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

Hypospadias Clinical Trial

— HYPOSPADES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370798
• Other study ID #: 2010.608
• Secondary ID: 2010-023686-22
• Status: Completed
• Phase: Phase 3
• Start date: May 26, 2011
• Est. completion date: September 18, 2017

Study information

• Verified date: July 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 9 Months to 36 Months

Eligibility

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)

Related Conditions & MeSH terms

• Hypospadias
• Postoperative Complications

Intervention

Drug:
• promestriene
Promestriene cream 1%, 1g per day during 2 months, cutaneous application
• Placebo
Placebo of promestriene cream, 1g per day during 2 months, cutaneous application

Procedure:
• Urethroplasty
Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability)

Radiation:
• Wrist X ray
Wrist X ray to follow the degree of bone maturation

Procedure:
• Blood test
Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH

Locations

Country	Name	City	State
France	Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant	Bron Cedex
France	Hôpital Mère-Enfant	Nantes
France	Hôpital NECKER	Paris
France	Hôpital Robert Debré	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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