NCT03911635

Brief Summary

Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations \[1\]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias \[2\]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty \" URAGPI\" versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion. B) Normal appearance of the penis. C) Good functional results.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

March 23, 2019

Last Update Submit

January 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks

    evaluation according to "Hypospadias Objective Penile Evaluation Score"

    3 weeks

Study Arms (1)

Hypospadias in children

EXPERIMENTAL

Distal shaft hypospadias at age of 12 years or less

Procedure: URAGPI technique

Interventions

the Urethral Advancement, Glanuloplasty and Preputioplasty

Hypospadias in children

Eligibility Criteria

Age1 Year - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al

You may not qualify if:

  • circumcised patients
  • sever degrees of chordae
  • previous surgical repair
  • meatal stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2019

First Posted

April 11, 2019

Study Start

April 1, 2020

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

January 9, 2020

Record last verified: 2020-01