Long Term Follow-up for Hypospadias

Hypospadias Clinical Trial

— KOK  

Official title:

Long Term Follow-up for Hypospadias. Hypospadias KOK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142632
• Other study ID #: 69HCL19_0334
• Secondary ID: 2019-A02136-51
• Status: Recruiting
• Start date: February 17, 2020
• Est. completion date: February 17, 2026

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Valeska BIDAULT, MD
• Phone: 04 27 86 92 12
• Email: valeska.bidault[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 17, 2026
• Est. primary completion date: February 17, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypospadias

Intervention

Procedure:
• clinical and paraclinical examination
Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment

Locations

Country	Name	City	State
France	Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant	Bron

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	Event Free Survival	Time with no complication after the last surgery for hypospadias	Day 0
Secondary	Penis size		Day 0
Secondary	Urinary symptoms	The investigator will do an interrogation of the patient about urinary symptoms, the response will be yes or no.	Day 0
Secondary	quality of the urinary flow: straight or not straight		Day 0
Secondary	occurrence of urinary infection		Day 0
Secondary	sexual activity	The investigator will do an interrogation of the patient about sexual activity, the response will be yes or no.	Day 0
Secondary	occurrence of ejaculation		Day 0
Secondary	occurrence of erection		Day 0
Secondary	Pre-voiding bladder volume		Day 0
Secondary	post-voiding bladder volume		Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	endocrine disorder		Day 0
Secondary	patient satisfaction	The investigator will do an interrogation of the patient about his personal satisfaction, the response will be yes or no.	day 0