Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urethral Stricture

Intervention / Treatment
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* Procedure: Labial Graft
* Procedure: Jugal Graft


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success Rate | Absence of surgical intervention after prior surgery | 6 months | 
| Labial Group Success Rate | Absence of surgical intervention after prior surgery on patients who received a labial graft. | 6 months | 
| Jugal Group Success Rate | Absence of surgical intervention after prior surgery on patients who received a inner cheek graft. | 6 months | 
| Latex Catheter Success Rate | Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery. | 6 months | 
| Silicon Catheter Success Rate | 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 | Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups | 24 months | 
| Stricture Localization | Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups | 24 months | 
| Stricture Size | Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups | 24 months | 
| Demographic Data | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urethral stricture, mucosa graft, jugal graft,, labial graft, success rate