Clinical trial NCT02634619: A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
Official title: A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urethral Stricture
Keywords: urethral stricture
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Baylor College of Medicine
name: University of Iowa
name: University of Kansas
name: Central Ohio Urology Group
name: Loyola University Chicago
name: Lahey Clinic
name: University of Washington
name: New York University
name: University of California, San Diego
name: University of Utah
First posted: 2015-12-18
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 1. Screening for eligibility; Enrollment/baseline: Patients are referred to UCSF urology clinic for urethroplasty. Participants commonly come to the clinic having already had imaging of their stricture, completed the appropriate PROMs, uroflowmetry and post-void residual urine volume measurement. The patient usually leaves the initial clinic visit with a scheduled surgery. Thus, both screening and enrollment will be done at the initial clinic visit. If the patient agrees to enroll and signs the consent form, they will then be randomized.
2. Randomization: The PI will contact the research assistant by email or telephone and communicate the random identification number of the subject and receive the random assignment to ventral or dorsal graft. This will usually occur after the initial clinic visit but certainly before the surgery date. Patients will not be blinded as to their assignment. Surgeons, out of necessity, will not be blinded as well.
3. Treatment/intervention period: Patient will undergo urethroplasty using standard approach and graft will be placed ventrally or dorsally, as assigned. Most patients go home the same day after surgery. A catheter will be left in the urethra for 2-4 weeks as is standard approach for buccal graft urethroplasties.
4. Follow-up (there will be no extra clinic visits, questionnaires, or tests beyond that which the investigators normally do for all patients undergoing urethroplasty):

   1. 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture line
   2. 3 and 12 months post-operative clinic visit:

   i. cystoscopy ii. PROMs and additional post-operative questionnaires iii. Uroflowmetry and post-void residual urine volume c. Annual visits after year 1: The investigators will typically follow patients annually with no end date after urethroplasty. For publication purposesits has been set to 1 year as the study end date but the investigators will continue to see the patients outside the study protocol after year 1 (so that participants receive the same care as people not in the study) and will perform the following: i. Cystoscopy, if indicated based on abnormalities in ii or iii ii. PROMs and additional post-operative questionnaires iii. Uroflowmetry and post-void residual urine volume
5. Data Safety and Monitoring Both ventral and dorsal buccal mucosa graft are standard of care and all surgeons in this study have performed at least 50-100 of each of these surgeries. Investigators do not anticipate adverse events that are not well known in the literature. Urethroplasty is generally a low risk surgery. Still, any AEs will be monitored by the surgeon and communicated to Dr. Jeremy Myers at The University of Utah, which serves as the coordinating center for this study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anatomic recurrence of urethral stricture observed by cystoscopy or RUG/VCUG
timeFrame: Through study completion, an average of up to 1 year
Secondary outcomes:
measure: Outcome of perioperative complication deep vein thrombosis (DVT), determined by medical history, physical examination, and/or ultrasound:
timeFrame: Through study completion, an average of up to 1 year
measure: Outcome of perioperative complication: positioning complaints
timeFrame: Through study completion, an average of up to 1 year
measure: Outcome of perioperative complication perineal abscess, determined through physical or digital examination:
timeFrame: Through study completion, an average of up to 1 year
measure: Leak at 2-3 week post-op voiding cystourethrogram (VCUG) to identify if there is any leak at the site of repair
timeFrame: Observed at 2-3 weeks post-op
measure: Max urinary flow rate (mL/sec)
timeFrame: Observed at 3 month post-op & 12 month post-op
measure: Intervention rate: catheter self dilation / dilation
timeFrame: Through study completion, an average of up to 1 year
measure: Intervention rate: DVIU
timeFrame: Through study completion, an average of up to 1 year
measure: Intervention rate: repeat urethroplasty
timeFrame: Through study completion, an average of up to 1 year
Other outcomes:
measure: Delta Sexual Health Inventory for Men (SHIM) to determinate erectile dysfunction
timeFrame: Administered at 3 &12 month post op
measure: Delta Male Sexual Health Questionnaire (MSHQ) to assess sexual function
timeFrame: Administered at 3 & 12 month post op
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: benjamin n breyer, MD, MAS, FAC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Andrich DE, Mundy AR. Substitution urethroplasty with buccal mucosal-free grafts. J Urol. 2001 Apr;165(4):1131-3; discussion 1133-4.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
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. doi: 10.1016/s0090-4295(02)02585-2.
citation: 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.
citation: 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.
citation: Wessells H, McAninch JW. Use of free grafts in urethral stricture reconstruction. J Urol. 1996 Jun;155(6):1912-5.
citation: 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.