Urethral Stricture, AnteriorBMGNCT07436819
Outcomes of Double-face Augmentation Urethroplasty
A study testing Double-face augmentation urethroplasty in people with Urethral Stricture, Anterior and Urethral Stricture Disease, run by Menoufia University at 2 sites in Egypt.
Trial summary
Combined dorsal and ventral onlay augmentation for bul¬bar urethral reconstruction. Nontraumatic near-obliterative bulbar urethral strictures (BUS) of <2 cm in length can be managed with non-transecting anastomotic bulbar urethroplasty or augmented anastomotic urethroplasty. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urethral Stricture, Anterior, Urethral Stricture Disease
- What is being tested?
- Double-face augmentation urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will include patients with long segment bulbar urethral stricture (>2 cm).Urethral lumen size less than 6 Fr.
Who cannot join
- Urethro-cutaneous fistula, urethral abscess or diverticulum. A scarred and unsalvageable urethral plate or scarred perineum. Lichen sclerosis (Balanitis xerotica obliterans). Unhealthy/unavailable buccal mucosa.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Menoufia faculty of medicine
Shibīn al Kawm, Al-Minoufiya, 52314
Menoufia faculty of medicine
Shibīn al Kawm, Al-Minufia, 52314
About this study
Official title: Outcomes of Double-face Augmentation Urethroplasty Using Buccal Mucosal Graft in Near-obliterative Bulbar Urethral Stricture
Combined dorsal and ventral onlay augmentation for bul¬bar urethral reconstruction.
Nontraumatic near-obliterative bulbar urethral strictures (BUS) of <2 cm in length can be managed with non-transecting anastomotic bulbar urethroplasty or augmented anastomotic urethroplasty. However, if the obliterative stricture segment is >2 cm and the urethral caliber is <6F, augmentation with a single graft may not be sufficient. We present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique.
Read the detailed description
Combined dorsal and ventral onlay augmentation urethroplasty technique was for bulbar urethral reconstruction.
Nontraumatic near-obliterative bulbar urethral strictures (BUS) of <2 cm in length can be managed with non-transecting anastomotic bulbar urethroplasty or augmented anastomotic urethroplasty. However, if the obliterative stricture segment is >2 cm and the urethral caliber is <6F, augmentation with a single graft may not be sufficient. In these cases, double-face augmentation urethroplasty (DFAU) is indicated. DFAU can be performed using either a dorsal (dorsal onlay and ventral inlay) or ventral (ventral onlay and dorsal inlay) approach.
In dorsal approach, the urethra was mobilized on the left side. Dorsal urethrotomy was performed at the level of the stricture. A free graft was harvested and fixed to the apex of the proximal urethral margin using interrupted sutures (sutured to the medial urethral margin and the underlying corpora cavernosa). Ventral inlay augmentation with a free graft was at the level of the narrowed urethral plate (<6 mm) and the urethra was closed over a 16F catheter.
Aim of the study Investigator present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique.
Study type: a prospective non-controlled interventional study. Sampling: hospital-based sample. Masking: open label. Intervention Model: all participants with long segment more than 2 cm near-obliterative bulbar urethral stricture underwent the double-face augmentation urethroplasty technique through one-sided dorsal perineal approach.
Sample size: all participants for the next 2 years. Study Location: El-Hussein, Sayed Galal, Al-Azhar University Hospitals, Cairo, and Menoufia university hospital, Cairo, Egypt.
Study Population Inclusion criteria The study will include participants with long segment bulbar urethral stricture (>2 cm).
Urethral lumen size less than 6 Fr. Exclusion criteria Urethro-cutaneous fistula, urethral abscess or diverticulum. A scarred and unsalvageable urethral plate or scarred perineum. Lichen sclerosis (Balanitis xerotica obliterans). Unhealthy/unavailable buccal mucosa.
Pre-operative evaluation:
Medical and surgical history including age, cause of stricture, presence of medical diseases like diabetes mellitus, and history of previous urethral procedures.
The following questionnaires will be used for assessment of LUTS, sexual function and satisfaction, and oral health:
IPSS (international prostate symptom score). IIEF-5 Score (international index of erectile function). MSHQEJD (male sexual health and ejaculatory dysfunction questionnaire). BMG questionnaire for brief oral health status examination (BOHSE).
Physical examination including BMI, oral, abdominal and penile examination and presence of supra-pubic catheter.
