Trial Outcomes & Findings for Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence (NCT NCT00300235)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1464 participants

Primary outcome timeframe

At time of interview

Results posted on

2019-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Age 5-9.9 HbSS/HbSβ0 Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0 Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0 Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age >25 HbSS/HbSβ0 Subjects \> 25 yrs w/SCD diagnosis HbSS/HbSβ0	Age >15 HbSC/HbSβ+ Subjects \> 15 yrs w/SCD diagnosis HbSC/HbSβ+
Overall Study STARTED	208	240	398	362	251
Overall Study COMPLETED	208	240	398	362	251
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age 5-9.9 HbSS/HbSβ0 n=208 Participants Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0 n=240 Participants Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0 n=398 Participants Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age >25 HbSS/HbSβ0 n=362 Participants Subjects \> 25 yrs w/SCD diagnosis HbSS/HbSβ0	Age >15 HbSC/HbSβ+ n=251 Participants Subjects \> 15 yrs w/SCD diagnosis HbSC/HbSβ+	Total n=1459 Participants Total of all reporting groups
Age, Categorical <=18 years	208 Participants n=5 Participants	240 Participants n=7 Participants	203 Participants n=5 Participants	0 Participants n=4 Participants	84 Participants n=21 Participants	735 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	195 Participants n=5 Participants	361 Participants n=4 Participants	165 Participants n=21 Participants	721 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants
Age, Continuous	7.4 years STANDARD_DEVIATION 1.44 • n=5 Participants	12.6 years STANDARD_DEVIATION 1.46 • n=7 Participants	19.3 years STANDARD_DEVIATION 2.72 • n=5 Participants	36.0 years STANDARD_DEVIATION 8.93 • n=4 Participants	29.8 years STANDARD_DEVIATION 13.69 • n=21 Participants	22.5 years STANDARD_DEVIATION 12.65 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	240 Participants n=7 Participants	398 Participants n=5 Participants	362 Participants n=4 Participants	251 Participants n=21 Participants	1459 Participants n=10 Participants
Region of Enrollment United States	208 participants n=5 Participants	240 participants n=7 Participants	398 participants n=5 Participants	362 participants n=4 Participants	251 participants n=21 Participants	1459.0 participants n=10 Participants

PRIMARY outcome

Timeframe: At time of interview

Population: All particpants who completed survey were analyzed.

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.

Outcome measures

Outcome measures
Measure	Age 5-9.9 HbSS/HbSβ0 n=208 Participants Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age 10-14.9 HbSS/HbSβ0 n=240 Participants Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0	Age 15-24.9 HbSS/HbSβ0 n=398 Participants Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0	Age >25 HbSS/HbSβ0 n=362 Participants Subjects \> 25 yrs w/SCD diagnosis HbSS/HbSβ0	Age >15 HbSC/HbSβ+ n=251 Participants Subjects \> 15 yrs w/SCD diagnosis HbSC/HbSβ+
Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.	18 participants	58 participants	160 participants	189 participants	60 participants

SECONDARY outcome

Timeframe: Cross-sectional single survey visit

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.