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NCT Number: NCT07017842

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

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.

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Key information

Conditions

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

Age range

1 year–12 year

Sex eligibility

Male

Study type

Observational

Primary location

Sidra Medicine

Doha, Baladiyat ad Dawhah, 26999, Qatar

Location status: Recruiting

Location contact

Maraeh Angela Mancha

CONTACT

[email protected]

+974-40033333

Tariq O Abbas, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

Male patients aged 1 to 12 years

Diagnosed with hypospadias (distal, midpenile, proximal)

Undergoing primary surgical repair

Parent/legal guardian consent obtained

  • Exclusion Criteria:

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

Treatment and study plan

Primary outcomes

  1. Primary Outcome:

    Time frame: minimum 6 months post-surgery

    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.

Secondary outcomes

  1. Individual Complication Rates Following Hypospadias Repair

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

    The frequency of specific postoperative complications-including urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection, and need for surgical revision-will be assessed in patients undergoing primary hypospadias repair.

  2. Cosmetic and Functional Outcomes After Hypospadias Surgery

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

    Cosmetic appearance and functional urinary outcomes will be evaluated using validated scoring systems and satisfaction surveys completed by surgeons and parents at follow-up visits scheduled at 1, 3, and 6 months post-surgery. A minimum follow-up of 6 months is required for all patients, with an optional assessment at 12 months for long-term outcome validation.

  3. Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications

    Time frame: Based on data collected during a minimum 6 months after surgery

    Statistical analyses will evaluate associations between preoperative anatomical measurements and individual postoperative complications. Data collection and follow-up for these analyses require a minimum postoperative period of 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Maraeh Angela Mancha

CONTACT

[email protected]

+974-40033333

Sponsors and collaborators

Lead sponsor

Sidra Medicine

Other

Registry information

Acronym: PREDICT-H

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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