Glans Size in Hypospadias Compared to Normal

Hypospadias Clinical Trial

Official title:

Glans Size in Hypospadias Compared to Normal

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03593720
• Other study ID #: AMC5152
• Status: Enrolling by invitation
• Start date: July 25, 2018
• Est. completion date: December 29, 2023

Study information

• Verified date: March 2023
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Hypospadias
• Surgery Non Hypospadias

Intervention

Procedure:
• Measurement in Office
Penile length and glans size in 3 dimensions
• Measurement in OR
Penile length and glans size in 3 dimensions

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in glans size between hypospadias patients and those without hypospadias	The investigator will prospectively collect data on glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery	6 months
Secondary	Difference in penile length between hypospadias patients and those without hypospadias	The investigator will prospectively collect data on penis length by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery	6 months
Secondary	Track penile and glans growth curves in both cohorts	The investigator will prospectively track penile and glans growth over time to develop longitudinal growth curves in both cohorts	24 months
Secondary	Determine the effect of testosterone on penile and glans growth in hypospadias	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.	24 months