NCT04946058

Brief Summary

the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

March 31, 2012

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

8.8 years

First QC Date

June 16, 2021

Last Update Submit

June 22, 2021

Conditions

Distal Penile Hypospadias (Disorder)

Keywords

distal hypospadiasMathieu urethroplastymodifiedurethral plate

Outcome Measures

Primary Outcomes (2)

  • successful treatment of distal penile hypospadias

    use of HOSE as a measure o success o repair

    6 moths post operative

  • increase the scope of classic Mathieu urethroplasty

    cases with glanular width from 10 mm to 15 mm were included

    6 months post operative

Interventions

hyebrid Mathieu UrethroplastyPROCEDURE

incision of the urethral plate during the procedure

Eligibility Criteria

Age6 Months - 4 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsall male infants and children suffering from distal penile hypospadias
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • distal penile hypospadias

You may not qualify if:

  • sever hypospadias
  • cases need redo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Assistant professor of pediatric surgery

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 30, 2021

Study Start

March 31, 2012

Primary Completion

December 31, 2020

Study Completion

January 15, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06