Urethral StrictureDoVeBuGNCT02551783
Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft
A study testing Urethroplasty with buccal mucosa graft and Ventral Buccal in people with Urethral Stricture, run by University of Minnesota at 1 site in United States.
Trial summary
This is 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 to 85 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Urethroplasty with buccal mucosa graft and Ventral Buccal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 1 Mar 2019
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Strictures must predominantly include the proximal and/or mid bulbar urethra and be otherwise amenable to buccal graft onlay urethroplasty
- Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra within the scrotum, but not through the scrotum to the pendulous junction
- Subjects able to consent for themselves
Who cannot join
- prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter placement, male urethral sling placement, and rectourethral fistula
- radiation therapy to the pelvis
- previous hypospadias repair
- lichen sclerosis unable to consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
This is 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 the 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
Urethral strictures affect 1% of men and are rare in women. Most urethral strictures in the United States develop in the bulbar section of the urethra which is the section of the urethra proximal to the penis but distal to the prostate. A common method of surgical correction is to longitudinally open the strictured urethra and augment its width by the addition of a graft of buccal mucosa taken from the oral cavity. The urethrotomy for placement of the graft can be made along the superficial (ventral) or deep (dorsal) side of the urethra. The graft bed dorsally is the tunica albuginea of the corporal bodies (the capsule around the erectile bodies of the penis) whereas ventrally it is the corpus spongiosum of the urethra (the vascular layer that surrounds the urethra).
Ventral buccal graft onlay first described by Morey and McAninch in 1996, involves a midline perineal incision and retraction of the bulbo-spongiosum 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 associated complications such as post-void dribbling and ejaculatory dysfunction. In addition, many surgeons have concern about graft contraction as spread-fixating the graft is not possible.
Dorsal buccal graft onlay, first described by Barbagli in 1996, 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 right mucosal margin of the urethra is sutured to the right margin of the buccal graft and 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 potentially allows for a more stable vascular bed for graft sustainability and less spongiosal bleeding, but requires a greater urethral mobilization and longer operative times. The technical challenge of graft placement in a dorsal location is much greater than placement ventrally. Potential problems with dorsal placement include damage to the male external urinary sphincter, which is dorsally located, and anastomotic leakage and perineal abscess in the immediate post-operative period.
There are multiple studies that attempt to compare the outcomes of ventral versus dorsal graft placement for bulbar urethroplasty, but these studies rely on case series and retrospective data. Andrich and Mundy reported better outcomes with dorsal buccal placement, but statistical significance was not formally established. Both Barbagli and Figler were unable to demonstrate superiority of either ventral or dorsal buccal graft placement. Currently there is no high level of definitive randomized evidence to suggest superiority of either ventral or dorsal buccal placement in terms of patient outcomes and complications. In fact, the best level of evidence is VI (small case series) and dorsal vs. ventral placement is largely dependent on individual clinical judgment and comfort level with each procedure.
One factor contributing to the inability to detect a difference between dorsal vs. ventral graft placement has been the liberal definition of success that leads to uniformly high success rates across studies (85-95%) and, hence, studies that are underpowered to detect a difference in success rates. In these studies, the definition of success has typically been "need for repeat surgery". Such a definition suffers from significant detection bias in that (1) subclinical stricture recurrences may go undetected if they are not screened for; and (2) surgeon or patient reluctance to undergo a repeat surgery may lead to false negatives. When patients are rigorously followed with endoscopic inspection of the area of surgery with cystoscopy, narrowing is often identified at a much higher rate than "need for repeat surgery". For instance, in a preliminary review of our retrospective data using surveillance cystoscopy, the investigators detected narrowing in 46% of ventral buccal patients and approximately 18% of dorsal buccal patients. This more strict definition of success and the lower success rates that follow may allow for detection of a clinically meaningful difference in the success rate with the two procedures in a reasonably-sized clinical trial.
