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Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

Primary Purpose

Urethral Stricture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labial Graft
Jugal Graft
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture focused on measuring urethral stricture, mucosa graft, jugal graft,, labial graft, success rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Labial

    Jugal

    Arm Description

    Patients who received a labial graft as replacement of urethral tissue

    Patients who received a jugal (inner cheek) graft as replacement of urethral tissue

    Outcomes

    Primary Outcome Measures

    Overall Success Rate
    Absence of surgical intervention after prior surgery
    Labial Group Success Rate
    Absence of surgical intervention after prior surgery on patients who received a labial graft.
    Jugal Group Success Rate
    Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
    Latex Catheter Success Rate
    Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
    Silicon Catheter Success Rate
    Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.

    Secondary Outcome Measures

    Stricture Etiology
    Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups
    Stricture Localization
    Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups
    Stricture Size
    Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups
    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

    Full Information

    First Posted
    May 15, 2019
    Last Updated
    August 20, 2020
    Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03973619
    Brief Title
    Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty
    Official Title
    Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    July 31, 2018 (Actual)
    Study Completion Date
    November 27, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre
    Collaborators
    Federal University of Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urethral Stricture
    Keywords
    urethral stricture, mucosa graft, jugal graft,, labial graft, success rate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Labial
    Arm Type
    Active Comparator
    Arm Description
    Patients who received a labial graft as replacement of urethral tissue
    Arm Title
    Jugal
    Arm Type
    Active Comparator
    Arm Description
    Patients who received a jugal (inner cheek) graft as replacement of urethral tissue
    Intervention Type
    Procedure
    Intervention Name(s)
    Labial Graft
    Intervention Description
    As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).
    Intervention Type
    Procedure
    Intervention Name(s)
    Jugal Graft
    Intervention Description
    As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).
    Primary Outcome Measure Information:
    Title
    Overall Success Rate
    Description
    Absence of surgical intervention after prior surgery
    Time Frame
    6 months
    Title
    Labial Group Success Rate
    Description
    Absence of surgical intervention after prior surgery on patients who received a labial graft.
    Time Frame
    6 months
    Title
    Jugal Group Success Rate
    Description
    Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
    Time Frame
    6 months
    Title
    Latex Catheter Success Rate
    Description
    Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
    Time Frame
    6 months
    Title
    Silicon Catheter Success Rate
    Description
    Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Stricture Etiology
    Description
    Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups
    Time Frame
    24 months
    Title
    Stricture Localization
    Description
    Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups
    Time Frame
    24 months
    Title
    Stricture Size
    Description
    Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups
    Time Frame
    24 months
    Title
    Demographic Data
    Description
    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
    Time Frame
    24 months

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brasil S Neto, Phd MD
    Organizational Affiliation
    Hospital de Clinicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16094007
    Citation
    Barbagli G, Palminteri E, Guazzoni G, Montorsi F, Turini D, Lazzeri M. Bulbar urethroplasty using buccal mucosa grafts placed on the ventral, dorsal or lateral surface of the urethra: are results affected by the surgical technique? J Urol. 2005 Sep;174(3):955-7; discussion 957-8. doi: 10.1097/01.ju.0000169422.46721.d7.
    Results Reference
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    PubMed Identifier
    8753728
    Citation
    Morey AF, McAninch JW. When and how to use buccal mucosal grafts in adult bulbar urethroplasty. Urology. 1996 Aug;48(2):194-8. doi: 10.1016/S0090-4295(96)00154-9.
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    Citation
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    PubMed Identifier
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    Citation
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    Citation
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    Barbagli G, Palminteri E, Lazzeri M, Guazzoni G, Turini D. Long-term outcome of urethroplasty after failed urethrotomy versus primary repair. J Urol. 2001 Jun;165(6 Pt 1):1918-9. doi: 10.1097/00005392-200106000-00018.
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    Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

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