HypospadiasKOKNCT04142632
Long Term Follow-up for Hypospadias
An observational study of Hypospadias, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- clinical and paraclinical examination
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2020to 28 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient deceased
- Non- agreement from the patient or his parents
- Language difficulties
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
Bron, 69500
About this study
Official title: 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.
- Conditions
- Hypospadias
- Being tested
- clinical and paraclinical examination
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and paraclinical examinationProcedure or surgery
Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment
| Study group | Role | What they receive |
|---|---|---|
| long term evaluation of hypospadias surgery | Not described Receives: Procedure: clinical and paraclinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Time with no complication after the last surgery for hypospadias
Measured: Day 0
Secondary outcomes (14)
Penis size
Measured: Day 0
Urinary symptoms
The investigator will do an interrogation of the patient about urinary symptoms, the response will be yes or no.
Measured: Day 0
quality of the urinary flow: straight or not straight
Measured: Day 0
occurrence of urinary infection
Measured: Day 0
sexual activity
The investigator will do an interrogation of the patient about sexual activity, the response will be yes or no.
Measured: Day 0
occurrence of ejaculation
Measured: Day 0
occurrence of erection
Measured: Day 0
Pre-voiding bladder volume
Measured: Day 0
post-voiding bladder volume
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 0
endocrine disorder
Measured: Day 0
patient satisfaction
The investigator will do an interrogation of the patient about his personal satisfaction, the response will be yes or no.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start17 Feb 2020
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valeska BIDAULT, MD, Principal investigator, Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142632
- Sponsor's protocol ID
- 69HCL19_0334
- Other IDs
- 2019-A02136-51
- Acronym
- KOK
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2019
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up for Hypospadias. Hypospadias KOK
- ClinicalTrials.gov ID
- NCT04142632
- Acronym / sponsor ID
- KOK / 69HCL19_0334
- Conditions
- Hypospadias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| long term evaluation of hypospadias surgery | – | Procedure: clinical and paraclinical examination |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient deceased
- Non- agreement from the patient or his parents
- Language difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and paraclinical examinationPhysical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment | Procedure or surgery | long term evaluation of hypospadias surgery |
Primary outcome
Event Free Survival
Time frame: Day 0
Time with no complication after the last surgery for hypospadias
14 secondary outcomes
Penis size
Time frame: Day 0
Urinary symptoms
Time frame: Day 0
quality of the urinary flow: straight or not straight
Time frame: Day 0
occurrence of urinary infection
Time frame: Day 0
sexual activity
Time frame: Day 0
occurrence of ejaculation
Time frame: Day 0
occurrence of erection
Time frame: Day 0
Pre-voiding bladder volume
Time frame: Day 0
post-voiding bladder volume
Time frame: Day 0
Flow measurement
Time frame: Day 0
Testicular ultrasonography
Time frame: day 0
puberty clinical signs
Time frame: Day 0
endocrine disorder
Time frame: Day 0
patient satisfaction
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeska BIDAULT, MD principal investigator
Hospices Civils de Lyon Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadias, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.