NCT03593720

Brief Summary

The investigator will collect data on penile and glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

6.4 years

First QC Date

July 10, 2018

Last Update Submit

October 30, 2025

Conditions

HypospadiasSurgery Non Hypospadias

Keywords

hypaspadias

Outcome Measures

Primary Outcomes (1)

  • Difference in glans size between hypospadias patients and those without hypospadias

    The investigator will prospectively collect data on glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery

    6 months

Secondary Outcomes (3)

  • Difference in penile length between hypospadias patients and those without hypospadias

    6 months

  • Track penile and glans growth curves in both cohorts

    24 months

  • Determine the effect of testosterone on penile and glans growth in hypospadias

    24 months

Study Arms (2)

Hypospadias

Patients with hypospadias

Procedure: Measurement in OfficeProcedure: Measurement in OR

Control

Patients without hypospadias

Procedure: Measurement in OR

Interventions

Measurement in OfficePROCEDURE

Penile length and glans size in 3 dimensions

Hypospadias
Measurement in ORPROCEDURE

Penile length and glans size in 3 dimensions

ControlHypospadias

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The source of subjects will be patients examined in the Pediatric Urology clinic and operating room. In contemporary practice, most hypospadias surgery is conducted at less than two years of age. Total of patients enrolled will be 90, with 45 in each the control and study group. The study population are patients undergoing surgery for hypospadias and the control population are patients undergoing any urologic surgery other than hypospadias.

You may qualify if:

  • Patients undergoing surgery for hypospadias
  • Patients undergoing any urologic surgery other than hypospadias

You may not qualify if:

  • other penile abnormalities (Hidden penis, penoscrotal wedding/transposition, chordee without hypospadias, penile torsion, etc.)
  • Undergoing other penile procedures (penoplasty, chordee repair, penile detorsion, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

Related Publications (11)

  • Babu R. Glans meatus proportion in hypospadias versus normal: does marking reference points impact outcome? J Pediatr Urol. 2014 Jun;10(3):459-62. doi: 10.1016/j.jpurol.2013.11.008. Epub 2013 Nov 28.

    PMID: 24332704BACKGROUND

  • Bush NC, DaJusta D, Snodgrass WT. Glans penis width in patients with hypospadias compared to healthy controls. J Pediatr Urol. 2013 Dec;9(6 Pt B):1188-91. doi: 10.1016/j.jpurol.2013.05.004. Epub 2013 Jun 12.

    PMID: 23768835BACKGROUND

  • Bush NC, Villanueva C, Snodgrass W. Glans size is an independent risk factor for urethroplasty complications after hypospadias repair. J Pediatr Urol. 2015 Dec;11(6):355.e1-5. doi: 10.1016/j.jpurol.2015.05.029. Epub 2015 Aug 13.

    PMID: 26320396BACKGROUND

  • Malik RD, Liu DB. Survey of pediatric urologists on the preoperative use of testosterone in the surgical correction of hypospadias. J Pediatr Urol. 2014 Oct;10(5):840-3. doi: 10.1016/j.jpurol.2014.02.008. Epub 2014 Mar 18.

    PMID: 24726783BACKGROUND

  • Babu R, Chakravarthi S. The role of preoperative intra muscular testosterone in improving functional and cosmetic outcomes following hypospadias repair: A prospective randomized study. J Pediatr Urol. 2018 Feb;14(1):29.e1-29.e6. doi: 10.1016/j.jpurol.2017.07.009. Epub 2017 Aug 12.

    PMID: 28844754BACKGROUND

  • Chua ME, Gnech M, Ming JM, Silangcruz JM, Sanger S, Lopes RI, Lorenzo AJ, Braga LH. Preoperative hormonal stimulation effect on hypospadias repair complications: Meta-analysis of observational versus randomized controlled studies. J Pediatr Urol. 2017 Oct;13(5):470-480. doi: 10.1016/j.jpurol.2017.06.019. Epub 2017 Jul 29.

    PMID: 28939350BACKGROUND

  • Rynja SP, de Jong TPVM, Bosch JLHR, de Kort LMO. Testosterone prior to hypospadias repair: Postoperative complication rates and long-term cosmetic results, penile length and body height. J Pediatr Urol. 2018 Feb;14(1):31.e1-31.e8. doi: 10.1016/j.jpurol.2017.09.020. Epub 2017 Oct 27.

    PMID: 29174377BACKGROUND

  • Van Praet C, Spinoit AF. Testosterone prior to hypospadias repair: No clear-cut benefit or reassurance regarding long-term safety. J Pediatr Urol. 2018 Feb;14(1):85-86. doi: 10.1016/j.jpurol.2017.11.006. Epub 2017 Nov 27. No abstract available.

    PMID: 29248308BACKGROUND

  • Asgari SA, Safarinejad MR, Poorreza F, Asl AS, Ghanaie MM, Shahab E. The effect of parenteral testosterone administration prior to hypospadias surgery: A prospective, randomized and controlled study. J Pediatr Urol. 2015 Jun;11(3):143.e1-6. doi: 10.1016/j.jpurol.2014.12.014. Epub 2015 Mar 12.

    PMID: 25837705BACKGROUND

  • Paiva KC, Bastos AN, Miana LP, Barros Ede S, Ramos PS, Miranda LM, Faria NM, Avarese de Figueiredo A, de Bessa J Jr, Netto JM. Biometry of the hypospadic penis after hormone therapy (testosterone and estrogen): A randomized, double-blind controlled trial. J Pediatr Urol. 2016 Aug;12(4):200.e1-6. doi: 10.1016/j.jpurol.2016.04.013. Epub 2016 May 26.

    PMID: 27321554BACKGROUND

  • Puri A, Sikdar S, Prakash R. Pediatric Penile and Glans Anthropometry Nomograms: An Aid in Hypospadias Management. J Indian Assoc Pediatr Surg. 2017 Jan-Mar;22(1):9-12. doi: 10.4103/0971-9261.194610.

    PMID: 28082769BACKGROUND

MeSH Terms

Conditions

Hypospadias

Interventions

Weights and MeasuresWorking Conditions

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative TechniquesWorkplaceEmploymentSocioeconomic FactorsPopulation CharacteristicsPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Officials

  • Barry Kogan, MD

    Albany Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery and Pediatrics

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 20, 2018

Study Start

July 25, 2018

Primary Completion

December 29, 2024

Study Completion

December 29, 2024

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)