Laboratory investigations (urine analysis, urine culture and sensitivity, complete blood count, bleeding profile and serum creatinine levels).
Uroflowmetry (UFM).
Radiologic investigations:
Retrograde urethrography (RGU) and micturating cystourethrography (MCU). Renal and bladder ultrasound with estimation of pre and post voiding residual urine.
An informed consent will be signed by each patient. surgical technique: The participant will be put in lithotomy position then a midline perineal incision will be made \& buccal mucosal graft will be harvested.
Buccal graft harvest Using a marking pen, the graft well be outlined 2.5 cm wide and as long as is required. Bupivacaine 0.5% with epinephrine will be injected underneath the graft for good analgesia and intraoperative hemostasis. The graft will be then incised and dissected of the buccinator muscle, while avoiding Stensen's duct. The defect will be left open to close by secondary intention, as it is less painful. The graft will be pinned out and defatted/thinned on the back table. It will be kept in saline until the time of implantation.
The patient is placed in an exaggerated lithotomy position. A 16Fr urinary catheter is inserted, identifying the distal end of the segment affected by stenosis, and methylene blue is injected. A longitudinal incision is made in the perineum. The left and dorsal surfaces of the urethra are dissected, with the right border maintained. A longitudinal incision is made along the midline of the dorsal wall of the urethra affected by stenosis, extending up to 1cm beyond the area of stenosis, preserving the spongy tissue. The defect created in the urethra acquires an elliptical form and the oral mucosa will be placed as an inlay graft onto this segment. The incision in the urethra should proceed until the maximum degree of relaxation is achieved, preserving the corpus spongiosum. The graft is secured to the corpus spongiosum, as is usual with these grafts, using separate oral mucosa/corpus spongiosum sutures with 4-0 vicryl. Next, the edge of the graft is fixed to the edge of the urethra using continuous sutures with 5-0 vicryl. The remaining portion of oral mucosa is fixed onto the corpus cavernosum. The edges of the urethra are then sutured to the dorsal oral mucosa using 4-0 vicryl suture. A schematic drawing is provided to further illustrate the placement of the mucosal grafts.
FOLLOW UP: The follow up period will be at least 6 months The participants will be treated with broad spectrum IV antibiotics for 48-72 h, which will be followed by oral antibiotics until catheter removal. The participants will be also treated with analgesics, bladder antispasmodics, stool softener, and diazepam to help prevent erections.
The participants will be discharged after the drain is removed, if it was put, usually within 2-3 days after surgery.
Participants will be followed up at the clinic after 1 week for wound assessment. Another visit will be scheduled 30 days after surgery where the urethral catheter will be removed, and a voiding urethrogram will be taken.
A 3 monthly follow-up visits thereafter will be scheduled for assessment of LUTS with performing simple uroflowmetry, treatment satisfaction and sexual function.
The follow-up will rely mainly on patient symptoms (subjective diminished force-of-stream, UTI, urinary retention, etc.), while diagnostic procedures such as urethroscopy and/or retrograde urethrogram will be done selectively.
OUTCOME Anatomic (Objective): Urethral patency will be evaluated by Uroflowmetry, and Urethrography.
Functional (Subjective): LUTS, sexual function, and satisfaction. Through:
IPSS (international prostate symptom score). IIEF-5 Score (international index of erectile function). MSHQEJD (male sexual health and ejaculatory dysfunction questionnaire). USS-PROM (patient reported outcome for urethral stricture surgery).
- Being tested
- Double-face augmentation urethroplasty
- Keywords
- double-face urethroplasty, buccal mucosal 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.
Double-face augmentation urethroplastyProcedure or surgery
We present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique.
| Study group | Role | What they receive |
|---|---|---|
| bulbar urethral stricture disease | Experimental | We present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique. Receives: Procedure: Double-face augmentation urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral patency
Urethral patency will be evaluated by Uroflowmetry, and Urethrography
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethral Stricture, AnteriorStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali abdelghaffar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436819
- Sponsor's protocol ID
- Urol1/2025
- Acronym
- BMG
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ballesteros Ruiz C, Bandini M, Joshi PM, Bafna S, Sharma V, Yatam SL, Bhadranavar S, Patil A, Kulkarni SB. Dorsal approach for double-face bulbar urethroplasty: ventral inlay plus dorsal onlay using Kulkarni one-side dissection. Int Urol Nephrol. 2022 May;54(5):1039-1045. doi: 10.1007/s11255-022-03158-9. Epub 2022 Mar 6.
