Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

NCT03973619 | Completed

• 1 other identifier: 170319
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urethral Stricture

Keywords

urethral stricture; mucosa graft; jugal graft,; labial graft; success rate

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Stricture Etiology

  24 months

• Stricture Localization

  24 months

• Stricture Size

  24 months

• Demographic Data

  24 months

Study Arms (2)

Labial

ACTIVE COMPARATOR

Patients who received a labial graft as replacement of urethral tissue

Procedure: Labial Graft

Jugal

ACTIVE COMPARATOR

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

Procedure: Jugal Graft

Interventions

Labial Graft PROCEDURE

As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).

Labial

Jugal Graft PROCEDURE

As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).

Jugal

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Related Publications (15)

• 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.

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• Bracka A. A versatile two-stage hypospadias repair. Br J Plast Surg. 1995 Sep;48(6):345-52. doi: 10.1016/s0007-1226(95)90023-3.

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• 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.

  PMID: 8753728 BACKGROUND

• Palminteri E, Lumen N, Berdondini E, Di Pierro GB, Cucchiarale G, Tenti G, De Nunzio C. Two-sided dorsal plus ventral oral graft bulbar urethroplasty: long-term results and predictive factors. Urology. 2015 Apr;85(4):942-7. doi: 10.1016/j.urology.2015.01.013.

  PMID: 25817122 BACKGROUND

• Pansadoro V, Emiliozzi P, Gaffi M, Scarpone P, DePaula F, Pizzo M. Buccal mucosa urethroplasty in the treatment of bulbar urethral strictures. Urology. 2003 May;61(5):1008-10. doi: 10.1016/s0090-4295(02)02585-2.

  PMID: 12736025 BACKGROUND

• Sharma AK, Chandrashekar R, Keshavamurthy R, Nelvigi GG, Kamath AJ, Sharma S, Venkatesh GK. Lingual versus buccal mucosa graft urethroplasty for anterior urethral stricture: a prospective comparative analysis. Int J Urol. 2013 Dec;20(12):1199-203. doi: 10.1111/iju.12158. Epub 2013 Apr 21.

  PMID: 23601029 BACKGROUND

• 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.

  PMID: 11371881 BACKGROUND

• Martinez-Pineiro JA, Martinez-Pineiro L, Tabernero A. [Substitution urethroplasties with free graft buccal mucosa]. Arch Esp Urol. 1998 Sep;51(7):645-59. Spanish.

  PMID: 9807890 BACKGROUND

• Barbagli G, Pellegrini G, Corradini F, Montorsi F, Sansalone S, Butnaru D, Lazzeri M. One-stage Penile Urethroplasty Using Oral Mucosal Graft and Glue. Eur Urol. 2016 Dec;70(6):1069-1075. doi: 10.1016/j.eururo.2016.04.025. Epub 2016 May 6.

  PMID: 27160949 BACKGROUND

• Aldaqadossi H, El Gamal S, El-Nadey M, El Gamal O, Radwan M, Gaber M. Dorsal onlay (Barbagli technique) versus dorsal inlay (Asopa technique) buccal mucosal graft urethroplasty for anterior urethral stricture: a prospective randomized study. Int J Urol. 2014 Feb;21(2):185-8. doi: 10.1111/iju.12235. Epub 2013 Aug 12.

  PMID: 23931150 BACKGROUND

• Fichtner J, Filipas D, Fisch M, Hohenfellner R, Thuroff JW. Long-term outcome of ventral buccal mucosa onlay graft urethroplasty for urethral stricture repair. Urology. 2004 Oct;64(4):648-50. doi: 10.1016/j.urology.2004.05.011.

  PMID: 15491691 BACKGROUND

• Asopa HS, Garg M, Singhal GG, Singh L, Asopa J, Nischal A. Dorsal free graft urethroplasty for urethral stricture by ventral sagittal urethrotomy approach. Urology. 2001 Nov;58(5):657-9. doi: 10.1016/s0090-4295(01)01377-2.

  PMID: 11711331 BACKGROUND

• Akyuz M, Gunes M, Koca O, Sertkaya Z, Kanberoglu H, Karaman MI. Evaluation of intraoral complications of buccal mucosa graft in augmentation urethroplasty. Turk J Urol. 2014 Sep;40(3):156-60. doi: 10.5152/tud.2014.46343.

  PMID: 26328170 BACKGROUND

• Barbagli G, Vallasciani S, Romano G, Fabbri F, Guazzoni G, Lazzeri M. Morbidity of oral mucosa graft harvesting from a single cheek. Eur Urol. 2010 Jul;58(1):33-41. doi: 10.1016/j.eururo.2010.01.012. Epub 2010 Jan 19.

  PMID: 20106587 BACKGROUND

• Elbaz J, Le Long E, Dugardin F, Sibert L, Peron JM. [Buccal mucosal graft for the treatment of urethral stricture]. Ann Chir Plast Esthet. 2012 Dec;57(6):626-9. doi: 10.1016/j.anplas.2010.09.008. Epub 2010 Oct 14. French.

  PMID: 20950921 BACKGROUND

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Brasil S Neto, Phd MD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: June 4, 2019
• Study Start: October 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: November 27, 2018
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share