The investigators plan a randomized comparison of dorsally-placed vs. ventrally-placed buccal mucosa graft in men undergoing buccal graft urethroplasty for bulbar urethra stricture. A collaborative multi-institutional study deriving data from the Trauma and Urologic Reconstruction Network of Surgeons, a network of twelve reconstructive urology centers in the United States, would allow the investigators to achieve the required sample size within 2-3 years. The results of this study will ultimately advance research efforts in urethral stricture management and provide substantial evidence for utilization of ventral versus dorsal buccal placement for reconstructive urologists.
- Conditions
- Urethral Stricture
- Being tested
- Urethroplasty with buccal mucosa graft, Ventral Buccal
- Keywords
- urethral stricture, urethroplasty, buccal mucosa, graft
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethroplasty with buccal mucosa graftProcedure or surgery
A surgery to correct urethral stricture
Ventral BuccalProcedure or surgery
Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Urethroplasty with buccal mucosa graft | Experimental | Intervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the dorsal wall of the urethra. Receives: Procedure: Urethroplasty with buccal mucosa graft |
| Ventral Buccal | Active comparator | Intervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra. Receives: Procedure: Ventral Buccal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of anatomic recurrence determined by cystoscopy
Anatomic evidence of recurrence based on surveillance cystoscopy (i.e., if the 16F flexible cystoscope cannot bypass the surgical site then there is a failure). Flexible cystoscopy will be performed at 3 and 12 months after surgery. All surgeons will use a standard-sized scope. This will be a bivariate outcome (scope is able to pass without trauma vs. unable to pass or only able to pass with trauma)
Measured: 1 year
Secondary outcomes (1)
Cumulative Incidence of Complications deep venous incision and drainage
A composite outcome of the following rare peri-operative complications: deep venous thrombosis, positioning complaints (numbness in the feet), perineal abscess (requiring incision and drainage) and leakage of dye from the urethra on post-op voiding cystourethrogram. Each of these complications is expected to occur in about 1% of subjects. Therefore no standardized assessment will be performed: we will not perform screening ultrasound for DVT, nor will we give every patient a standardized questionnaire to assess for foot numbness. Rather, at each clinical visit, the physician will note whether the findings are present or absent based on physical exam, subjective complaints or objective tests.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Kansas, Ohio State University, University of Utah, Loyola University Chicago, Lahey Clinic, University of California, San Francisco, University of Washington, New York University, University of California, San Diego, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551783
- Sponsor's protocol ID
- 1508M77183
- Acronym
- DoVeBuG
- Status last verified
- Oct 2019
- First submitted
- 12 Aug 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 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
- NCT02551783
- Acronym / sponsor ID
- DoVeBuG / 1508M77183
- Conditions
- Urethral Stricture
- Keywords
- urethral stricture, urethroplasty, buccal mucosa, graft
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Iowa, University of Kansas, Ohio State University, University of Utah, Loyola University Chicago, Lahey Clinic, University of California, San Francisco, University of Washington, New York University, University of California, San Diego, Baylor College of Medicine
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 16 Sep 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.
This is 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 the 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
Urethral strictures affect 1% of men and are rare in women. Most urethral strictures in the United States develop in the bulbar section of the urethra which is the section of the urethra proximal to the penis but distal to the prostate. A common method of surgical correction is to longitudinally open the strictured urethra and augment its width by the addition of a graft of buccal mucosa taken from the oral cavity. The urethrotomy for placement of the graft can be made along the superficial (ventral) or deep (dorsal) side of the urethra. The graft bed dorsally is the tunica albuginea of the corporal bodies (the capsule around the erectile bodies of the penis) whereas ventrally it is the corpus spongiosum of the urethra (the vascular layer that surrounds the urethra).
Ventral buccal graft onlay first described by Morey and McAninch in 1996, involves a midline perineal incision and retraction of the bulbo-spongiosum 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 associated complications such as post-void dribbling and ejaculatory dysfunction. In addition, many surgeons have concern about graft contraction as spread-fixating the graft is not possible.
Dorsal buccal graft onlay, first described by Barbagli in 1996, 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 right mucosal margin of the urethra is sutured to the right margin of the buccal graft and 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 potentially allows for a more stable vascular bed for graft sustainability and less spongiosal bleeding, but requires a greater urethral mobilization and longer operative times. The technical challenge of graft placement in a dorsal location is much greater than placement ventrally. Potential problems with dorsal placement include damage to the male external urinary sphincter, which is dorsally located, and anastomotic leakage and perineal abscess in the immediate post-operative period.
