NCT07436819

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 4, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

double-face urethroplastybuccal mucosal graft

Outcome Measures

Primary Outcomes (1)

  • Urethral patency

    Urethral patency will be evaluated by Uroflowmetry, and Urethrography

    at least 2 years

Study Arms (1)

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.

Procedure: Double-face augmentation urethroplasty

Interventions

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.

bulbar urethral stricture disease

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include patients with long segment bulbar urethral stricture (\>2 cm).Urethral lumen size less than 6 Fr.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Menoufia faculty of medicine

Shibīn al Kawm, Al-Minoufiya, 52314, Egypt

Location

Menoufia faculty of medicine

Shibīn al Kawm, Al-Minufia, 52314, Egypt

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 27, 2026

Study Start

February 1, 2025

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations