An observational study in Hypospadias, sponsored by Sidra Medicine. Recruiting at 1 site in Qatar. Open to male participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Sidra Medicine · Observational
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.
123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 138 across 20 observational studies indexed under Hypospadias.
Browse Hypospadias studies →Sidra Medicine is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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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.
* 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
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.
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.
Time frame: minimum 6 months post-surgery
Individual Complication Rates Following Hypospadias Repair
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Based on data collected during a minimum 6 months after surgery
Plan to share: Yes — De-identified individual participant data, including anatomical measurements, surgical details, and postoperative outcomes, will be made available to qualified researchers upon reasonable request following publication of the primary study results. Data sharing will comply with all applicable privacy regulations and institutional policies to ensure participant confidentiality. Requests will be reviewed by the study steering committee, and data will be shared via a secure platform after completion of a data use agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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