HypospadiasPREDICT-HNCT07017842
PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery
An observational study of Hypospadias, run by Sidra Medicine at 1 site in Qatar.
Trial summary
Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men only
- Conditions the study is for
- Hypospadias
- How many people
- 1,300 participants
- Where
- 1 siteQatar
- Study dates
- 4 Jun 2025to 28 Feb 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 12 years
- Men only
- No healthy volunteers
- Child
Study population: Male patients aged 1 to 12 years with diagnosed distal, midpenile, or proximal hypospadias scheduled for primary surgical repair will be enrolled. Exclusion criteria include prior hypospadias or penile surgery, major genital anomalies (e.g., ambiguous genitalia, severe DSD), inability or refusal to consent, or incomplete follow-up. Patients will be recruited from multiple tertiary pediatric urology centers. Informed consent will be obtained from parents or legal guardians. All participants will be followed for a minimum of 6 months postoperatively to assess surgical outcomes and complications.
Who may be able to join
- Male patients aged 1 to 12 years
- Diagnosed with hypospadias (distal, midpenile, proximal)
- Undergoing primary surgical repair
- Parent/legal guardian consent obtained
Who cannot join
- Prior hypospadias or penile surgery (revision cases)
- Major associated genital anomalies (e.g., ambiguous genitalia, severe DSD)
- Refusal of consent or inability to complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Sidra Medicine
Doha, Baladiyat ad Dawhah, 26999
Maraeh Angela Mancha, +974-40033333, MMancha@sidra.org
Tariq O Abbas, MD, PhD
About this study
Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.
- Conditions
- Hypospadias
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypospadias (Age 1-12 years old) | This study includes a single prospective observational cohort of male pediatric patients aged 1 to 12 years undergoing primary surgical repair for hypospadias at participating tertiary pediatric urology centers. No experimental interventions are assigned by the study; instead, patients receive standard-of-care surgical techniques as determined by their treating surgeons. Detailed preoperative anatomical assessments and surgical procedure documentation are collected to evaluate the impact of anatomical variables and surgical approaches on postoperative complication rates. Subgroup analyses will be performed based on hypospadias severity (distal, midpenile, proximal) and the surgical technique utilized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome:
Composite rate of postoperative complications within 6 months, including: urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection requiring treatment, and need for surgical revision.
Measured: minimum 6 months post-surgery
Secondary outcomes (3)
Individual Complication Rates Following Hypospadias Repair
The frequency of specific postoperative complications-including urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection, and need for surgical revision-will be assessed in patients undergoing primary hypospadias repair.
Measured: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit
Cosmetic and Functional Outcomes After Hypospadias Surgery
Cosmetic appearance and functional urinary outcomes will be evaluated using validated scoring systems and satisfaction surveys completed by surgeons and parents at follow-up visits scheduled at 1, 3, and 6 months post-surgery. A minimum follow-up of 6 months is required for all patients, with an optional assessment at 12 months for long-term outcome validation.
Measured: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit
Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications
Statistical analyses will evaluate associations between preoperative anatomical measurements and individual postoperative complications. Data collection and follow-up for these analyses require a minimum postoperative period of 6 months.
Measured: Based on data collected during a minimum 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start4 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- 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
- 1,300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sidra Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tariq Abbas, Sidra Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017842
- Sponsor's protocol ID
- SDR600058
- Acronym
- PREDICT-H
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including anatomical measurements, surgical details, and postoperative outcomes, will be made available to qualified researchers upon reasonable request following publication of the primary study results. Data sharing will comply with all applicable privacy regulations and institutional policies to ensure participant confidentiality. Requests will be reviewed by the study steering committee, and data will be shared via a secure platform after completion of a data use agreement.
Publications
Merriman LS, Arlen AM, Broecker BH, Smith EA, Kirsch AJ, Elmore JM. The GMS hypospadias score: assessment of inter-observer reliability and correlation with post-operative complications. J Pediatr Urol. 2013 Dec;9(6 Pt A):707-12. doi: 10.1016/j.jpurol.2013.04.006. Epub 2013 May 15.
PubMed 23683961Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25.
PubMed 38071112Baray SB, Abdelmoniem M, Mahmud S, Kabir S, Faisal MAA, Chowdhury MEH, Abbas TO. Automated measurement of penile curvature using deep learning-based novel quantification method. Front Pediatr. 2023 Apr 17;11:1149318. doi: 10.3389/fped.2023.1149318. eCollection 2023.
PubMed 37138577Abbas TO, Vallasciani S, Elawad A, Elifranji M, Leslie B, Elkadhi A, Pippi Salle JL. Plate Objective Scoring Tool (POST); An objective methodology for the assessment of urethral plate in distal hypospadias. J Pediatr Urol. 2020 Oct;16(5):675-682. doi: 10.1016/j.jpurol.2020.07.043. Epub 2020 Aug 5.
