Long Term Follow-up for Hypospadias (KOK)

Long Term Follow-up for Hypospadias. Hypospadias KOK

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.

Study Overview

• Status: Recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: clinical and paraclinical examination

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Valeska Bidault, MD; Phone Number: +33 04 27 86 92 12; Email: valeska.bidault@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
    • Contact: Valeska Bidault, MD; Phone Number: +33 04 27 86 92 12; Email: valeska.bidault@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
long term evaluation of hypospadias surgery	Procedure: clinical and paraclinical examination; Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival	Time with no complication after the last surgery for hypospadias	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penis size		Day 0
Urinary symptoms	The investigator will do an interrogation of the patient about urinary symptoms, the response will be yes or no.	Day 0
quality of the urinary flow: straight or not straight		Day 0
occurrence of urinary infection		Day 0
sexual activity	The investigator will do an interrogation of the patient about sexual activity, the response will be yes or no.	Day 0
occurrence of ejaculation		Day 0
occurrence of erection		Day 0
Pre-voiding bladder volume		Day 0
post-voiding bladder volume		Day 0
Flow measurement	The investigator will use an urinary flowmeter; the investigator will collect data with a curve for each patient, with time in x-axis and ml/s in y-axis.	Day 0
Testicular ultrasonography	The investigator will ask a testicular ultrasonography which will be performed by a radiologist, the following data will be collected: testicular volume, aspect of the testicular parenchyma.	day 0
puberty clinical signs	The investigator will use the tanner's criteria during the physical examination. Stages of genital [G] and pubic hair [Ph] development in the male. G-1, Ph-1: pre-pubertal; G-2: the testis and scrotum enlarge, and the skin of the scrotum shows some reddening and change in the texture. Sparse growth of pigmented hair usually slightly curly, mainly at the base of the penis (Ph-2); G-3: Testis and scrotum enlarge further, the penis grows mainly in length but also in breadth. The hair is darker, coarser and curlier and spreads over the junction of the pubes (Ph-3); G-4: Scrotum, testis, and penis grow further with development of the glans, and further darkening of the scrotal skin. The hair spreads covering the pubes; G-5: adult stage with spreading of the hair to the medial surface of the thighs (Ph-5).	Day 0
endocrine disorder		Day 0
patient satisfaction	The investigator will do an interrogation of the patient about his personal satisfaction, the response will be yes or no.	day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Valeska BIDAULT, MD, Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Estimated): February 17, 2026
• Study Completion (Estimated): February 17, 2026

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: 69HCL19_0334; 2019-A02136-51 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No