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Completed

NCT Number: NCT04142632

Long Term Follow-up for Hypospadias

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.

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Key information

Age range

14 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical and paraclinical examination

Procedure

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

Primary outcomes

  1. Event Free Survival

    Time frame: Day 0

    Time with no complication after the last surgery for hypospadias

Secondary outcomes

  1. Penis size

    Time frame: Day 0

  2. Urinary symptoms

    Time frame: Day 0

    The investigator will do an interrogation of the patient about urinary symptoms, the response will be yes or no.

  3. quality of the urinary flow: straight or not straight

    Time frame: Day 0

  4. occurrence of urinary infection

    Time frame: Day 0

  5. sexual activity

    Time frame: Day 0

    The investigator will do an interrogation of the patient about sexual activity, the response will be yes or no.

  6. occurrence of ejaculation

    Time frame: Day 0

  7. occurrence of erection

    Time frame: Day 0

  8. Pre-voiding bladder volume

    Time frame: Day 0

  9. post-voiding bladder volume

    Time frame: Day 0

  10. Flow measurement

    Time frame: Day 0

    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.

  11. Testicular ultrasonography

    Time frame: day 0

    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.

  12. puberty clinical signs

    Time frame: Day 0

    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).

  13. endocrine disorder

    Time frame: Day 0

  14. patient satisfaction

    Time frame: day 0

    The investigator will do an interrogation of the patient about his personal satisfaction, the response will be yes or no.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Long Term Follow-up for Hypospadias. Hypospadias KOK

Acronym: KOK

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2019
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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