PubMed 32830060Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
PubMed 35644790
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery
- ClinicalTrials.gov ID
- NCT07017842
- Acronym / sponsor ID
- PREDICT-H / SDR600058
- Conditions
- Hypospadias
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Sidra MedicineUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 12 Jun 2025 (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 common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypospadias (Age 1-12 years old) | – | –This study includes a single prospective observational cohort of male pediatric patients aged 1 to 12 years undergoing primary surgical repair for hypospadias at participating tertiary pediatric urology centers. No experimental interventions are assigned by the study; instead, patients receive standard-of-care surgical techniques as determined by their treating surgeons. Detailed preoperative anatomical assessments and surgical procedure documentation are collected to evaluate the impact of anatomical variables and surgical approaches on postoperative complication rates. Subgroup analyses will be performed based on hypospadias severity (distal, midpenile, proximal) and the surgical technique utilized. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male patients aged 1 to 12 years with diagnosed distal, midpenile, or proximal hypospadias scheduled for primary surgical repair will be enrolled. Exclusion criteria include prior hypospadias or penile surgery, major genital anomalies (e.g., ambiguous genitalia, severe DSD), inability or refusal to consent, or incomplete follow-up. Patients will be recruited from multiple tertiary pediatric urology centers. Informed consent will be obtained from parents or legal guardians. All participants will be followed for a minimum of 6 months postoperatively to assess surgical outcomes and complications.
Key inclusion criteria (4 listed)
- Male patients aged 1 to 12 years
- Diagnosed with hypospadias (distal, midpenile, proximal)
- Undergoing primary surgical repair
- Parent/legal guardian consent obtained
Key exclusion criteria (3 listed)
- Prior hypospadias or penile surgery (revision cases)
- Major associated genital anomalies (e.g., ambiguous genitalia, severe DSD)
- Refusal of consent or inability to complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome:
Time frame: minimum 6 months post-surgery
Composite rate of postoperative complications within 6 months, including: urethrocutaneous fistula, meatal stenosis, urethral stricture, recurrent chordee, wound infection requiring treatment, and need for surgical revision.
3 secondary outcomes
Individual Complication Rates Following Hypospadias Repair
Time frame: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months and last clinic visit
Cosmetic and Functional Outcomes After Hypospadias Surgery
Time frame: At 1 month, 3 months, and a minimum of 6 months post-surgery; optional assessment at 12 months or last clinic visit
Correlation Between Preoperative Anatomical Variables and Specific Postoperative Complications
Time frame: Based on data collected during a minimum 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 23683961Merriman LS, Arlen AM, Broecker BH, Smith EA, Kirsch AJ, Elmore JM. The GMS hypospadias score: assessment of inter-observer reliability and correlation with post-operative complications. J Pediatr Urol. 2013 Dec;9(6 Pt A):707-12. doi: 10.1016/j.jpurol.2013.04.006. Epub 2013 May 15.
- Background: PubMed 38071112Abbas TO, Khalil IA, Hatem M, Boyko A, Zorkin S. Plate Objective Scoring Tool (POST) in distal hypospadias: Correlation with post-repair complications. J Pediatr Urol. 2024 Apr;20(2):238.e1-238.e6. doi: 10.1016/j.jpurol.2023.11.022. Epub 2023 Nov 25.
- Background: PubMed 37138577Baray SB, Abdelmoniem M, Mahmud S, Kabir S, Faisal MAA, Chowdhury MEH, Abbas TO. Automated measurement of penile curvature using deep learning-based novel quantification method. Front Pediatr. 2023 Apr 17;11:1149318. doi: 10.3389/fped.2023.1149318. eCollection 2023.
- Background: PubMed 32830060Abbas TO, Vallasciani S, Elawad A, Elifranji M, Leslie B, Elkadhi A, Pippi Salle JL. Plate Objective Scoring Tool (POST); An objective methodology for the assessment of urethral plate in distal hypospadias. J Pediatr Urol. 2020 Oct;16(5):675-682. doi: 10.1016/j.jpurol.2020.07.043. Epub 2020 Aug 5.
- Background: PubMed 35644790Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
- Hypospadias RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including anatomical measurements, surgical details, and postoperative outcomes, will be made available to qualified researchers upon reasonable request following publication of the primary study results. Data sharing will comply with all applicable privacy regulations and institutional policies to ensure participant confidentiality. Requests will be reviewed by the study steering committee, and data will be shared via a secure platform after completion of a data use agreement.
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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.
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 Sidra Medicine at 1 site in Qatar.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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 Qatar. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maraeh Angela Mancha (+974-40033333, MMancha@sidra.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: (time frame: minimum 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017842, which also lists 5 linked publications.
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 12 Jun 2025.