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Trial record 7 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Penile Diseases"

Glans Size in Hypospadias Compared to Normal

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ClinicalTrials.gov Identifier: NCT03593720
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Barry Kogan, MD, Albany Medical College

Brief Summary:
We 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 Hypospadius Procedure: Measurement in Office Procedure: Measurement in OR

Detailed Description:

After obtaining informed consent , we 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. We 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, we 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
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glans Size in Hypospadias Compared to Normal
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Group/Cohort Intervention/treatment
Hypospadius
Patients with hypospadias
Procedure: Measurement in Office
Penile length and glans size in 3 dimentions

Procedure: Measurement in OR
Penile length and glans size in 3 dimentions

Control
Patients without hypospadias
Procedure: Measurement in OR
Penile length and glans size in 3 dimentions




Primary Outcome Measures :
  1. Difference in glans size between hypospadias patients and those without hypospadias [ Time Frame: 6 months ]
    We 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 ]
    We 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 ]
    We 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 ]
    We 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.



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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.)

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


Contacts
Contact: Brenda Romeo, CCRC 518-262-8579 amcurologyresearch@amc.edu

Locations
United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
Contact: Brenda Romeo, CCRC         
Principal Investigator: Barry Kogan, MD         
Sub-Investigator: Adam Howe, MD         
Sub-Investigator: Ilija Aleksic, MD         
Sponsors and Collaborators
Albany Medical College
Investigators
Principal Investigator: Barry Kogan, MD Albany Medical College

Publications:

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

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:
hypaspadius

Additional relevant MeSH terms:
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities