Differences in Messenger RNA Expression of Fibulin-1, Elastin, Matrix Metalloproteinase-1, Basic Fibroblast Growth Factor, and α-Smooth Muscle Actin Between the Ventral and Dorsal Tunica Dartos in Patients With Hypospadias and Chordee: Protocol for a Prospective Cohort Study.

Background: Hypospadias is a common congenital anomaly characterized by the displacement of the urethral opening to the ventral side of the penis. Surgical correction is often necessary for functional and psychological reasons. The etiology involves genetic and environmental factors, and chordee, a downward curvature of the penis, is a common complication. Proteins such as fibulin-1, elastin, matrix metalloproteinase-1, basic fibroblast growth factor, and α-smooth muscle actin play roles in hypospadias development.

Objective: The study's aim is to investigate the differences in messenger RNA (mRNA) expression of fibulin-1, elastin, matrix metalloproteinase-1, basic fibroblast growth factor, and α-smooth muscle actin between the ventral and dorsal tunica dartos in patients with hypospadias and chordee.

Methods: This prospective cohort study aims to investigate differences in mRNA expression of the abovementioned proteins between the ventral and dorsal tunica dartos in patients with hypospadias and chordee. Ethics approval has been obtained, and consent from parents will be obtained before data collection. Eligible participants are aged 6-18 months, diagnosed with hypospadias and chordee, and planned for urethroplasty. Tissue samples will be collected from both aspects of the tunica dartos and analyzed using real-time quantitative reverse transcription-polymerase chain reaction. Data analysis will involve statistical tests and normalization of housekeeping genes.

Results: This study is at the protocol development stage. A pilot study regarding its feasibility has been ongoing as of August 2023. The study results are expected to be available by the end of 2024.

Conclusions: The study of mRNA expressions of various proteins in the tunica dartos of patients with hypospadias and chordee is expected to improve the understanding and expand the knowledge of the pathophysiology of hypospadias and chordee.

International registered report identifier (irrid): DERR1-10.2196/52282.