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

Phase 3

Completed

• Conditions: Hypospadias
• Interventions: Drug: Placebo; Drug: promestriene; Procedure: Urethroplasty; Radiation: Wrist X ray; Procedure: Blood test

• Registration Number: NCT01370798
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-26
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2017-09-18
• Study Completion: 2017-09-18
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 244

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
promestriene	Wrist X ray	Children with severe hypospadias treated with promestriene 1%
Placebo	Placebo	Control group, children with severe hypospadias treated with Placebo.
Placebo	Urethroplasty	Control group, children with severe hypospadias treated with Placebo.
Placebo	Blood test	Control group, children with severe hypospadias treated with Placebo.
promestriene	promestriene	Children with severe hypospadias treated with promestriene 1%
promestriene	Urethroplasty	Children with severe hypospadias treated with promestriene 1%
promestriene	Blood test	Children with severe hypospadias treated with promestriene 1%
Placebo	Wrist X ray	Control group, children with severe hypospadias treated with Placebo.

Primary Outcome Measures

Name	Time	Method
Number of patient with postoperative urethral fistula and dehiscence	1 year

Secondary Outcome Measures

Name	Time	Method
Bone age evaluation	14 monthes	Hand and wrist radiography at inclusion and 1 year after surgery.
Clinical tolerance of the treatment	14 months	Number and type of adverse events
Re-intervention related to wound healing	1 year	Number of re-interventions for fistula or dehiscence not related to stenosis, in the first year post surgery.
post-surgical complications	1 year	Total number and type of post-surgical complications
Re-intervention not related to wound healing	1 year	Number of re-interventions not related to wound healing
Hormone measurement	2 months	Plasmatic concentrations of Oestradiol, Testosterone, LH, FSH at inclusion and at 2 months (at the end of study treatment)

Trial Locations

Locations (4)

Hôpital Mère-Enfant; 🇫🇷 Nantes, France

Hôpital NECKER; 🇫🇷 Paris, France

Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant; 🇫🇷 Bron Cedex, France

Hôpital Robert Debré; 🇫🇷 Paris, France