PubMed 35249203
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Double-face Augmentation Urethroplasty Using Buccal Mucosal Graft in Near-obliterative Bulbar Urethral Stricture
- ClinicalTrials.gov ID
- NCT07436819
- Acronym / sponsor ID
- BMG / Urol1/2025
- Keywords
- double-face urethroplasty, buccal mucosal graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
Combined dorsal and ventral onlay augmentation for bul¬bar urethral reconstruction.
Nontraumatic near-obliterative bulbar urethral strictures (BUS) of <2 cm in length can be managed with non-transecting anastomotic bulbar urethroplasty or augmented anastomotic urethroplasty. However, if the obliterative stricture segment is >2 cm and the urethral caliber is <6F, augmentation with a single graft may not be sufficient. We present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique.
Detailed description
Combined dorsal and ventral onlay augmentation urethroplasty technique was for bulbar urethral reconstruction.
Nontraumatic near-obliterative bulbar urethral strictures (BUS) of <2 cm in length can be managed with non-transecting anastomotic bulbar urethroplasty or augmented anastomotic urethroplasty. However, if the obliterative stricture segment is >2 cm and the urethral caliber is <6F, augmentation with a single graft may not be sufficient. In these cases, double-face augmentation urethroplasty (DFAU) is indicated. DFAU can be performed using either a dorsal (dorsal onlay and ventral inlay) or ventral (ventral onlay and dorsal inlay) approach.
In dorsal approach, the urethra was mobilized on the left side. Dorsal urethrotomy was performed at the level of the stricture. A free graft was harvested and fixed to the apex of the proximal urethral margin using interrupted sutures (sutured to the medial urethral margin and the underlying corpora cavernosa). Ventral inlay augmentation with a free graft was at the level of the narrowed urethral plate (<6 mm) and the urethra was closed over a 16F catheter.
Aim of the study Investigator present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique.
Study type: a prospective non-controlled interventional study. Sampling: hospital-based sample. Masking: open label. Intervention Model: all participants with long segment more than 2 cm near-obliterative bulbar urethral stricture underwent the double-face augmentation urethroplasty technique through one-sided dorsal perineal approach.
Sample size: all participants for the next 2 years. Study Location: El-Hussein, Sayed Galal, Al-Azhar University Hospitals, Cairo, and Menoufia university hospital, Cairo, Egypt.
Study Population Inclusion criteria The study will include participants with long segment bulbar urethral stricture (>2 cm).
Urethral lumen size less than 6 Fr. Exclusion criteria Urethro-cutaneous fistula, urethral abscess or diverticulum. A scarred and unsalvageable urethral plate or scarred perineum. Lichen sclerosis (Balanitis xerotica obliterans). Unhealthy/unavailable buccal mucosa.
Pre-operative evaluation:
Medical and surgical history including age, cause of stricture, presence of medical diseases like diabetes mellitus, and history of previous urethral procedures.
The following questionnaires will be used for assessment of LUTS, sexual function and satisfaction, and oral health:
IPSS (international prostate symptom score). IIEF-5 Score (international index of erectile function). MSHQEJD (male sexual health and ejaculatory dysfunction questionnaire). BMG questionnaire for brief oral health status examination (BOHSE).
Physical examination including BMI, oral, abdominal and penile examination and presence of supra-pubic catheter.
Laboratory investigations (urine analysis, urine culture and sensitivity, complete blood count, bleeding profile and serum creatinine levels).
Uroflowmetry (UFM).
Radiologic investigations:
Retrograde urethrography (RGU) and micturating cystourethrography (MCU). Renal and bladder ultrasound with estimation of pre and post voiding residual urine.
An informed consent will be signed by each patient. surgical technique: The participant will be put in lithotomy position then a midline perineal incision will be made \& buccal mucosal graft will be harvested.
Buccal graft harvest Using a marking pen, the graft well be outlined 2.5 cm wide and as long as is required. Bupivacaine 0.5% with epinephrine will be injected underneath the graft for good analgesia and intraoperative hemostasis. The graft will be then incised and dissected of the buccinator muscle, while avoiding Stensen's duct. The defect will be left open to close by secondary intention, as it is less painful. The graft will be pinned out and defatted/thinned on the back table. It will be kept in saline until the time of implantation.
