A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty

NCT02634619 | Terminated

• 2 other identifiers: K12DK083021-DvVK12DK083021
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of repairing the strictured urethra. Current evidence suggests the two approaches for placement of the graft are equally successful at correcting the stricture and the two approaches have similar risks of complications. The investigators propose to randomly assign appropriately selected patients to either a dorsally- or ventrally-placed graft. No additional procedures beyond normal care protocol will be required of the patients. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

Conditions

Urethral Stricture

Keywords

urethral stricture

Outcome Measures

Primary Outcomes (1)

• Anatomic recurrence of urethral stricture observed by cystoscopy or RUG/VCUG

  This is defined by the patient as slowing of urinary stream in conjunction with stricture recurrence

  Through study completion, an average of up to 1 year

Secondary Outcomes (8)

• Outcome of perioperative complication deep vein thrombosis (DVT), determined by medical history, physical examination, and/or ultrasound:

  Through study completion, an average of up to 1 year

• Outcome of perioperative complication: positioning complaints

  Through study completion, an average of up to 1 year

• Outcome of perioperative complication perineal abscess, determined through physical or digital examination:

  Through study completion, an average of up to 1 year

• Leak at 2-3 week post-op voiding cystourethrogram (VCUG) to identify if there is any leak at the site of repair

  Observed at 2-3 weeks post-op

• Max urinary flow rate (mL/sec)

  Observed at 3 month post-op & 12 month post-op

Other Outcomes (2)

• Delta Sexual Health Inventory for Men (SHIM) to determinate erectile dysfunction

  Administered at 3 &12 month post op

• Delta Male Sexual Health Questionnaire (MSHQ) to assess sexual function

  Administered at 3 & 12 month post op

Study Arms (2)

Ventral Buccal Mucosa Graft Onlay

ACTIVE COMPARATOR

Standard of care method for repairing urethral strictures

Procedure: Ventral buccal mucosa onlay urethroplasty

Dorsal Buccal Mucosa Graft Onlay

ACTIVE COMPARATOR

Standard of care method for repairing urethral strictures

Procedure: Dorsal buccal mucosa onlay urethroplasty

Interventions

Ventral buccal mucosa onlay urethroplasty PROCEDURE

Ventral buccal graft onlay involves a midline perineal incision and retraction of the bulbospongiosum muscle downward to expose the ventral urethral surface. The corpus spongiosum is incised longitudinally to expose the urethral lumen and the incision is extended proximal and distal to the established stricture. The buccal mucosa graft is harvested and trimmed to the length and width of the urethrotomy and the graft is sutured at the proximal and distal apices and a running suture at the lateral margins to establish a tight anastomosis. Ventral placement allows for limited urethral mobilization and easy access, but there is concern about higher likelihood of diverticulum formation and development of other associated complications - such as post void dribbling and ejaculatory dysfunction.

Ventral Buccal Mucosa Graft Onlay

Dorsal buccal mucosa onlay urethroplasty PROCEDURE

Dorsal buccal onlay also involves a midline perineal incision. The bulbo-cavernosum and corpora cavernosum are dissected from the bulbar urethra allowing for complete mobilization of the urethra. The urethra is rotated 180 degrees to allow for dorsal access and an incision is made on the dorsal urethra proximal and distal to the stricture location. The buccal graft is harvested and trimmed to the appropriate size of the urethrotomy and spread on the overlying tunica albuginea of the corporal bodies. The urethra is rotated back to allow for suturing of the left mucosal margin to the left margin of the buccal graft and corporal bodies, essentially covering the entire urethral plate. Dorsal placement has potential for a more stable vascular bed for graft sustainability and less spongiosal bleeding, but requires a greater urethral mobilization and longer operative times.

Dorsal Buccal Mucosa Graft Onlay

Eligibility Criteria

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

You may qualify if:

• Male ≥ 18 years old with diagnosis of bulbar urethral stricture by voiding cystourethrogram of known and/or idiopathic etiology.
• Male patients with bulbar urethral stricture \> 1 cm in length
• Strictures must predominantly include the proximal and/or mid-bulbar urethra
• Strictures may extend from the mid-bulbar urethra into the distal bulbar urethra

You may not qualify if:

• Patients with prior history of open urethral surgery, such as:
• Prior urethroplasty
• Artificial urniary Sphincter placement
• Male urethral sling placement
• Rectourethral fistula
• Radiation therapy to the abdomen or pelvis
• Patients with previous hypospadias repair
• lichen sclerosis
• no involvement of the pendulous urethra

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Minnesota: collaborator
• Baylor College of Medicine: collaborator
• University of Iowa: collaborator
• University of Kansas: collaborator
• Central Ohio Urology Group: collaborator
• Loyola University Chicago: collaborator
• Lahey Clinic: collaborator
• University of Washington: collaborator
• New York University: collaborator
• University of California, San Diego: collaborator
• University of Utah: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (19)

• Andrich DE, Leach CJ, Mundy AR. The Barbagli procedure gives the best results for patch urethroplasty of the bulbar urethra. BJU Int. 2001 Sep;88(4):385-9. doi: 10.1046/j.1464-410x.2001.02344.x.

