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

• Conditions: Hypospadias

• Registration Number: NCT05032222
• Lead Sponsor: Mohammad Alaa Ezzat

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Status Verified: 2021-09
• Study First Posted: 2021-09-02
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-27
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.	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.	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.	Within 5 years postoperative	Finding correlation between the results of uroflowmetry and HOSE score.

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt