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

Sponsor
University of California, San Francisco (Other)
Overall Status
Terminated
CT.gov ID
NCT02634619
Collaborator
University of Minnesota (Other), Baylor College of Medicine (Other), University of Iowa (Other), University of Kansas (Other), Central Ohio Urology Group (Other), Loyola University Chicago (Other), Lahey Clinic (Other), University of Washington (Other), New York University (Other), University of California, San Diego (Other), University of Utah (Other)
95
Enrollment
1
Location
2
Arms
29
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ventral buccal mucosa onlay urethroplasty
  • Procedure: Dorsal buccal mucosa onlay urethroplasty
 N/A

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):

  5. 2-4 weeks: urethral catheter removal and urethrogram to document well-healed suture line

  6. 3 and 12 months post-operative clinic visit:

  1. 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
  1. 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

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ventral Buccal Mucosa Graft Onlay

Standard of care method for repairing urethral strictures

Procedure: Ventral buccal mucosa onlay urethroplasty
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.
Active Comparator: Dorsal Buccal Mucosa Graft Onlay

Standard of care method for repairing urethral strictures

Procedure: Dorsal buccal mucosa onlay urethroplasty
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.

Outcome Measures

Primary Outcome Measures

  1. Anatomic recurrence of urethral stricture observed by cystoscopy or RUG/VCUG [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

Secondary Outcome Measures

  1. 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]

    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.

  2. Outcome of perioperative complication: positioning complaints [Through study completion, an average of up to 1 year]

    In order to do the operation, patients are placed in an exaggerated lithotomy position that may cause nerve injury or muscle soreness

  3. Outcome of perioperative complication perineal abscess, determined through physical or digital examination: [Through study completion, an average of up to 1 year]

    Perineal abscess is an infectious complication that develops after bacteria overgown and form a collection of pus. Often this will require surgical drainage

  4. 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]

    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.

  5. Max urinary flow rate (mL/sec) [Observed at 3 month post-op & 12 month post-op]

    Maximal milliliters per seconds that the patient can urinate

  6. Intervention rate: catheter self dilation / dilation [Through study completion, an average of up to 1 year]

    Patients will occasionally perform self dilation with a catheter to keep their stricture patent after surgery.

  7. Intervention rate: DVIU [Through study completion, an average of up to 1 year]

    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.

  8. Intervention rate: repeat urethroplasty [Through study completion, an average of up to 1 year]

    Stricture recurrence that causes severe restriction in urinary flow may require a repeat urethroplasty

Other Outcome Measures

  1. Delta Sexual Health Inventory for Men (SHIM) to determinate erectile dysfunction [Administered at 3 &12 month post op]

    This is a validated abridged and slightly modified 5-item version of the 15-item International Index of Erectile Function, designed for easy use, by clinicians, to diagnose the presence and severity of ED in clinical settings

  2. Delta Male Sexual Health Questionnaire (MSHQ) to assess sexual function [Administered at 3 & 12 month post op]

    This is a validated questionaire that includes domains for erectile function, ejaculatory function, sexual satisfaction, and provides a more in depth assessment of ejaculatory function and sexual satisfaction than the IIEF.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco
  • 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

Investigators

  • Principal Investigator: benjamin n breyer, MD, MAS, FAC, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Benjamin Breyer, MD, Chief of Urology, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02634619
Other Study ID Numbers:
  • K12DK083021-DvV
  • K12DK083021
First Posted:
Dec 18, 2015
Last Update Posted:
Apr 25, 2019
Last Verified:
Apr 1, 2019
Keywords provided by Benjamin Breyer, MD, Chief of Urology, University of California, San Francisco
urethral stricture
Additional relevant MeSH terms:
Urethral Stricture
Constriction, Pathologic

Study Results

No Results Posted as of Apr 25, 2019