Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06832280

Conditions

Hypospadias

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Educational Website Developed by Study Team

Basic Educational Website

Study Details

Brief summary:

The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.

Conditions

Hypospadias

Study ID

NCT06832280

Start date

May 7, 2025

Status verified date

Jun, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Jul 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria

A parent must meet all of the following criteria to be included:

  • Age ≥ 18 years old
  • Fluent and literate in English or Spanish
  • Parent or legal guardian
  • Ability to consent
  • One eligible parent per child
  • Plan to attend urology consultation
  • Has access to a smart phone, tablet, or computer with reliable internet access
  • Has the ability and agrees to receive unencrypted communications by text or email

A child must meet all of the following criteria to be included:

  • 0-5 years old at the time of urology consultation
  • Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias

Exclusion Criteria

If a parent meets any of the following criteria they will be excluded:

  • Previous participant in hypospadias study
  • Parent has another child with hypospadias or father of the child has a known history of hypospadias
  • Parent is unaware of any penile abnormality with child
  • A final hypospadias treatment decision has been made in discussion with a pediatric urologist
  • Investigator discretion

If a child meets any of the following criteria they will be excluded:

  • Prior hypospadias surgery
  • Upcoming hypospadias urology consult is less than five days away from when the patient was identified

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Enhanced Hypospadias Education

The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team.

sham comparator: Basic Hypospadias Education

Parents randomized into the control arm will receive access to a basic educational website about hypospadias.

Interventions

Educational Website Developed by Study Team

This website was developed by the study team in previous research studies.

Basic Educational Website

This website is a basic education website about hypospadias.

Primary outcome measure

  • Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)* [ Time Frame: Post-clinic visit, 1-30 days after the final clinic visit (T3) ]
  • Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)** [ Time Frame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a. ]

Central Contacts and Locations

Central contacts

Ariel Lunsford, BA

919-966-0690improvinghypocare@unc.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Stacy Keller, MSN, CPNP

317-278-6127stasulli@iu.edu

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Ariel Lunsford, BA

919-966-0690improvinghypocare@unc.edu

Principal Investigator:

Samantha Schilling, MD, MSHP

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Hypospadias
  • Pediatric Urologists

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-30.