Ureter StrictureEarly Phase 1NCT07797829
Buccal Mucosal Graft Ureteroplasty for Treatment of Proximal Ureteric Strictures, A Clinical Case Series.
A Early Phase 1 study testing Buccal mucosal graft ureteroplasty in people with Ureter Stricture, run by Mohamed Salah Abdul Mawgoud.
Trial summary
While short strictures and even long strictures in the distal or mid-section of the ureter can easily be repaired by end-to-end anastomosis or simple re-implantation as well as standard procedures, such as psoas bladder hitch and/or Boari-flap, reconstructions of long proximal ureter remain rare and challenging (1)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureter Stricture
- What is being tested?
- Buccal mucosal graft ureteroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Mar 2028
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years) of either sex.
- Confirmed diagnosis of long (>2 cm) upper and middle ureteric strictures, either fresh or recurrent with previous open or endoscopic intervention.
Who cannot join
- Malignant ureteric stricture or stricture secondary to active pelvic/retroperitoneal malignancy.
- Active urinary tract infection at the time of planned surgery.
- Uncorrected coagulopathy or other contraindication to anesthesia/surgery.
- Active oral mucosal disease, oral submucous fibrosis or previous bilateral grafting.
- Solitary non-functioning kidney on the affected side with differential renal function<15% on renogram (relative or absolute non-functioning renal unit) unless reconstruction is otherwise indicated.
- Pregnancy.
- Cases of ureteric avulsion where ileal ureter substitution will be used or cases with complete ureter obliteration no passing guidewire or ureteric catheter.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
While short strictures and even long strictures in the distal or mid-section of the ureter can easily be repaired by end-to-end anastomosis or simple re-implantation as well as standard procedures, such as psoas bladder hitch and/or Boari-flap, reconstructions of long proximal ureter remain rare and challenging (1), Although long segment proximal ureteric stricture (LPUS) have traditionally been managed with ileal ureter replacement (IUR) or renal auto transplantation (RA), these procedures may be technically difficult to perform and associated with considerable morbidity.(2) While buccal mucosa grafts (BMG) in urethral reconstruction are well established, only few small series for BMG in ureteric stricture have been reported. While showing promising results, these studies were flawed by inhomogeneous cohorts of patients with different kinds of strictures like uretero-pelvic junction (UPJ) obstruction, proximal and mid-ureter strictures that were treated with different techniques such as onlay ureteroplasty or augmented end-to-endanastomosis. Even though buccal mucosa harvesting is well established and straightforward current guidelines still do not recommend BMG ureteroplasty as an equal alternative to more invasive alternatives such as ileum interposition or renal auto-transplantation. (3) In 1999, Naude (4) introduced an alternative and innovative technique for treating ureteric strictures by utilizing buccal mucosa grafts (BMG) in conjunction with omental wrapping. Implementing onlay BMG during ureteral reconstruction eliminates the necessity for extensive ureterolysis, reducing disruption to the peri-ureteral blood supply. Furthermore, the BMG can be customized to accommodate the dimensions of the ureteral defect, ensuring a tension-free anastomosis. (5)
- Conditions
- Ureter Stricture
- Being tested
- Buccal mucosal graft ureteroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal mucosal graft ureteroplastyProcedure or surgery
Ureteric Exposure and Stricturoplasty The affected ureteric segment is approached (open flank) for upper third and Abernathy for middle ureteric stricture. and the stricture is identified and confirmed. The ureter is opened longitudinally (ureterotomy) with no. 11 blade across the full length of the stricture guided by the catheter onto 1 cm of healthy tissue proximally and distally. In short tight areas with maximal narrowing <1 cm, mucosa is excised and mucosa to mucosa anastomosis is done. The prepared BMG is fashioned onto the ureterotomy defect (onlay technique) or configured as an augmentation patch and secured with vicryl 5-0 continuous absorbable sutures over a silicon 6/26 Dj stent.
A double-J ureteric stent is placed across the repaired segment prior to completion of the graft inset to splint the reconstruction and ensure adequate drainage during graft take. Omental wrap or peri-ureteric fat/tissue coverage of the graft is performed where feasible to enhance graft vasculariza
| Study group | Role | What they receive |
|---|---|---|
| Patients with proximal ureteric strictures | Experimental | Not described Receives: Procedure: Buccal mucosal graft ureteroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success defined as ureteric patency without need for re-intervention
Measured: 1 year
Surgical success defined as ureteric patency without need for re- intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2028 (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 Ureter StrictureStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Salah Abdul Mawgoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Salah Abdul Mawgoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797829
- Sponsor's protocol ID
- 01011486957
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nasef AS, Tagrida IAE, Salman MF, Elatreisy A, Khaled SM. Buccal mucosal graft for onlay ureteroplasty in the management of proximal ureteral stricture. Single centre, prospective trial. Arch Ital Urol Androl. 2025 Jun 30;97(2):13695. doi: 10.4081/aiua.2025.13695. Epub 2025 May 15.
PubMed 40372200Naude JH. Buccal mucosal grafts in the treatment of ureteric lesions. BJU Int. 1999 May;83(7):751-4. doi: 10.1046/j.1464-410x.1999.00019.x.
PubMed 10368190Kocot A, Kalogirou C, Vergho D, Riedmiller H. Long-term results of ileal ureteric replacement: a 25-year single-centre experience. BJU Int. 2017 Aug;120(2):273-279. doi: 10.1111/bju.13825. Epub 2017 Mar 21.
PubMed 28220579Lee M, Lee Z, Koster H, Jun M, Asghar AM, Lee R, Strauss D, Patel N, Kim D, Komaravolu S, Drain A, Metro MJ, Zhao L, Stifelman M, Eun DD; Collaborative of Reconstructive Robotic Ureteral Surgery (CORRUS). Intermediate-term outcomes after robotic ureteral reconstruction for long-segment (>/=4 centimeters) strictures in the proximal ureter: A multi-institutional experience. Investig Clin Urol. 2021 Jan;62(1):65-71. doi: 10.4111/icu.20200298. Epub 2020 Nov 12.
PubMed 33258325Hefermehl LJ, Tritschler S, Kretschmer A, Beck V, Stief CG, Schlenker B, Strittmatter F. Open ureteroplasty with buccal mucosa graft for long proximal strictures: A good option for a rare problem. Investig Clin Urol. 2020 May;61(3):316-322. doi: 10.4111/icu.2020.61.3.316. Epub 2020 Mar 9.
PubMed 32377609
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Mucosal Graft Ureteroplasty for Treatment of Proximal Ureteric Strictures, A Clinical Case Series.
- ClinicalTrials.gov ID
- NCT07797829
- Acronym / sponsor ID
- 01011486957
- Conditions
- Ureter Stricture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mohamed Salah Abdul MawgoudUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 1 Sep 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.
While short strictures and even long strictures in the distal or mid-section of the ureter can easily be repaired by end-to-end anastomosis or simple re-implantation as well as standard procedures, such as psoas bladder hitch and/or Boari-flap, reconstructions of long proximal ureter remain rare and challenging (1), Although long segment proximal ureteric stricture (LPUS) have traditionally been managed with ileal ureter replacement (IUR) or renal auto transplantation (RA), these procedures may be technically difficult to perform and associated with considerable morbidity.(2) While buccal mucosa grafts (BMG) in urethral reconstruction are well established, only few small series for BMG in ureteric stricture have been reported. While showing promising results, these studies were flawed by inhomogeneous cohorts of patients with different kinds of strictures like uretero-pelvic junction (UPJ) obstruction, proximal and mid-ureter strictures that were treated with different techniques such as onlay ureteroplasty or augmented end-to-endanastomosis. Even though buccal mucosa harvesting is well established and straightforward current guidelines still do not recommend BMG ureteroplasty as an equal alternative to more invasive alternatives such as ileum interposition or renal auto-transplantation. (3) In 1999, Naude (4) introduced an alternative and innovative technique for treating ureteric strictures by utilizing buccal mucosa grafts (BMG) in conjunction with omental wrapping. Implementing onlay BMG during ureteral reconstruction eliminates the necessity for extensive ureterolysis, reducing disruption to the peri-ureteral blood supply. Furthermore, the BMG can be customized to accommodate the dimensions of the ureteral defect, ensuring a tension-free anastomosis. (5)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with proximal ureteric strictures | Experimental | Procedure: Buccal mucosal graft ureteroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years) of either sex.
- Confirmed diagnosis of long (>2 cm) upper and middle ureteric strictures, either fresh or recurrent with previous open or endoscopic intervention.
Key exclusion criteria (7 listed)
- Malignant ureteric stricture or stricture secondary to active pelvic/retroperitoneal malignancy.
- Active urinary tract infection at the time of planned surgery.
- Uncorrected coagulopathy or other contraindication to anesthesia/surgery.
- Active oral mucosal disease, oral submucous fibrosis or previous bilateral grafting.
- Solitary non-functioning kidney on the affected side with differential renal function<15% on renogram (relative or absolute non-functioning renal unit) unless reconstruction is otherwise indicated.
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 ureteroplastyUreteric Exposure and Stricturoplasty The affected ureteric segment is approached (open flank) for upper third and Abernathy for middle ureteric stricture. and the stricture is identified and confirmed. The ureter is opened longitudinally (ureterotomy) with no. 11 blade across the full length of the stricture guided by the catheter onto 1 cm of healthy tissue proximally and distally. In short tight areas with maximal narrowing <1 cm, mucosa is excised and mucosa to mucosa anastomosis is done. The prepared BMG is fashioned onto the ureterotomy defect (onlay technique) or configured as an augmentation patch and secured with vicryl 5-0 continuous absorbable sutures over a silicon 6/26 Dj stent. A double-J ureteric stent is placed across the repaired segment prior to completion of the graft inset to splint the reconstruction and ensure adequate drainage during graft take. Omental wrap or peri-ureteric fat/tissue coverage of the graft is performed where feasible to enhance graft vasculariza | Procedure or surgery | Patients with proximal ureteric strictures |
Primary outcome
Surgical success defined as ureteric patency without need for re-intervention
Time frame: 1 year
Surgical success defined as ureteric patency without need for re- intervention
Time frame: 1 year
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 3 Sep 2026.
- Results publication: PubMed 40372200Nasef AS, Tagrida IAE, Salman MF, Elatreisy A, Khaled SM. Buccal mucosal graft for onlay ureteroplasty in the management of proximal ureteral stricture. Single centre, prospective trial. Arch Ital Urol Androl. 2025 Jun 30;97(2):13695. doi: 10.4081/aiua.2025.13695. Epub 2025 May 15.
- Results publication: PubMed 10368190Naude JH. Buccal mucosal grafts in the treatment of ureteric lesions. BJU Int. 1999 May;83(7):751-4. doi: 10.1046/j.1464-410x.1999.00019.x.
- Results publication: PubMed 28220579Kocot A, Kalogirou C, Vergho D, Riedmiller H. Long-term results of ileal ureteric replacement: a 25-year single-centre experience. BJU Int. 2017 Aug;120(2):273-279. doi: 10.1111/bju.13825. Epub 2017 Mar 21.
- Results publication: PubMed 33258325Lee M, Lee Z, Koster H, Jun M, Asghar AM, Lee R, Strauss D, Patel N, Kim D, Komaravolu S, Drain A, Metro MJ, Zhao L, Stifelman M, Eun DD; Collaborative of Reconstructive Robotic Ureteral Surgery (CORRUS). Intermediate-term outcomes after robotic ureteral reconstruction for long-segment (>/=4 centimeters) strictures in the proximal ureter: A multi-institutional experience. Investig Clin Urol. 2021 Jan;62(1):65-71. doi: 10.4111/icu.20200298. Epub 2020 Nov 12.
- Results publication: PubMed 32377609Hefermehl LJ, Tritschler S, Kretschmer A, Beck V, Stief CG, Schlenker B, Strittmatter F. Open ureteroplasty with buccal mucosa graft for long proximal strictures: A good option for a rare problem. Investig Clin Urol. 2020 May;61(3):316-322. doi: 10.4111/icu.2020.61.3.316. Epub 2020 Mar 9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Buccal mucosal graft ureteroplasty in people with Ureter Stricture, run by Mohamed Salah Abdul Mawgoud.
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 7 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 AbdelMawgoud, Assistant lecturer (+201011486957, mo.salah@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success defined as ureteric patency without need for re-intervention (time frame: 1 year). The study lists 2 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 NCT07797829, 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 3 Sep 2026.