Clinical trial NCT05032222: The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Official title: The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 105
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non probability sample size) with Confidence Level 90 % , Population Size 10000 , Margin of Error 8 % with expected size of 105 patients starting from 01/04/2021 to 1/04/2022.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients show Change of the maximum flow rate, average flow rate (Qav), total voided volume, PMR and voiding time from normal values.
timeFrame: Within 5 years post operative
measure: Number of patients in each Type of the curve of the uroflowmetry.
timeFrame: Within 5 years postoperative
measure: Finding correlation between the results of uroflowmetry and HOSE score.
timeFrame: Within 5 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Hisham M Hammoda, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Amr H Abo fadan, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mahmoud F Ali, Lecturer
role: STUDY_DIRECTOR
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