A Randomised Controlled Trial evaluating the effect of Topical Testosterone Therapy following Hypospadias repair in Paediatric patients.

Hypospadias is among the most common anatomical congenital anomalies affecting the male external genitalia, where surgical correction is the only treatment modality. While surgical techniques have improved, many post-pubertal patients remain dissatisfied with penile size, appearance, and functional outcomes, particularly in cases of moderate/proximal hypospadias with chordee.

Although preoperative hormonal stimulation (PHS) is well established to improve local tissue characteristics and penile dimensions before surgery, the potential benefits of postoperative hormonal stimulation (PHS-post) have not been adequately explored. Given the documented dissatisfaction and psychosocial impact among adolescents and adults post-repair, topical testosterone application after surgical correction may offer additional benefits in penile growth, cosmesis, and quality of life.

This open-label, randomised controlled trial aims to evaluate the efficacy of dermal testosterone gel applied postoperatively in children who have undergone hypospadias repair. A total of 50 patients (minimum 25 in each group), aged between 1 and 18 years, who meet the inclusion criteria will be enrolled. Participants will be randomised into two arms: the intervention group (TG) receiving dermal testosterone gel and the control group (CG) receiving a placebo (neutral body lotion). Parents/caregivers will be instructed on proper application technique.

Outcomes will be measured over a 12-month period and will include penile dimensions (dorsal/ventral stretched penile length, glans circumference, and penile diameter), incidence of postoperative complications (fistula, meatal stenosis), hormonal parameters (serum testosterone, LH, FSH), bone mineral density changes via DEXA, and caregiver-reported satisfaction using validated scales (PPPS, Likert).

This study will provide critical insights into the therapeutic potential of postoperative hormonal therapy in improving both physical and psychosocial outcomes following hypospadias surgery. The results could establish a new standard of care, particularly in moderate to severe hypospadias or in cases with post-operative complications. It may also inform long-term follow-up practices and quality of life assessments in these patients.