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

Sponsor
Mohammad Alaa Ezzat (Other)
Overall Status
Recruiting
CT.gov ID
NCT05032222
Collaborator
(none)
105
Enrollment
1
Location
24
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Uroflowmetry

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
105 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. Finding correlation between the results of uroflowmetry and HOSE score. [Within 5 years postoperative]

    Finding correlation between the results of uroflowmetry and HOSE score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 18 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university hospital Assiut Egypt 11754

Sponsors and Collaborators

  • Mohammad Alaa Ezzat

Investigators

  • Study Director: Hisham M Hammoda, Professor, Assiut University
  • Study Director: Amr H Abo fadan, Lecturer, Assiut University
  • Study Director: Mahmoud F Ali, Lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammad Alaa Ezzat, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05032222
Other Study ID Numbers:
  • Hypospadias repair evaluation
First Posted:
Sep 2, 2021
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypospadias

Study Results

No Results Posted as of Sep 27, 2021