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Completed

NCT Number: NCT03593720

Glans Size in Hypospadias Compared to Normal

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Measurement in Office

Procedure

Penile length and glans size in 3 dimensions

Measurement in OR

Procedure

Penile length and glans size in 3 dimensions

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2018
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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