Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03593720
Status:
COMPLETED
Last Update Posted:
2025-10-31
First Post:
2018-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glans Size in Hypospadias Compared to Normal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D000092922', 'term': 'Working Conditions'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017132', 'term': 'Workplace'}, {'id': 'D004651', 'term': 'Employment'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D010559', 'term': 'Personnel Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in glans size between hypospadias patients and those without hypospadias', 'timeFrame': '6 months', 'description': 'The investigator will prospectively collect data on glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery'}], 'secondaryOutcomes': [{'measure': 'Difference in penile length between hypospadias patients and those without hypospadias', 'timeFrame': '6 months', 'description': 'The investigator will prospectively collect data on penis length by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery'}, {'measure': 'Track penile and glans growth curves in both cohorts', 'timeFrame': '24 months', 'description': 'The investigator will prospectively track penile and glans growth over time to develop longitudinal growth curves in both cohorts'}, {'measure': 'Determine the effect of testosterone on penile and glans growth in hypospadias', 'timeFrame': '24 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypaspadias'], 'conditions': ['Hypospadias', 'Surgery Non Hypospadias']}, 'referencesModule': {'references': [{'pmid': '24332704', 'type': 'BACKGROUND', 'citation': 'Babu R. Glans meatus proportion in hypospadias versus normal: does marking reference points impact outcome? J Pediatr Urol. 2014 Jun;10(3):459-62. doi: 10.1016/j.jpurol.2013.11.008. Epub 2013 Nov 28.'}, {'pmid': '23768835', 'type': 'BACKGROUND', 'citation': 'Bush NC, DaJusta D, Snodgrass WT. Glans penis width in patients with hypospadias compared to healthy controls. J Pediatr Urol. 2013 Dec;9(6 Pt B):1188-91. doi: 10.1016/j.jpurol.2013.05.004. Epub 2013 Jun 12.'}, {'pmid': '26320396', 'type': 'BACKGROUND', 'citation': 'Bush NC, Villanueva C, Snodgrass W. Glans size is an independent risk factor for urethroplasty complications after hypospadias repair. J Pediatr Urol. 2015 Dec;11(6):355.e1-5. doi: 10.1016/j.jpurol.2015.05.029. Epub 2015 Aug 13.'}, {'pmid': '24726783', 'type': 'BACKGROUND', 'citation': 'Malik RD, Liu DB. Survey of pediatric urologists on the preoperative use of testosterone in the surgical correction of hypospadias. J Pediatr Urol. 2014 Oct;10(5):840-3. doi: 10.1016/j.jpurol.2014.02.008. Epub 2014 Mar 18.'}, {'pmid': '28844754', 'type': 'BACKGROUND', 'citation': 'Babu R, Chakravarthi S. The role of preoperative intra muscular testosterone in improving functional and cosmetic outcomes following hypospadias repair: A prospective randomized study. J Pediatr Urol. 2018 Feb;14(1):29.e1-29.e6. doi: 10.1016/j.jpurol.2017.07.009. Epub 2017 Aug 12.'}, {'pmid': '28939350', 'type': 'BACKGROUND', 'citation': 'Chua ME, Gnech M, Ming JM, Silangcruz JM, Sanger S, Lopes RI, Lorenzo AJ, Braga LH. Preoperative hormonal stimulation effect on hypospadias repair complications: Meta-analysis of observational versus randomized controlled studies. J Pediatr Urol. 2017 Oct;13(5):470-480. doi: 10.1016/j.jpurol.2017.06.019. Epub 2017 Jul 29.'}, {'pmid': '29174377', 'type': 'BACKGROUND', 'citation': 'Rynja SP, de Jong TPVM, Bosch JLHR, de Kort LMO. Testosterone prior to hypospadias repair: Postoperative complication rates and long-term cosmetic results, penile length and body height. J Pediatr Urol. 2018 Feb;14(1):31.e1-31.e8. doi: 10.1016/j.jpurol.2017.09.020. Epub 2017 Oct 27.'}, {'pmid': '29248308', 'type': 'BACKGROUND', 'citation': 'Van Praet C, Spinoit AF. Testosterone prior to hypospadias repair: No clear-cut benefit or reassurance regarding long-term safety. J Pediatr Urol. 2018 Feb;14(1):85-86. doi: 10.1016/j.jpurol.2017.11.006. Epub 2017 Nov 27. No abstract available.'}, {'pmid': '25837705', 'type': 'BACKGROUND', 'citation': 'Asgari SA, Safarinejad MR, Poorreza F, Asl AS, Ghanaie MM, Shahab E. The effect of parenteral testosterone administration prior to hypospadias surgery: A prospective, randomized and controlled study. J Pediatr Urol. 2015 Jun;11(3):143.e1-6. doi: 10.1016/j.jpurol.2014.12.014. Epub 2015 Mar 12.'}, {'pmid': '27321554', 'type': 'BACKGROUND', 'citation': 'Paiva KC, Bastos AN, Miana LP, Barros Ede S, Ramos PS, Miranda LM, Faria NM, Avarese de Figueiredo A, de Bessa J Jr, Netto JM. Biometry of the hypospadic penis after hormone therapy (testosterone and estrogen): A randomized, double-blind controlled trial. J Pediatr Urol. 2016 Aug;12(4):200.e1-6. doi: 10.1016/j.jpurol.2016.04.013. Epub 2016 May 26.'}, {'pmid': '28082769', 'type': 'BACKGROUND', 'citation': 'Puri A, Sikdar S, Prakash R. Pediatric Penile and Glans Anthropometry Nomograms: An Aid in Hypospadias Management. J Indian Assoc Pediatr Surg. 2017 Jan-Mar;22(1):9-12. doi: 10.4103/0971-9261.194610.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nControl 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery for hypospadias\n* Patients undergoing any urologic surgery other than hypospadias\n\nExclusion Criteria:\n\n* other penile abnormalities (Hidden penis, penoscrotal wedding/transposition, chordee without hypospadias, penile torsion, etc.)\n* Undergoing other penile procedures (penoplasty, chordee repair, penile detorsion, etc.)'}, 'identificationModule': {'nctId': 'NCT03593720', 'briefTitle': 'Glans Size in Hypospadias Compared to Normal', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Glans Size in Hypospadias Compared to Normal', 'orgStudyIdInfo': {'id': 'AMC5152'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypospadias', 'description': 'Patients with hypospadias', 'interventionNames': ['Procedure: Measurement in Office', 'Procedure: Measurement in OR']}, {'label': 'Control', 'description': 'Patients without hypospadias', 'interventionNames': ['Procedure: Measurement in OR']}], 'interventions': [{'name': 'Measurement in Office', 'type': 'PROCEDURE', 'description': 'Penile length and glans size in 3 dimensions', 'armGroupLabels': ['Hypospadias']}, {'name': 'Measurement in OR', 'type': 'PROCEDURE', 'description': 'Penile length and glans size in 3 dimensions', 'armGroupLabels': ['Control', 'Hypospadias']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Barry Kogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Pediatrics', 'investigatorFullName': 'Barry Kogan, MD', 'investigatorAffiliation': 'Albany Medical College'}}}}