Long Term Follow-up for Hypospadias

NCT04142632 | Completed

• 2 other identifiers: 69HCL19_03342019-A02136-51
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations. In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term. This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Time with no complication after the last surgery for hypospadias

  Day 0

Secondary Outcomes (14)

• Penis size

  Day 0

• Urinary symptoms

  Day 0

• quality of the urinary flow: straight or not straight

  Day 0

• occurrence of urinary infection

  Day 0

• sexual activity

  Day 0

Study Arms (1)

long term evaluation of hypospadias surgery

Procedure: clinical and paraclinical examination

Interventions

clinical and paraclinical examination PROCEDURE

Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment

long term evaluation of hypospadias surgery

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with previous hypospadias surgery, the intervention has to be realized before December the 31th 2005.The surgery was performed by one operator (Pr MOURIQUAND), with the following surgical technics: Koff, Onlay and Koyanagi. The patients are informed by an official surgery department letter, to assure they agree to participate. If the patient is still an infant, the parental agreement will be necessary.

You may qualify if:

• Male patients
• with previous hypospadias surgery,
• Birthday before December the 31th 2009.
• The surgery was performed by one operator, with the following surgical technics: Koff, Onlay and Koyanagi.
• The patients are informed by an official surgery department letter, to assure they agree to participate.
• if the patient is still an infant, the parental agreement will be necessary.

You may not qualify if:

• Patient deceased
• Non- agreement from the patient or his parents
• Language difficulties

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endocrinian sample: testosterone, FSH, LH, AMH

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Valeska BIDAULT, MD

  Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 29, 2019
• Study Start: February 17, 2020
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (1)