Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications (HYPOSPADES)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Hypospadias

Treatments: Radiation: Wrist X ray; Procedure: Blood test; Drug: Placebo; Drug: promestriene; Procedure: Urethroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01370798

2010-023686-22 (EudraCT Number)

2010.608

Details and patient eligibility

About

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.

Enrollment: 244 patients

Sex: Male

Ages: 9 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe hypospadias with a division of the corpus spongiosum behind the midshaft of the penis and for which repair requires a urethral substitution by onlay urethroplasty.
• Subjects operated between 9 and 36 months old.
• Subjects operated in one of the departments of paediatric urology involved in the study.
• Surgery performed by a surgeon with at least 5 years of practical experience in the hypospadias surgery.
• Written informed consent obtained from parents or legal guardians prior to the participation to the study
• All hypospadias aetiology (hormonal, karyotype or genetic)

Exclusion criteria

• Refusal to participate
• Subjects with glandular hypospadias
• Subjects aged <9 months or > 36months old at time of surgery.
• Subjects who had prior surgery of penis (circumcision or hypospadias surgery)
• Subjects treated with androgens (Human Chorionic Gonadotrophin or delayed testosterone) within 6 months prior to surgery.
• Intolerance to promestriene or its excipients.
• Not affiliated to a healthy or social security cover.
• Known tumoral risk
• Pure or mixed gonadal dysgenesis (45, X0/46,XY)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 2 patient groups, including a placebo group

promestriene

Experimental group

Description:

Children with severe hypospadias treated with promestriene 1%

Treatment:

Procedure: Urethroplasty

Drug: promestriene

Procedure: Blood test

Radiation: Wrist X ray

Placebo

Placebo Comparator group

Description:

Control group, children with severe hypospadias treated with Placebo.

Treatment:

Procedure: Urethroplasty

Drug: Placebo

Procedure: Blood test

Radiation: Wrist X ray