Vessel-sparing Technique Versus Conventional Repair of PFUI: A Prospective Comparative Study
Vessel-sparing Technique Versus Conventional Repair of Pelvic Fracture Urethral Injury: A Prospective Comparative Study
Pelvic fracture is associated with urethral injury in about 10% of patients . The common site of injury is at the bulbomembranous Junction and anastomotic urethroplasty with a tension free anastomosis remains the gold standard management for pelvic fracture urethral injury (PFUI) .
Traditional reconstruction of PFUI requires mobilization of the bulbar urethra to reach the prostatic apex with deep dissection of the spongiosum and detachment of the bulb from the perineal membrane at the site of the bulbomembranous urethral injury, a maneuver that requires division of the bulbar arteries . Then, the distal bulb and bulbar urethra will depend on retrograde blood flow through the glans and some perforating branches of the dorsal penile artery and this is usually sufficient to maintain good vitality of the spongiosum and urethra under normal circumstances .
When the distal blood supply to the urethra is compromised, either by congenital anomalies such a hypospadias, by previous surgery, or by the pre-existing pelvic fracture, the retrograde flow to the spongiosum is insufficient . In such cases, traditional anastomotic urethroplasty may result in ischemic bulbar necrosis, leading to a reconstructive failure and these patients usually fail to void soon after removal of the catheter, with subsequent retrograde urethrogram (RUG) showing a long bulbar urethral defect .
In 2007, Jordan et al described a modification to excision and primary anastomosis (EPA) in the proximal bulbar urethral strictures particularly post radical prostatectomy, which includes mobilizing and preserving the bulbar arteries with the continuity of the corpus spongiosum is maintained .
Gomez et al believed that vessel-sparing anastomotic urethroplasty is highly relevant in the PFUI scenario as it can theoretically help to avoid ischemic failure and cold glans syndrome improving sexual arousal. Consequently, they modified the standard reconstructive technique for PFUI by preserving bulbar arterial inflow .
So that, we decide to compare between vessel-sparing technique and conventional repair in management of PFUI through a prospective study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mena H Mahdy
- Phone Number: 01008413768
- Email: menaahosam1995@gmail.com
Study Locations
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Assiut, Egypt
- Assiut University
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Contact:
- Mohamed O Ali, MD
- Phone Number: 01112274899
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult male patients ≥ 18 years old with PFUI
Exclusion Criteria:
- Recurrent cases. • History of concomitant bladder neck injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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conventional repair
the patients will undergo repair with no regard to the vessels .then
follow up by uroflow ,ascending urethrogram and penile doppler .
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4. When the bulb and bulbar urethra are exposed and before further dissection, the bulbar arteries are located using a directional doppler ultrasound stethoscope and a decision is made to sacrifice the artery with the lowest doppler signal to preserve the contralateral best artery.
The bulbar urethra is then mobilized, circumferentially dissected and separated distally from the corpus cavernosum up to the penoscrotal angle to gain sufficient length for a tension-free end-to-end anastomosis without detachment of the bulb from the perineal body.
If the dissection is not sufficient to bridge the gap,inter-corporal septal separation or even an inferior pubectomy are performed.
The scarred tissue is removed completely, the proximal urethral segment is exposed as usual with spatulation of the healthy urethral ends and end-to-end anastomosis of the urethra over a silicon catheter is performed.
No dissection is performed contralaterally at the bulb to preserve the artery of that side.
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the new technique
the patients will undergo repair with sparing of the vessels .then
follow up by uroflow ,ascending urethrogram and penile doppler .
|
4. When the bulb and bulbar urethra are exposed and before further dissection, the bulbar arteries are located using a directional doppler ultrasound stethoscope and a decision is made to sacrifice the artery with the lowest doppler signal to preserve the contralateral best artery.
The bulbar urethra is then mobilized, circumferentially dissected and separated distally from the corpus cavernosum up to the penoscrotal angle to gain sufficient length for a tension-free end-to-end anastomosis without detachment of the bulb from the perineal body.
If the dissection is not sufficient to bridge the gap,inter-corporal septal separation or even an inferior pubectomy are performed.
The scarred tissue is removed completely, the proximal urethral segment is exposed as usual with spatulation of the healthy urethral ends and end-to-end anastomosis of the urethra over a silicon catheter is performed.
No dissection is performed contralaterally at the bulb to preserve the artery of that side.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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UROFLOWMETERY
Time Frame: three months after the operation
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the speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec
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three months after the operation
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postmicturition residue
Time Frame: three months after the operation
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abdominal ultrasound done to evaluate PMR
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three months after the operation
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Retrograde Urethrogram RUG
Time Frame: three months after the operation
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contrast study to evaluate and delineate the urethera
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three months after the operation
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gur U, Jordan GH. Vessel-sparing excision and primary anastomosis (for proximal bulbar urethral strictures). BJU Int. 2008 May;101(9):1183-95. doi: 10.1111/j.1464-410X.2008.07619.x. No abstract available.
- Durrant JJ, Ramasamy A, Salmon MS, Watkin N, Sargeant I. Pelvic fracture-related urethral and bladder injury. J R Army Med Corps. 2013 Mar;159 Suppl 1:i32-9. doi: 10.1136/jramc-2013-000025.
- Webster GD, Ramon J. Repair of pelvic fracture posterior urethral defects using an elaborated perineal approach: experience with 74 cases. J Urol. 1991 Apr;145(4):744-8. doi: 10.1016/s0022-5347(17)38442-2.
- Kulkarni SB, Surana S, Desai DJ, Orabi H, Iyer S, Kulkarni J, Dumawat A, Joshi PM. Management of complex and redo cases of pelvic fracture urethral injuries. Asian J Urol. 2018 Apr;5(2):107-117. doi: 10.1016/j.ajur.2018.02.005. Epub 2018 Mar 2.
- Gomez RG, Campos RA, Velarde LG. Reconstruction of Pelvic Fracture Urethral Injuries With Sparing of the Bulbar Arteries. Urology. 2016 Feb;88:207-12. doi: 10.1016/j.urology.2015.09.032. Epub 2015 Nov 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- new urethroplasty technique
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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