can participate

Study population

✓Inclusion criteria

✕Exclusion criteria

Study design

Groups and cohorts

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria