Clinical trial NCT04142632: Long Term Follow-up for Hypospadias
Official title: Long Term Follow-up for Hypospadias. Hypospadias KOK
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypospadias
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 300
Sex: MALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Event Free Survival
timeFrame: Day 0
Secondary outcomes:
measure: Penis size
timeFrame: Day 0
measure: Urinary symptoms
timeFrame: Day 0
measure: quality of the urinary flow: straight or not straight
timeFrame: Day 0
measure: occurrence of urinary infection
timeFrame: Day 0
measure: sexual activity
timeFrame: Day 0
measure: occurrence of ejaculation
timeFrame: Day 0
measure: occurrence of erection
timeFrame: Day 0
measure: Pre-voiding bladder volume
timeFrame: Day 0
measure: post-voiding bladder volume
timeFrame: Day 0
measure: Flow measurement
timeFrame: Day 0
measure: Testicular ultrasonography
timeFrame: day 0
measure: puberty clinical signs
timeFrame: Day 0
measure: endocrine disorder
timeFrame: Day 0
measure: patient satisfaction
timeFrame: day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
name: Valeska BIDAULT, MD
role: PRINCIPAL_INVESTIGATOR
References: