Glans Size in Hypospadias Compared to Normal

• Conditions: Surgery Non Hypospadias; Hypospadias
• Interventions: Procedure: Measurement in Office; Procedure: Measurement in OR

• Registration Number: NCT03593720
• Lead Sponsor: Albany Medical College

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.

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 Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-20
• Study Start: 2018-07-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-12-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypospadias	Measurement in Office	Patients with hypospadias
Hypospadias	Measurement in OR	Patients with hypospadias
Control	Measurement in OR	Patients without hypospadias

Primary Outcome Measures

Name	Time	Method
Difference in glans size between hypospadias patients and those without hypospadias	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 Outcome Measures

Name	Time	Method
Difference in penile length between hypospadias patients and those without hypospadias	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
Determine the effect of testosterone on penile and glans growth in hypospadias	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.
Track penile and glans growth curves in both cohorts	24 months	The investigator will prospectively track penile and glans growth over time to develop longitudinal growth curves in both cohorts

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States