Glans Size in Hypospadias Compared to Normal

March 30, 2023 updated by: Barry Kogan, MD, Albany Medical College
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

After obtaining informed consent , the investigator will measure stretched penile length and glans size in 3 dimensions (length, width, height) in the office on patients with hypospadias, as well as at the time of operation, after the induction of anesthesia. Patients undergoing hypospadias surgery will be considered study subjects. If the patient was given pre-operative testosterone as part of the current standard of care, this will be noted and the measurements taken at each pre-operative office visit will be recorded. The investigator will also record corrected age, weight in kilograms and ethnicity as identified by the family.

Control patients will be those male patients undergoing non-hypospadias urological surgery (hernia repair, orchiopexy, circumcision, re-circumcision) with a normal penis, the investigator will perform a single intra-operative measurement of the same glans and penile variables after induction of anesthesia and prior to the start of their genital surgery. Again, age, weight and ethnicity will be recorded.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypospadias
Patients with hypospadias
Procedure: Measurement in Office
Penile length and glans size in 3 dimensions
Procedure: Measurement in OR
Penile length and glans size in 3 dimensions
Control
Patients without hypospadias
Procedure: Measurement in OR
Penile length and glans size in 3 dimensions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in glans size between hypospadias patients and those without hypospadias
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in penile length between hypospadias patients and those without hypospadias
Time Frame: 6 months
The investigator will prospectively collect data on penis length by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery
6 months
Track penile and glans growth curves in both cohorts
Time Frame: 24 months
The investigator will prospectively track penile and glans growth over time to develop longitudinal growth curves in both cohorts
24 months
Determine the effect of testosterone on penile and glans growth in hypospadias
Time Frame: 24 months
The investigator will measure the glans size and penile length of patients who receive testosterone for small glans size before and after administration in order to determine the effect of testosterone administration.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Investigators

  • Principal Investigator: Barry Kogan, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2018

Primary Completion (Anticipated)

December 29, 2023

Study Completion (Anticipated)

December 29, 2023

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC5152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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