There are multiple studies that attempt to compare the outcomes of ventral versus dorsal graft placement for bulbar urethroplasty, but these studies rely on case series and retrospective data. Andrich and Mundy reported better outcomes with dorsal buccal placement, but statistical significance was not formally established. Both Barbagli and Figler were unable to demonstrate superiority of either ventral or dorsal buccal graft placement. Currently there is no high level of definitive randomized evidence to suggest superiority of either ventral or dorsal buccal placement in terms of patient outcomes and complications. In fact, the best level of evidence is VI (small case series) and dorsal vs. ventral placement is largely dependent on individual clinical judgment and comfort level with each procedure.
One factor contributing to the inability to detect a difference between dorsal vs. ventral graft placement has been the liberal definition of success that leads to uniformly high success rates across studies (85-95%) and, hence, studies that are underpowered to detect a difference in success rates. In these studies, the definition of success has typically been "need for repeat surgery". Such a definition suffers from significant detection bias in that (1) subclinical stricture recurrences may go undetected if they are not screened for; and (2) surgeon or patient reluctance to undergo a repeat surgery may lead to false negatives. When patients are rigorously followed with endoscopic inspection of the area of surgery with cystoscopy, narrowing is often identified at a much higher rate than "need for repeat surgery". For instance, in a preliminary review of our retrospective data using surveillance cystoscopy, the investigators detected narrowing in 46% of ventral buccal patients and approximately 18% of dorsal buccal patients. This more strict definition of success and the lower success rates that follow may allow for detection of a clinically meaningful difference in the success rate with the two procedures in a reasonably-sized clinical trial.
The investigators plan a randomized comparison of dorsally-placed vs. ventrally-placed buccal mucosa graft in men undergoing buccal graft urethroplasty for bulbar urethra stricture. A collaborative multi-institutional study deriving data from the Trauma and Urologic Reconstruction Network of Surgeons, a network of twelve reconstructive urology centers in the United States, would allow the investigators to achieve the required sample size within 2-3 years. The results of this study will ultimately advance research efforts in urethral stricture management and provide substantial evidence for utilization of ventral versus dorsal buccal placement for reconstructive urologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urethroplasty with buccal mucosa graft | Experimental | Procedure: Urethroplasty with buccal mucosa graftIntervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the dorsal wall of the urethra. |
| Ventral Buccal | Active comparator | Procedure: Ventral BuccalIntervention: Procedure/Surgery: Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Strictures must predominantly include the proximal and/or mid bulbar urethra and be otherwise amenable to buccal graft onlay urethroplasty
- Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra within the scrotum, but not through the scrotum to the pendulous junction
- Subjects able to consent for themselves
Key exclusion criteria (4 listed)
- prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter placement, male urethral sling placement, and rectourethral fistula
- radiation therapy to the pelvis
- previous hypospadias repair
- lichen sclerosis unable to consent for themselves
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 |
|---|---|---|
| Urethroplasty with buccal mucosa graftA surgery to correct urethral stricture | Procedure or surgery | Urethroplasty with buccal mucosa graft |
| Ventral BuccalUrethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra. | Procedure or surgery | Ventral Buccal |
Primary outcome
Cumulative Incidence of anatomic recurrence determined by cystoscopy
Time frame: 1 year
Anatomic evidence of recurrence based on surveillance cystoscopy (i.e., if the 16F flexible cystoscope cannot bypass the surgical site then there is a failure). Flexible cystoscopy will be performed at 3 and 12 months after surgery. All surgeons will use a standard-sized scope. This will be a bivariate outcome (scope is able to pass without trauma vs. unable to pass or only able to pass with trauma)
1 secondary outcome
Cumulative Incidence of Complications deep venous incision and drainage
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethroplasty with buccal mucosa graft and Ventral Buccal in people with Urethral Stricture, run by University of Minnesota 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 3 inclusion and 4 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 1 Nov 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: Failure to recruit). 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?
Cumulative Incidence of anatomic recurrence determined by cystoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.