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临床试验/NCT05032222
NCT05032222Unknown不适用

The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair

Mohammad Alaa Ezzat1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
105
试验地点
1
主要终点
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.

研究概览

简要总结

Hypospadias is a common anomaly of the male genitalia affecting 0.4-8.2 of 1000 live male babies and varies considerably in severity. The position of the urethral meatus can be classified as anterior or distal (glandular, coronal, or subcoronal; 60-65% of cases), middle (midpenile; 20-30% of cases), or posterior or proximal (posterior penile, penoscrotal, scrotal, or perineal; 10-15% of cases). The subcoronal position is the most common. Most cases are mild and surgical correction is undertaken mostly for cosmetic reasons at the request of the parents or on advice of the pediatrician or surgeon.

Functional success of hypospadias repair depends on the creation of a uniform and adequate caliber urethra up to the meatus. Accordingly, meatal stenosis and urethral stricture are the important complications of surgery, others include urethrocutaneous fistula, diverticula, skin flap necrosis and persistent chordee. Although functional assessment of the repair is possible by observation of the urinary stream and voiding cystourethrography, uroflowmetry is considered to be a more objective tool, especially for the detection of a subclinical urethral stricture. Reports of the results of hypospadias surgery commonly focus on the cosmetic results and incidence of obvious complications, as urethrocutaneous fistulas, and symptomatic urethral Strictures. Few have emphasized the role of uroflowmetry in the postoperative evaluation of children with hypospadias to detect asymptomatic strictures and, despite the simplicity and non-invasive nature of this test, it has not become standard or widely accepted.

We evaluate AUUH experience by use of 'hypospadias objective scoring evaluation' HOSE and uroflowmetry after hypospadias repair. The HOSE is a validated scoring system that incorporates the evaluation of meatal location and shape, urinary stream, straightness of erection, presence and complexity of urethral fistula. The minimum total score is 5, and the maximum total score is 16. The point score is graded as either acceptable or not.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • More than six months after last hypospadias repair.
  • Toilet trained children.
  • Patients less than 18 years old.
  • Successful repair of hypospadias with HOSE score more than 10 decided by one of the experts in pediatric urology.

排除标准

  • Patient not welling to participate in our study.
  • Within six months of last hypospadias repair.
  • Patient had urethral intervention within 3 months.
  • Children with any associated neurological or urological abnormality related to the bladder, which could potentially affect flow pattern.

结局指标

主要结局

Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.

时间窗: Within 5 years post operative

Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.

Number of patients in each Type of the curve of the uroflowmetry.

时间窗: Within 5 years postoperative

Number of patients in each Type of the curve of the uroflowmetry.

Finding correlation between the results of uroflowmetry and HOSE score.

时间窗: Within 5 years postoperative

Finding correlation between the results of uroflowmetry and HOSE score.

次要结局

未报告次要终点

研究者

发起方
Mohammad Alaa Ezzat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad Alaa Ezzat

Resident

Assiut University

研究点 (1)

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