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Glans Size in Hypospadias Compared to Normal

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ClinicalTrials.gov Identifier: NCT03593720
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2018
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Barry Kogan, MD, Albany Medical College

Study Description
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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.

Condition or disease Intervention/treatment
Hypospadias Surgery Non Hypospadias Procedure: Measurement in Office Procedure: Measurement in OR

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 Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glans Size in Hypospadias Compared to Normal
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : December 29, 2022
Estimated Study Completion Date : December 29, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593720


Locations
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United States, New York
Albany Medical College
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Barry Kogan, MD Albany Medical College
More Information
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Publications:

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Responsible Party: Barry Kogan, MD, Professor of Surgery and Pediatrics, Albany Medical College
ClinicalTrials.gov Identifier: NCT03593720    
Other Study ID Numbers: AMC5152
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barry Kogan, MD, Albany Medical College:
hypaspadias
Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Urogenital Abnormalities
Congenital Abnormalities