Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions. A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects. The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
244
Promestriene cream 1%, 1g per day during 2 months, cutaneous application
Placebo of promestriene cream, 1g per day during 2 months, cutaneous application
Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability)
Wrist X ray to follow the degree of bone maturation
Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH
Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant
Bron, France
Hôpital Mère-Enfant
Nantes, France
Hôpital Robert Debré
Paris, France
Hôpital NECKER
Paris, France
Number of patient with postoperative urethral fistula and dehiscence
Time frame: 1 year
Re-intervention related to wound healing
Number of re-interventions for fistula or dehiscence not related to stenosis, in the first year post surgery.
Time frame: 1 year
post-surgical complications
Total number and type of post-surgical complications
Time frame: 1 year
Re-intervention not related to wound healing
Number of re-interventions not related to wound healing
Time frame: 1 year
Hormone measurement
Plasmatic concentrations of Oestradiol, Testosterone, LH, FSH at inclusion and at 2 months (at the end of study treatment)
Time frame: 2 months
Bone age evaluation
Hand and wrist radiography at inclusion and 1 year after surgery.
Time frame: 14 monthes
Clinical tolerance of the treatment
Number and type of adverse events
Time frame: 14 months
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