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

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032222
• Other study ID #: Hypospadias repair evaluation
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Mohamad A Ezzat, Resident
• Phone: +201125035035
• Email: mohamed.20134296[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypospadias

Intervention

Other:
• Uroflowmetry
Diagnostic test

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Alaa Ezzat

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Eassa W, Brzezinski A, Capolicchio JP, Jednak R, El-Sherbiny M. How do asymptomatic toilet-trained children void following tubularized incised-plate hypospadias repair? Can Urol Assoc J. 2012 Aug;6(4):238-42. doi: 10.5489/cuaj.12029. — View Citation

Garignon C, Chamond C, Lefébure B, Halim Y, Mitrofanoff P, Liard A. [Uroflowmetric functional evaluation of modified Duplay procedure in hypospadias surgery]. Prog Urol. 2004 Dec;14(6):1199-202; discussion 1202. French. — View Citation

González R, Ludwikowski BM. Importance of urinary flow studies after hypospadias repair: a systematic review. Int J Urol. 2011 Nov;18(11):757-61. doi: 10.1111/j.1442-2042.2011.02839.x. Epub 2011 Aug 30. Review. — View Citation

Holmdahl G, Karström L, Abrahamsson K, Doroszkiewicz M, Sillén U. Hypospadias repair with tubularized incised plate. Is uroflowmetry necessary postoperatively? J Pediatr Urol. 2006 Aug;2(4):304-7. doi: 10.1016/j.jpurol.2005.11.018. Epub 2006 Mar 30. — View Citation

Jayanthi VR, McLorie GA, Khoury AE, Churchill BM. Functional characteristics of the reconstructed neourethra after island flap urethroplasty. J Urol. 1995 May;153(5):1657-9. — View Citation

Kaya C, Kucuk E, Ilktac A, Ozturk M, Karaman MI. Value of urinary flow patterns in the follow-up of children who underwent Snodgrass operation. Urol Int. 2007;78(3):245-8. — View Citation

Olsen LH, Grothe I, Rawashdeh YF, Jørgensen TM. Urinary flow patterns in infants with distal hypospadias. J Pediatr Urol. 2011 Aug;7(4):428-32. doi: 10.1016/j.jpurol.2010.05.013. Epub 2010 Jul 2. — View Citation

Page RE, Akin Y. Assessment of urine flow in hypospadias. Br J Plast Surg. 1978 Oct;31(4):313-6. — View Citation

Scarpa MG, Castagnetti M, Berrettini A, Rigamonti W, Musi L. Urinary function after Snodgrass repair of distal hypospadias: comparison with the Mathieu repair. Pediatr Surg Int. 2010 May;26(5):519-22. doi: 10.1007/s00383-010-2569-6. Epub 2010 Feb 19. — View Citation

Toguri AG, Uchida T, Bee DE. Pediatric uroflow rate nomograms. J Urol. 1982 Apr;127(4):727-31. — View Citation

Tuygun C, Bakirtas H, Gucuk A, Cakici H, Imamoglu A. Uroflow findings in older boys with tubularized incised-plate urethroplasty. Urol Int. 2009;82(1):71-6. doi: 10.1159/000176029. Epub 2009 Jan 20. — View Citation

Wolffenbuttel KP, Wondergem N, Hoefnagels JJ, Dieleman GC, Pel JJ, Passchier BT, de Jong BW, van Dijk W, Kok DJ. Abnormal urine flow in boys with distal hypospadias before and after correction. J Urol. 2006 Oct;176(4 Pt 2):1733-6; discussion 1736-7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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
Primary	Number of patients in each Type of the curve of the uroflowmetry.	Number of patients in each Type of the curve of the uroflowmetry.	Within 5 years postoperative
Primary	Finding correlation between the results of uroflowmetry and HOSE score.	Finding correlation between the results of uroflowmetry and HOSE score.	Within 5 years postoperative