Urethral StrictureDvVNCT02634619
A Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
A study testing Ventral buccal mucosa onlay urethroplasty and Dorsal buccal mucosa onlay urethroplasty in people with Urethral Stricture, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Ventral buccal mucosa onlay urethroplasty and Dorsal buccal mucosa onlay urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with previous hypospadias repair
- lichen sclerosis
- no involvement of the pendulous urethra
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
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.
Read the detailed description
- 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.
- 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.
- 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.
- Follow-up (there will be no extra clinic visits, questionnaires, or tests beyond that which the investigators normally do for all patients undergoing urethroplasty):
- 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture line
- 3 and 12 months post-operative clinic visit:
- 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
- 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.
- Conditions
- Urethral Stricture
- Being tested
- Ventral buccal mucosa onlay urethroplasty, Dorsal buccal mucosa onlay urethroplasty
- Keywords
- urethral stricture
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral buccal mucosa onlay urethroplastyProcedure or surgery
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.
Dorsal buccal mucosa onlay urethroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ventral Buccal Mucosa Graft Onlay | Active comparator | Standard of care method for repairing urethral strictures Receives: Procedure: Ventral buccal mucosa onlay urethroplasty |
| Dorsal Buccal Mucosa Graft Onlay | Active comparator | Standard of care method for repairing urethral strictures Receives: Procedure: Dorsal buccal mucosa onlay urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
DVT occurs when a blood clot forms in one or more of the deep veins in your body, typically in the legs, and carries with it significant morbidity. Determination is based on medical history (overall health, medications, recent surgery, etc.), physical examination for signs of DVT, and if needed, diagnostic tests such as ultrasound.
Measured: Through study completion, an average of up to 1 year
Outcome of perioperative complication: positioning complaints
In order to do the operation, patients are placed in an exaggerated lithotomy position that may cause nerve injury or muscle soreness
Measured: Through study completion, an average of up to 1 year
Outcome of perioperative complication perineal abscess, determined through physical or digital examination:
Perineal abscess is an infectious complication that develops after bacteria overgown and form a collection of pus. Often this will require surgical drainage
Measured: 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
After 2-3 weeks, patients will return to have their Foley catheters removed. At this time, we will perform a voiding cystourethrogram (vcug) to identify if there is any leak at the site of repair. We can see this leak by injecting contrast dye.
Measured: Observed at 2-3 weeks post-op
Max urinary flow rate (mL/sec)
Maximal milliliters per seconds that the patient can urinate
Measured: Observed at 3 month post-op & 12 month post-op
Intervention rate: catheter self dilation / dilation
Patients will occasionally perform self dilation with a catheter to keep their stricture patent after surgery.
Measured: Through study completion, an average of up to 1 year
Intervention rate: DVIU
Stricture recurrence that causes severe restriction in urinary flow may require a direct visual internal urethrotomy (DVIU) following urethroplasty. DVIU is the repair of a narrow segment (stricture) of the urethra. A small scope is placed into the urethra, and a cut is made to repair the stricture.
Measured: Through study completion, an average of up to 1 year
Intervention rate: repeat urethroplasty
Stricture recurrence that causes severe restriction in urinary flow may require a repeat urethroplasty
Measured: Through study completion, an average of up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionNov 2018
- Study completionNov 2018
Why it stopped: Patient enrollment was slow and we were not able to accrue participants at a decent pace.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine, University of Iowa, University of Kansas, Central Ohio Urology Group, Loyola University Chicago, Lahey Clinic, University of Washington, New York University, University of California, San Diego, University of Utah
- Responsible party
- Principal investigator, Benjamin Breyer, MD, University of California, San Francisco
- Investigators
- benjamin n breyer, MD, MAS, FAC, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634619
- Sponsor's protocol ID
- K12DK083021-DvV
- Other IDs
- K12DK083021
- Acronym
- DvV
- Status last verified
- Apr 2019
- First submitted
- 17 Nov 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11564027Andrich DE, Mundy AR. Substitution urethroplasty with buccal mucosal-free grafts. J Urol. 2001 Apr;165(4):1131-3; discussion 1133-4.
PubMed 11257653Barbagli 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.
PubMed 16806665Barbagli 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.
PubMed 16094007Barbagli 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.
PubMed 9751341Dubey 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.
