Health Condition 1: Q548- Other hypospadias
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Intervention/ Testosterone group (TG): TG - receiving dermal testosterone gel.
Control Intervention1: Control group (CG): CG group will be receiving a placebo (n
Sponsors
Medical Research Unit MRU AIIMS Raebareli
Eligibility
Inclusion criteria
Inclusion criteria: children with mid/ proximal penile hypospadias
Exclusion criteria
Exclusion criteria: Children with underlying disorders of sexual differentiation. Children with any other variants of hypospadias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the penile dimensions (such as stretched dorsal/ventral penile length, Penile diameter and glans circumference) between the testosterone and control groups post-hypospadias repairTimepoint: Baseline, 1 month of starting the treatment, 3months of starting the treatment, 6months of starting the treatment and 12 months of starting the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess differences in post operative complications (e.g., Urethro-cutaneous fistula & Meatal Stenosis).Timepoint: Baseline, 1month, 3 months, 6months & 12 months;To evaluate systemic & local complications of dermal testosterone therapyTimepoint: Baseline, 1month, 3 months, 6 months, & 12 months. Or at every visit;To assess hormonal changes (Ts), LH/FSH) over timeTimepoint: Baseline, 1 month, 3 months, 6 months, & 12 months.;To monitor changes in bone mineral density via DEXA (dual-energy x-ray absorptiometry scan)Timepoint: At baseline & 12 months;To evaluate caregiver satisfaction using standardized scoring systems (Pediatric penile perception score, Likert).Timepoint: At 3 months & 12 months. | — |
Countries
India
Contacts
Public ContactDivya Prakash
All India Institute of Medical Sciences, Raebareli, U.P.
Outcome results
None listed