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

NCT ID: NCT05032222

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-05-01

Brief Summary

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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

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Conditions

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Hypospadias

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Uroflowmetry

Diagnostic test

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mohammad Alaa Ezzat

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Alaa Ezzat

Resident

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hisham M Hammoda, Professor

Role: STUDY_DIRECTOR

Assiut University

Amr H Abo fadan, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Mahmoud F Ali, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamad A Ezzat, Resident

Role: CONTACT

+201125035035

Facility Contacts

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Mohamad A Ezzat, Resident

Role: primary

+201028511082

References

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Olsen LH, Grothe I, Rawashdeh YF, Jorgensen 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.

Reference Type BACKGROUND
PMID: 20598640 (View on PubMed)

Page RE, Akin Y. Assessment of urine flow in hypospadias. Br J Plast Surg. 1978 Oct;31(4):313-6. doi: 10.1016/s0007-1226(78)90117-0. No abstract available.

Reference Type BACKGROUND
PMID: 152135 (View on PubMed)

Toguri AG, Uchida T, Bee DE. Pediatric uroflow rate nomograms. J Urol. 1982 Apr;127(4):727-31. doi: 10.1016/s0022-5347(17)54018-5. No abstract available.

Reference Type BACKGROUND
PMID: 7069841 (View on PubMed)

Gonzalez 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.

Reference Type BACKGROUND
PMID: 21883491 (View on PubMed)

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. doi: 10.1159/000099346.

Reference Type BACKGROUND
PMID: 17406135 (View on PubMed)

Holmdahl G, Karstrom L, Abrahamsson K, Doroszkiewicz M, Sillen 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.

Reference Type BACKGROUND
PMID: 18947626 (View on PubMed)

Garignon C, Chamond C, Lefebure 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.

Reference Type BACKGROUND
PMID: 15751419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7715002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20169443 (View on PubMed)

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. doi: 10.1016/S0022-5347(06)00614-8.

Reference Type BACKGROUND
PMID: 16945635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19172101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23093529 (View on PubMed)

Other Identifiers

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Hypospadias repair evaluation

Identifier Type: -

Identifier Source: org_study_id

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