NCT07797829

Brief 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), 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)

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

September 3, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

August 27, 2026

Last Update Submit

September 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Surgical success defined as ureteric patency without need for re-intervention

    1 year

  • Surgical success defined as ureteric patency without need for re- intervention

    1 year

Study Arms (1)

Patients with proximal ureteric strictures

EXPERIMENTAL
Procedure: Buccal mucosal graft ureteroplasty

Interventions

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

Patients with proximal ureteric strictures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • Naude 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.

  • Kocot 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.

  • Lee 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.

  • Hefermehl 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.

Central Study Contacts

Mohamed AbdelMawgoud, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Last Updated

September 3, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share