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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06248047
Enrollment
32
Registered
2024-02-08
Start date
2024-01-31
Completion date
2026-01-31
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Urethral Stricture, Male, Overlapping Sites

Brief summary

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.

Interventions

PROCEDUREuretheroplasty

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years

Inclusion criteria

\- Adult male patients ≥ 18 years old with PFUI

Exclusion criteria

* Recurrent cases. • History of concomitant bladder neck injury

Design outcomes

Primary

MeasureTime frameDescription
postmicturition residuethree months after the operationabdominal ultrasound done to evaluate PMR
UROFLOWMETERYthree months after the operationthe speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec
Retrograde Urethrogram RUGthree months after the operationcontrast study to evaluate and delineate the urethera

Countries

Egypt

Contacts

Primary ContactMena H Mahdy
menaahosam1995@gmail.com01008413768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026