Glans Size in Hypospadias Compared to Normal

NCT ID: NCT03593720

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-25

Study Completion Date

2024-12-29

Brief Summary

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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

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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.

Conditions

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Hypospadias Surgery Non Hypospadias

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypospadias

Patients with hypospadias

Measurement in Office

Intervention Type PROCEDURE

Penile length and glans size in 3 dimensions

Measurement in OR

Intervention Type PROCEDURE

Penile length and glans size in 3 dimensions

Control

Patients without hypospadias

Measurement in OR

Intervention Type PROCEDURE

Penile length and glans size in 3 dimensions

Interventions

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Measurement in Office

Penile length and glans size in 3 dimensions

Intervention Type PROCEDURE

Measurement in OR

Penile length and glans size in 3 dimensions

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Barry Kogan, MD

Professor of Surgery and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry Kogan, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

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Albany Medical College

Albany, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24332704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23768835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26320396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24726783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28844754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28939350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29174377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29248308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25837705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27321554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28082769 (View on PubMed)

Other Identifiers

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AMC5152

Identifier Type: -

Identifier Source: org_study_id

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