Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

August 20, 2020 updated by: Rafael Carvalho Ipe da Silva, Hospital de Clinicas de Porto Alegre

Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty

Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. This paper aims to evaluate the success rate of this treatment after randomized choice between labial and jugal (inner cheek) grafts during the past two years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Free dorsal graft urethroplasty, first described by Barbagli et al, has been shown better results than ventral grafts. Fixed grafts on the corpora cavernosa results in a better mechanical support and vascular supply, with less chance to complications such as pseudodiverticula and sacculations either a better urethral phisiology.

This study aims to evaluate the current surgical management in our centre: buccal mucosa graft urethroplasty with jugal or labial replacement, comparing their group success rate and complications between the groups in patients led to surgery from October 2016 to June 2018.

Prospective analysis from urethral stricture surgical HCPA patient data by dorsal buccal mucosa graft urethroplasty. The graft choice were done by a software. Longer stricture with transoperative need for the two grafts use were excluded. Success rate were measured with a no stricture de novo or absence of complications in a six month interval.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Urethral Stricture Diagnosis
  • Indication for buccal mucosa graft urethroplasty
  • Accept the Informed Consent Term (patient or responsible)

Exclusion Criteria:

  • Severe urethral stricture which a two-staged procedure are required
  • Long strictures which need a both types of buccal mucosa graft due its length.
  • Refuse to ICT for the patient ou it responsible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Labial
Patients who received a labial graft as replacement of urethral tissue
Procedure: Labial Graft
As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).
Active Comparator: Jugal
Patients who received a jugal (inner cheek) graft as replacement of urethral tissue
Procedure: Jugal Graft
As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success Rate
Time Frame: 6 months
Absence of surgical intervention after prior surgery
6 months
Labial Group Success Rate
Time Frame: 6 months
Absence of surgical intervention after prior surgery on patients who received a labial graft.
6 months
Jugal Group Success Rate
Time Frame: 6 months
Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
6 months
Latex Catheter Success Rate
Time Frame: 6 months
Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
6 months
Silicon Catheter Success Rate
Time Frame: 6 months
Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stricture Etiology
Time Frame: 24 months
Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups
24 months
Stricture Localization
Time Frame: 24 months
Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups
24 months
Stricture Size
Time Frame: 24 months
Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups
24 months
Demographic Data
Time Frame: 24 months
Evaluation of the demographic data relationship with the results (age, cystotomy, cystostomy time, tobacco use, diabetes, balanitis xerotica, UTI infection, serum creatin levels) included on Labial and Jugal groups
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Brasil S Neto, Phd MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

November 27, 2018

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

June 2, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urethral Stricture

Clinical Trials on Labial Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe