Penile SkinNCT07074717
Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture
A study testing Buccal Mucosal Graft (BMG) Urethroplasty and Penile Skin Graft (PSG) Urethroplasty in people with Penile Skin and Buccal Mucosal Graft, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture. Read more about this study
- Who is it for?
- Ages 18 months and older, men only
- Conditions the study is for
- Penile Skin, Buccal Mucosal Graft, Augmentation
- What is being tested?
- Buccal Mucosal Graft (BMG) Urethroplasty and Penile Skin Graft (PSG) Urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Dec 2025
- 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 18 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.
- Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)
Who cannot join
- Patients with lichen sclerosus
- Patients with history of hypospadias repair
- Patients with recurrent urethral stricture after failed previous urethroplasty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia Governorate, Egypt, 31527
Mohamed I Elmaadawy, MD, 00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg
About this study
Official title: Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture: A Prospective Randomized Study
The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.
Read the detailed description
Penile urethral reconstruction proves to be a continuous challenge as no perfect technique is considered for all patients with this problem. Among all the methods used for treatment of urethral stricture, the substitution urethroplasty with tissue transfer using either flap or graft is the gold standard treatment option for long segment urethral strictures.
In 1993, McAninch described a circular fasciocutaneous flap for the management of penile urethral stricture up to 15 cm that showed excellent cosmetic and functional outcomes due to this being a hairless, flexible flap with a rich vascular supply.
Buccal mucosal graft (BMG) was rediscovered and popularized in 1992 by Burger et al., then El-Kassaby et al. in 1993 published a series using buccal mucosal graft to repair anterior urethral stricture. Buccal mucosal graft became an ideal urethral substitute due to easy harvesting, hairlessness and compatibility in a wet environment.
- Conditions
- Penile Skin, Buccal Mucosal Graft, Augmentation, Urethroplasty, Long Anterior, Urethral Stricture
- Being tested
- Buccal Mucosal Graft (BMG) Urethroplasty, Penile Skin Graft (PSG) Urethroplasty
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Mucosal Graft (BMG) UrethroplastyProcedure or surgery
Also called Dorsal onlay buccal mucosal graft
Urethroplasty using a buccal mucosal graft harvested from the inner cheek. The graft is dorsally onlaid to reconstruct the strictured urethral segment. The procedure is conducted under spinal or general anesthesia.
Penile Skin Graft (PSG) UrethroplastyProcedure or surgery
Also called Dorsal onlay penile skin graft
Urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The graft is applied dorsally after excision of the fibrotic urethral segment. The surgery is performed under spinal or general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Buccal Mucosal Graft (BMG) | Experimental | Participants will undergo dorsal onlay augmentation urethroplasty using a buccal mucosal graft harvested from the inner cheek. The procedure is performed under spinal or general anesthesia. Graft is sutured dorsally over the strictured urethral segment after excision of the fibrotic tissue. Receives: Procedure: Buccal Mucosal Graft (BMG) Urethroplasty |
| Penile Skin Graft (PSG) | Experimental | Participants will undergo dorsal onlay augmentation urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The hairless skin is prepared and sutured dorsally over the strictured urethral segment. The procedure is done under spinal or general anesthesia. Receives: Procedure: Penile Skin Graft (PSG) Urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success Rate
Success is defined as satisfactory urinary stream with no need for further intervention (such as dilatation or DVIU) and no evidence of stricture on retrograde urethrogram during follow-up.
Measured: 9 months postoperatively
Secondary outcomes (3)
International Prostate Symptom Score (IPSS)
Evaluation of changes in urinary symptoms using International Prostate Symptom Score (IPSS) to assess functional outcome and patient comfort after urethroplasty will be assessed.
Measured: 9 months postoperatively
Length of Urethral Stricture
Length of Urethral Stricture will be measured to compare the characteristics of strictures managed by each graft technique.
Measured: Intraoperatively
Postoperative Complications
Complications such as infection, bleeding, graft failure, and fistula formation following surgery will be recorded.
Measured: 9 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile SkinStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074717
- Sponsor's protocol ID
- 36264PR1074/1/25
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07074717
- Acronym / sponsor ID
- 36264PR1074/1/25
- Conditions
- Penile Skin, Buccal Mucosal Graft, Augmentation, Urethroplasty, Long Anterior, Urethral Stricture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Jul 2025 (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.
The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.
Detailed description
Penile urethral reconstruction proves to be a continuous challenge as no perfect technique is considered for all patients with this problem. Among all the methods used for treatment of urethral stricture, the substitution urethroplasty with tissue transfer using either flap or graft is the gold standard treatment option for long segment urethral strictures.
In 1993, McAninch described a circular fasciocutaneous flap for the management of penile urethral stricture up to 15 cm that showed excellent cosmetic and functional outcomes due to this being a hairless, flexible flap with a rich vascular supply.
Buccal mucosal graft (BMG) was rediscovered and popularized in 1992 by Burger et al., then El-Kassaby et al. in 1993 published a series using buccal mucosal graft to repair anterior urethral stricture. Buccal mucosal graft became an ideal urethral substitute due to easy harvesting, hairlessness and compatibility in a wet environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal Mucosal Graft (BMG) | Experimental | Procedure: Buccal Mucosal Graft (BMG) UrethroplastyParticipants will undergo dorsal onlay augmentation urethroplasty using a buccal mucosal graft harvested from the inner cheek. The procedure is performed under spinal or general anesthesia. Graft is sutured dorsally over the strictured urethral segment after excision of the fibrotic tissue. |
| Penile Skin Graft (PSG) | Experimental | Procedure: Penile Skin Graft (PSG) UrethroplastyParticipants will undergo dorsal onlay augmentation urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The hairless skin is prepared and sutured dorsally over the strictured urethral segment. The procedure is done under spinal or general anesthesia. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.
- Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)
Key exclusion criteria (3 listed)
- Patients with lichen sclerosus
- Patients with history of hypospadias repair
- Patients with recurrent urethral stricture after failed previous urethroplasty
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 |
|---|---|---|
| Buccal Mucosal Graft (BMG) UrethroplastyAlso: Dorsal onlay buccal mucosal graftUrethroplasty using a buccal mucosal graft harvested from the inner cheek. The graft is dorsally onlaid to reconstruct the strictured urethral segment. The procedure is conducted under spinal or general anesthesia. | Procedure or surgery | Buccal Mucosal Graft (BMG) |
| Penile Skin Graft (PSG) UrethroplastyAlso: Dorsal onlay penile skin graftUrethroplasty using a penile skin graft harvested from the ventral surface of the penis. The graft is applied dorsally after excision of the fibrotic urethral segment. The surgery is performed under spinal or general anesthesia. | Procedure or surgery | Penile Skin Graft (PSG) |
Primary outcome
Surgical Success Rate
Time frame: 9 months postoperatively
Success is defined as satisfactory urinary stream with no need for further intervention (such as dilatation or DVIU) and no evidence of stricture on retrograde urethrogram during follow-up.
3 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: 9 months postoperatively
Length of Urethral Stricture
Time frame: Intraoperatively
Postoperative Complications
Time frame: 9 months postoperatively
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal Mucosal Graft (BMG) Urethroplasty and Penile Skin Graft (PSG) Urethroplasty in people with Penile Skin and Buccal Mucosal Graft, run by Tanta 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. 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?
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?
Contact Mohamed I Elmaadawy, MD (00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Success Rate (time frame: 9 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.