  PMID: 11564027 BACKGROUND

• Andrich DE, Mundy AR. Substitution urethroplasty with buccal mucosal-free grafts. J Urol. 2001 Apr;165(4):1131-3; discussion 1133-4.

  PMID: 11257653 BACKGROUND

• Barbagli G, De Stefani S, Sighinolfi MC, Annino F, Micali S, Bianchi G. Bulbar urethroplasty with dorsal onlay buccal mucosal graft and fibrin glue. Eur Urol. 2006 Sep;50(3):467-74. doi: 10.1016/j.eururo.2006.05.018. Epub 2006 Jun 5.

  PMID: 16806665 BACKGROUND

• 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.

  PMID: 16094007 BACKGROUND

• Barbagli G, Palminteri E, Rizzo M. Dorsal onlay graft urethroplasty using penile skin or buccal mucosa in adult bulbourethral strictures. J Urol. 1998 Oct;160(4):1307-9.

  PMID: 9751341 BACKGROUND

• Dubey D, Kumar A, Bansal P, Srivastava A, Kapoor R, Mandhani A, Bhandari M. Substitution urethroplasty for anterior urethral strictures: a critical appraisal of various techniques. BJU Int. 2003 Feb;91(3):215-8. doi: 10.1046/j.1464-410x.2003.03064.x.

  PMID: 12581007 BACKGROUND

• Dubey D, Kumar A, Mandhani A, Srivastava A, Kapoor R, Bhandari M. Buccal mucosal urethroplasty: a versatile technique for all urethral segments. BJU Int. 2005 Mar;95(4):625-9. doi: 10.1111/j.1464-410X.2005.05352.x.

  PMID: 15705092 BACKGROUND

• Elliott SP, Metro MJ, McAninch JW. Long-term followup of the ventrally placed buccal mucosa onlay graft in bulbar urethral reconstruction. J Urol. 2003 May;169(5):1754-7. doi: 10.1097/01.ju.0000057800.61876.9b.

  PMID: 12686826 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

• Heinke T, Gerharz EW, Bonfig R, Riedmiller H. Ventral onlay urethroplasty using buccal mucosa for complex stricture repair. Urology. 2003 May;61(5):1004-7. doi: 10.1016/s0090-4295(02)02523-2.

  PMID: 12736024 BACKGROUND

• Kane CJ, Tarman GJ, Summerton DJ, Buchmann CE, Ward JF, O'Reilly KJ, Ruiz H, Thrasher JB, Zorn B, Smith C, Morey AF. Multi-institutional experience with buccal mucosa onlay urethroplasty for bulbar urethral reconstruction. J Urol. 2002 Mar;167(3):1314-7.

  PMID: 11832721 BACKGROUND

• Kellner DS, Fracchia JA, Armenakas NA. Ventral onlay buccal mucosal grafts for anterior urethral strictures: long-term followup. J Urol. 2004 Feb;171(2 Pt 1):726-9. doi: 10.1097/01.ju.0000103500.21743.89.

  PMID: 14713797 BACKGROUND

• Mangera A, Patterson JM, Chapple CR. A systematic review of graft augmentation urethroplasty techniques for the treatment of anterior urethral strictures. Eur Urol. 2011 May;59(5):797-814. doi: 10.1016/j.eururo.2011.02.010. Epub 2011 Feb 24.

  PMID: 21353379 BACKGROUND

• 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

• 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

• Raber M, Naspro R, Scapaticci E, Salonia A, Scattoni V, Mazzoccoli B, Guazzoni G, Rigatti P, Montorsi F. Dorsal onlay graft urethroplasty using penile skin or buccal mucosa for repair of bulbar urethral stricture: results of a prospective single center study. Eur Urol. 2005 Dec;48(6):1013-7. doi: 10.1016/j.eururo.2005.05.003. Epub 2005 May 31.

  PMID: 15970374 BACKGROUND

• Wang K, Miao X, Wang L, Li H. Dorsal onlay versus ventral onlay urethroplasty for anterior urethral stricture: a meta-analysis. Urol Int. 2009;83(3):342-8. doi: 10.1159/000241680. Epub 2009 Oct 13.

  PMID: 19829038 BACKGROUND

• Wessells H, McAninch JW. Use of free grafts in urethral stricture reconstruction. J Urol. 1996 Jun;155(6):1912-5.

  PMID: 8618286 BACKGROUND

• Xu YM, Qiao Y, Sa YL, Wu DL, Zhang XR, Zhang J, Gu BJ, Jin SB. Substitution urethroplasty of complex and long-segment urethral strictures: a rationale for procedure selection. Eur Urol. 2007 Apr;51(4):1093-8; discussion 1098-9. doi: 10.1016/j.eururo.2006.11.039. Epub 2006 Nov 27.

  PMID: 17157433 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

• benjamin n breyer, MD, MAS, FAC

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Urology

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 18, 2015
• Study Start: June 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)