NCT02497963

Brief Summary

The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

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

June 25, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

June 25, 2015

Last Update Submit

July 14, 2015

Conditions

Hypospadias

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with complications as a measure of safety

    Fourth month after surgery

Secondary Outcomes (3)

  • Proportion of participants with fistula as a measure of safety

    Fourth month after surgery

  • Proportion of participants with stricture as a measure of safety

    Fourth month after surgery

  • Proportion of participants with breakdown as a measure of safety

    Fourth month after surgery

Other Outcomes (2)

  • Degree of Cosmetic by HOPE Score as a measure of efficacy

    Fourth and sixth months after suregry

  • Urinary mean flow by uroflowmeter as a measure of efficacy

    Fourth and sixth months after surgery

Study Arms (2)

Foreskin Graft-Tubularized Incised Plate

EXPERIMENTAL

Group of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter.

Procedure: Foreskin Graft-Tubularized Incised Plate

Tubularized Incised Plate

ACTIVE COMPARATOR

Group of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter.

Procedure: Tubularized Incised Plate

Interventions

Foreskin Graft-Tubularized Incised PlatePROCEDURE

TIP Urethroplasty with foreskin graft in primary hypospadias

Foreskin Graft-Tubularized Incised Plate
Tubularized Incised PlatePROCEDURE

TIP Urethroplasty without foreskin graft in primary hypospadias

Tubularized Incised Plate

Eligibility Criteria

Age3 Months - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients diagnosed with hypospadias without previous surgery
  • Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

You may not qualify if:

  • Patients diagnosed with hypospadias and severe psychomotor development delay
  • Patients with disorders of sexual development without gender assignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Snodgrass WT. Re: Effect of suturing technique and urethral plate characteristics on complication rate following hypospadias repair: a prospective randomized study O. Sarhan, M. Saad, T. Helmy and A. Hafez J Urol 2009; 182: 682-686. J Urol. 2010 Apr;183(4):1649-50; discussion 1650. doi: 10.1016/j.juro.2009.12.048. Epub 2010 Mar 4. No abstract available.

    PMID: 20206364BACKGROUND

  • Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. doi: 10.1016/s0022-5347(17)34991-1.

    PMID: 8283561RESULT

  • Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3.

    PMID: 10799234RESULT

  • Holland AJ, Smith GH. Effect of the depth and width of the urethral plate on tubularized incised plate urethroplasty. J Urol. 2000 Aug;164(2):489-91.

    PMID: 10893631RESULT

  • Mouravas V, Filippopoulos A, Sfoungaris D. Urethral plate grafting improves the results of tubularized incised plate urethroplasty in primary hypospadias. J Pediatr Urol. 2014 Jun;10(3):463-8. doi: 10.1016/j.jpurol.2013.11.012. Epub 2013 Dec 10.

    PMID: 24360521RESULT

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 Officials

  • Mario E Rendón Macías, MD MsC

    CMNXXI, IMSS

    STUDY CHAIR

  • Onofre Muñoz Hernández, MD MsC

    Hospital Infantil de Mexico Federico Gomez

    STUDY DIRECTOR

Central Study Contacts

Byron A Pacheco Mendoza, MD MsC

CONTACT

+525544378709byronpachecom@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MsC, Pediatric Urologist,

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 15, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

July 15, 2015

Record last verified: 2015-07