PubMed 12581007Dubey 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.
PubMed 15705092Elliott 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.
PubMed 12686826Fichtner 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.
PubMed 15491691Heinke 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.
PubMed 12736024Kane 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.
PubMed 11832721Kellner 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.
PubMed 14713797Mangera 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.
PubMed 21353379Morey 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.
PubMed 8753728Pansadoro 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.
PubMed 12736025
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
- ClinicalTrials.gov ID
- NCT02634619
- Acronym / sponsor ID
- DvV / K12DK083021-DvV
- Conditions
- Urethral Stricture
- Keywords
- urethral stricture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrollment was slow and we were not able to accrue participants at a decent pace.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine, University of Iowa, University of Kansas, Central Ohio Urology Group, Loyola University Chicago, Lahey Clinic, University of Washington, New York University, University of California, San Diego, University of Utah
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- Follow-up (there will be no extra clinic visits, questionnaires, or tests beyond that which the investigators normally do for all patients undergoing urethroplasty):
- 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture line
- 3 and 12 months post-operative clinic visit:
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventral Buccal Mucosa Graft Onlay | Active comparator | Procedure: Ventral buccal mucosa onlay urethroplastyStandard of care method for repairing urethral strictures |
| Dorsal Buccal Mucosa Graft Onlay | Active comparator | Procedure: Dorsal buccal mucosa onlay urethroplastyStandard of care method for repairing urethral strictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with prior history of open urethral surgery, such as:
- Radiation therapy to the abdomen or pelvis
- Patients with previous hypospadias repair
- lichen sclerosis
- no involvement of the pendulous urethra
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventral buccal mucosa onlay urethroplastyVentral 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. | Procedure or surgery | Ventral Buccal Mucosa Graft Onlay |
| Dorsal buccal mucosa onlay urethroplastyDorsal 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. | Procedure or surgery | Dorsal Buccal Mucosa Graft Onlay |
Primary outcome
Anatomic recurrence of urethral stricture observed by cystoscopy or RUG/VCUG
Time frame: Through study completion, an average of up to 1 year
This is defined by the patient as slowing of urinary stream in conjunction with stricture recurrence
8 secondary outcomes
Outcome of perioperative complication deep vein thrombosis (DVT), determined by medical history, physical examination, and/or ultrasound:
Time frame: Through study completion, an average of up to 1 year
Outcome of perioperative complication: positioning complaints
Time frame: Through study completion, an average of up to 1 year
Outcome of perioperative complication perineal abscess, determined through physical or digital examination:
Time frame: 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
Time frame: Observed at 2-3 weeks post-op
Max urinary flow rate (mL/sec)
Time frame: Observed at 3 month post-op & 12 month post-op
Intervention rate: catheter self dilation / dilation
Time frame: Through study completion, an average of up to 1 year
Intervention rate: DVIU
Time frame: Through study completion, an average of up to 1 year
Intervention rate: repeat urethroplasty
Time frame: Through study completion, an average of up to 1 year
Results and safety
The study was stopped early (reason given: Patient enrollment was slow and we were not able to accrue participants at a decent pace.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Background: PubMed 11564027Andrich 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.
- Background: PubMed 11257653Andrich DE, Mundy AR. Substitution urethroplasty with buccal mucosal-free grafts. J Urol. 2001 Apr;165(4):1131-3; discussion 1133-4.
- Background: PubMed 16806665Barbagli 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.
- Background: PubMed 16094007Barbagli 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.
- Background: PubMed 9751341Barbagli 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.
- Background: PubMed 12581007Dubey 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.
- Background: PubMed 15705092Dubey 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.
- Background: PubMed 12686826Elliott 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.
- Background: PubMed 15491691Fichtner 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.
- Background: PubMed 12736024Heinke 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.
- Background: PubMed 11832721Kane 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.
- Background: PubMed 14713797Kellner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
benjamin n breyer, MD, MAS, FAC principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventral buccal mucosa onlay urethroplasty and Dorsal buccal mucosa onlay urethroplasty in people with Urethral Stricture, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient enrollment was slow and we were not able to accrue participants at a decent pace.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic recurrence of urethral stricture observed by cystoscopy or RUG/VCUG (time frame: Through study completion, an average of up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634619, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.