Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973619
• Other study ID #: 170319
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: November 27, 2018

Study information

• Verified date: August 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 27, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Procedure:
• Labial Graft
As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).
• Jugal Graft
As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

References & Publications (15)

Akyüz M, Günes 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Bracka A. A versatile two-stage hypospadias repair. Br J Plast Surg. 1995 Sep;48(6):345-52. — View Citation

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. — View Citation

Fichtner J, Filipas D, Fisch M, Hohenfellner R, Thüroff JW. Long-term outcome of ventral buccal mucosa onlay graft urethroplasty for urethral stricture repair. Urology. 2004 Oct;64(4):648-50. Review. — View Citation

Martínez-Piñeiro JA, Martínez-Piñeiro L, Tabernero A. [Substitution urethroplasties with free graft buccal mucosa]. Arch Esp Urol. 1998 Sep;51(7):645-59. Spanish. — View Citation

Morey AF, McAninch JW. When and how to use buccal mucosal grafts in adult bulbar urethroplasty. Urology. 1996 Aug;48(2):194-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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