PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery

NCT07017842 | Recruiting DMC

• 1 other identifier: SDR600058
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

• Primary Outcome:

  Composite rate of postoperative complications within 6 months, including: urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection requiring treatment, and need for surgical revision.

  minimum 6 months post-surgery

Secondary Outcomes (3)

• Individual Complication Rates Following Hypospadias Repair

  At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit

• Cosmetic and Functional Outcomes After Hypospadias Surgery

  At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit

• Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications

  Based on data collected during a minimum 6 months after surgery

Study Arms (1)

Hypospadias (Age 1-12 years old)

This study includes a single prospective observational cohort of male pediatric patients aged 1 to 12 years undergoing primary surgical repair for hypospadias at participating tertiary pediatric urology centers. No experimental interventions are assigned by the study; instead, patients receive standard-of-care surgical techniques as determined by their treating surgeons. Detailed preoperative anatomical assessments and surgical procedure documentation are collected to evaluate the impact of anatomical variables and surgical approaches on postoperative complication rates. Subgroup analyses will be performed based on hypospadias severity (distal, midpenile, proximal) and the surgical technique utilized.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Male patients aged 1 to 12 years with diagnosed distal, midpenile, or proximal hypospadias scheduled for primary surgical repair will be enrolled. Exclusion criteria include prior hypospadias or penile surgery, major genital anomalies (e.g., ambiguous genitalia, severe DSD), inability or refusal to consent, or incomplete follow-up. Patients will be recruited from multiple tertiary pediatric urology centers. Informed consent will be obtained from parents or legal guardians. All participants will be followed for a minimum of 6 months postoperatively to assess surgical outcomes and complications.

You may qualify if:

• Male patients aged 1 to 12 years
• Diagnosed with hypospadias (distal, midpenile, proximal)
• Undergoing primary surgical repair
• Parent/legal guardian consent obtained

You may not qualify if:

• Prior hypospadias or penile surgery (revision cases)
• Major associated genital anomalies (e.g., ambiguous genitalia, severe DSD)
• Refusal of consent or inability to complete follow-up

Sponsors & Collaborators

• Sidra Medicine: lead

Study Sites (1)

Sidra Medicine

Doha, Baladīyat ad Dawḩah, 26999, Qatar

RECRUITING

Related Publications (5)

• Merriman LS, Arlen AM, Broecker BH, Smith EA, Kirsch AJ, Elmore JM. The GMS hypospadias score: assessment of inter-observer reliability and correlation with post-operative complications. J Pediatr Urol. 2013 Dec;9(6 Pt A):707-12. doi: 10.1016/j.jpurol.2013.04.006. Epub 2013 May 15.

  PMID: 23683961 BACKGROUND

• Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25.

  PMID: 38071112 BACKGROUND

• Baray SB, Abdelmoniem M, Mahmud S, Kabir S, Faisal MAA, Chowdhury MEH, Abbas TO. Automated measurement of penile curvature using deep learning-based novel quantification method. Front Pediatr. 2023 Apr 17;11:1149318. doi: 10.3389/fped.2023.1149318. eCollection 2023.

  PMID: 37138577 BACKGROUND

• Abbas TO, Vallasciani S, Elawad A, Elifranji M, Leslie B, Elkadhi A, Pippi Salle JL. Plate Objective Scoring Tool (POST); An objective methodology for the assessment of urethral plate in distal hypospadias. J Pediatr Urol. 2020 Oct;16(5):675-682. doi: 10.1016/j.jpurol.2020.07.043. Epub 2020 Aug 5.

  PMID: 32830060 BACKGROUND

• Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.

  PMID: 35644790 BACKGROUND

Related Links

• Hypospadias Registry

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maraeh Angela Mancha

CONTACT

+974-40033333; MMancha@sidra.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatric Urologist

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

QA (1)