Priapism in Boys and Young Men: Incidence and Prevalence

男孩和年轻男性阴茎异常勃起：发病率和患病率

• 批准号: 7407404
• 负责人: RUPA C REDDING-LALLINGER
• 金额: $ 18.64万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7407404
• 关键词: Accounting; Adhesions; Admission activity; Adolescent; Adult; Adverse effects; Age; Age Distribution; Biological; Blood; Blood flow; Body Composition; Caring; Child; Clinical; Clinical Research; Clinical Trials; Cohort Studies; Complication; Condition; Controlled Clinical Trials; Daily; Data; Development; Double-Blind Method; Drainage procedure; Ejaculation; Emergency Care; Endothelial Cells; Endothelium; Enrollment; Erythrocytes; Etiology; Evaluation; Event; Failure; Frequencies; Functional disorder; Future; Genital system; Goals; Gonadotropins; Growth; Hemoglobin; Hormonal; Hormones; Hypercapnic respiratory failure; Impairment; Impotence; Incidence; Individual; Injury; Inpatients; Intervention Trial; Investigation; Journals; Maintenance; Measurement; Measures; Men' s Role; Methods; Natural History; Nature; Nocturnal Penile Tumescence; Numbers; Observational Study; Orgasm; Outcome Measure; Oxygen; Pain; Participant; Patient Care; Patients; Penile Erection; Phase; Physiological; Pilot Projects; Placebo Control; Placebos; Population; Prevalence; Prevention; Prevention approach; Priapism; Proteins; Pseudoephedrine; Psychological Impact; Psychological adjustment; Puberty; Purpose; Qualifying; Randomized; Rate; Records; Reporting; Risk Factors; Role; Sexual Development; Sickle Cell Anemia; Sleep; Somatomedins; Somatotropin; Source; Staging; Standards of Weights and Measures; Stuttering; Testosterone; Time; Upper arm; Venous; Work; Writing; bone; boys; diaries; disorder later incidence prevention; experience; gonad function; male; men; prepuberty; prevent; prophylactic; prospective; psychologic; sickling; tool; treatment trial; young adult

The primary goal of this study is to conduct a comprehensive investigation of priapism in boys and young men with sickle cell disease (SCD). As such, it represents the initial step toward defining an effective way to manage priapism, and to reduce the frequency of impotence that is its major complication in adult males with SCD. The aims of this proposal are: 1) to conduct a Iongitudinal cohort study in order to define the incidence of priapism in relationship to the physical and hormonal developmental stages of puberty and early maturity, to explore the relationship between priapism and psychological adjustment; and 2) to conduct a pilot, placebo-controlled intervention trial in which the ability of pseudoephedrine to prevent priapism will be evaluated. The first stage of this proposal involves an observational study that will be open to all boys and young men with SCD between the ages of 7 -29 years. They will keep daily records of the occurrence of priapism, and will be admitted every 6 months for an intensive evaluation of physical growth, genital pubertal stage, body composition, bone age, gonadotropins, testosterone, insulin-like growth factor and nocturnal penile tumescence. During these admissions, the participants will also complete several psychological assessments. Data from this phase will be used to identify the association (if any) between priapism and pubertal stage, gonadotropin levels, and testosterone concentration. The data will also determine if there is a relationship between priapism and psychological adjustment. The second stage of this proposal will seek to enroll those individuals who are found to have qualifying episodes of priapism on to a randomized, double-blinded, placebo-controlled clinical trial of pseudoephedrine. The purpose of this pilot study is to determine whether pseudoephedrine is able to prevent episodes of priapism. During this trial, each participant will continue to keep the same daily journal. In addition, each participant will be admitted at the beginning and end of the trial to complete the same physical, hormonal and psychological assessments as were performed in the observational phase. The outcome measures of the prevention trial will be the occurrence of priapism, duration of priapism and the interval between episodes of priapism. In addition, physical growth, secondary sexual development, body composition and psychological adjustment will be compared between the treatment arms. The data collected will establish the feasibility of certain key methods, and will provide estimates of rates, standard deviations, median time-to-event. These results, which are absolutely essential before a large scale treatment trial can be planned, will provide the biological and statistical background for future work in this field.

本研究的主要目的是对患有镰状细胞病（SCD）的男孩和年轻男性阴茎勃起功能障碍进行全面调查。因此，它代表了定义一种有效的方法来管理阴茎勃起，并减少阳痿的频率的第一步，阳痿是成年男性SCD的主要并发症。本研究的目的是：1)通过纵向队列研究，明确阴茎勃起的发生率与青春期和早熟生理和激素发育阶段的关系，探讨阴茎勃起与心理调节的关系；2)进行试点，安慰剂控制