Traumatic Urethral Stricture, Male, Overlapping SitesNCT06248047
Vessel-sparing Technique Versus Conventional Repair of PFUI: A Prospective Comparative Study
An observational study of Traumatic Urethral Stricture, Male, Overlapping Sites, run by Assiut University at 1 site in Egypt.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Traumatic Urethral Stricture, Male, Overlapping Sites
- What is being tested?
- uretheroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2024to 31 Jan 2026
- Phase
- Observational
- 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 80 years
- Men only
- Adult, Older adult
Study population: patient with pelvis fracture type A , B and C , cystocathater .
Who may be able to join
- Adult male patients ≥ 18 years old with PFUI
Who cannot join
- Recurrent cases. • History of concomitant bladder neck injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read more
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.
- Being tested
- uretheroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uretheroplastyProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| conventional repair | the patients will undergo repair with no regard to the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler . Receives: Procedure: uretheroplasty | |
| the new technique | the patients will undergo repair with sparing of the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler . Receives: Procedure: uretheroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
UROFLOWMETERY
the speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec
Measured: three months after the operation
postmicturition residue
abdominal ultrasound done to evaluate PMR
Measured: three months after the operation
Retrograde Urethrogram RUG
contrast study to evaluate and delineate the urethera
Measured: three months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start31 Jan 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Urethral Stricture, Male, Overlapping SitesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Hosam Mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248047
- Sponsor's protocol ID
- new urethroplasty technique
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23631324Webster 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.
PubMed 2005693Kulkarni 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.
PubMed 29736373Gomez 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.
PubMed 26616094Gur 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.
PubMed 18399836
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel-sparing Technique Versus Conventional Repair of Pelvic Fracture Urethral Injury: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06248047
- Acronym / sponsor ID
- new urethroplasty technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional repair | – | Procedure: uretheroplastythe patients will undergo repair with no regard to the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler . |
| the new technique | – | Procedure: uretheroplastythe patients will undergo repair with sparing of the vessels .then follow up by uroflow ,ascending urethrogram and penile doppler . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- patient with pelvis fracture type A , B and C , cystocathater .
Key inclusion criteria (1 listed)
- Adult male patients ≥ 18 years old with PFUI
Key exclusion criteria (1 listed)
- Recurrent cases. • History of concomitant bladder neck injury
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 |
|---|---|---|
| uretheroplasty4. 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. | Procedure or surgery | conventional repair, the new technique |
Primary outcome
UROFLOWMETERY
Time frame: three months after the operation
the speed and feasibility of micturition measured by non invasive pressure flow study Q max more than 10ml/sec
postmicturition residue
Time frame: three months after the operation
abdominal ultrasound done to evaluate PMR
Retrograde Urethrogram RUG
Time frame: three months after the operation
contrast study to evaluate and delineate the urethera
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 23631324Durrant 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.
- Background: PubMed 2005693Webster 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.
- Background: PubMed 29736373Kulkarni 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.
- Background: PubMed 26616094Gomez 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.
- Background: PubMed 18399836Gur 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.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Urethral Stricture, Male, Overlapping Sites, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mena H Mahdy (01008413768, menaahosam1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UROFLOWMETERY (time frame: three months after the operation). The study lists 3 primary outcomes in all. 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 NCT06248047, which also lists 5 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 8 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.