The patient is placed in an exaggerated lithotomy position. A 16Fr urinary catheter is inserted, identifying the distal end of the segment affected by stenosis, and methylene blue is injected. A longitudinal incision is made in the perineum. The left and dorsal surfaces of the urethra are dissected, with the right border maintained. A longitudinal incision is made along the midline of the dorsal wall of the urethra affected by stenosis, extending up to 1cm beyond the area of stenosis, preserving the spongy tissue. The defect created in the urethra acquires an elliptical form and the oral mucosa will be placed as an inlay graft onto this segment. The incision in the urethra should proceed until the maximum degree of relaxation is achieved, preserving the corpus spongiosum. The graft is secured to the corpus spongiosum, as is usual with these grafts, using separate oral mucosa/corpus spongiosum sutures with 4-0 vicryl. Next, the edge of the graft is fixed to the edge of the urethra using continuous sutures with 5-0 vicryl. The remaining portion of oral mucosa is fixed onto the corpus cavernosum. The edges of the urethra are then sutured to the dorsal oral mucosa using 4-0 vicryl suture. A schematic drawing is provided to further illustrate the placement of the mucosal grafts.
FOLLOW UP: The follow up period will be at least 6 months The participants will be treated with broad spectrum IV antibiotics for 48-72 h, which will be followed by oral antibiotics until catheter removal. The participants will be also treated with analgesics, bladder antispasmodics, stool softener, and diazepam to help prevent erections.
The participants will be discharged after the drain is removed, if it was put, usually within 2-3 days after surgery.
Participants will be followed up at the clinic after 1 week for wound assessment. Another visit will be scheduled 30 days after surgery where the urethral catheter will be removed, and a voiding urethrogram will be taken.
A 3 monthly follow-up visits thereafter will be scheduled for assessment of LUTS with performing simple uroflowmetry, treatment satisfaction and sexual function.
The follow-up will rely mainly on patient symptoms (subjective diminished force-of-stream, UTI, urinary retention, etc.), while diagnostic procedures such as urethroscopy and/or retrograde urethrogram will be done selectively.
OUTCOME Anatomic (Objective): Urethral patency will be evaluated by Uroflowmetry, and Urethrography.
Functional (Subjective): LUTS, sexual function, and satisfaction. Through:
IPSS (international prostate symptom score). IIEF-5 Score (international index of erectile function). MSHQEJD (male sexual health and ejaculatory dysfunction questionnaire). USS-PROM (patient reported outcome for urethral stricture surgery).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bulbar urethral stricture disease | Experimental | Procedure: Double-face augmentation urethroplastyWe present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include patients with long segment bulbar urethral stricture (>2 cm).Urethral lumen size less than 6 Fr.
Key exclusion criteria (1 listed)
- Urethro-cutaneous fistula, urethral abscess or diverticulum. A scarred and unsalvageable urethral plate or scarred perineum. Lichen sclerosis (Balanitis xerotica obliterans). Unhealthy/unavailable buccal mucosa.
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 |
|---|---|---|
| Double-face augmentation urethroplastyWe present our initial experience with the double-face augmentation urethroplasty technique using buccal mucosal graft for near-obliterative bulbar urethral strictures through ventral or one-sided dorsal perineal approach and the analysis of the short-term outcomes of this technique. | Procedure or surgery | bulbar urethral stricture disease |
Primary outcome
Urethral patency
Time frame: at least 2 years
Urethral patency will be evaluated by Uroflowmetry, and Urethrography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 35249203Ballesteros Ruiz C, Bandini M, Joshi PM, Bafna S, Sharma V, Yatam SL, Bhadranavar S, Patil A, Kulkarni SB. Dorsal approach for double-face bulbar urethroplasty: ventral inlay plus dorsal onlay using Kulkarni one-side dissection. Int Urol Nephrol. 2022 May;54(5):1039-1045. doi: 10.1007/s11255-022-03158-9. Epub 2022 Mar 6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-face augmentation urethroplasty in people with Urethral Stricture, Anterior and Urethral Stricture Disease, run by Menoufia University at 2 sites 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Urethral patency (time frame: at least 2 years). 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 NCT07436819, which also lists 1 linked publication.
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 7 Oct 2026.