NCT06192654

Brief Summary

The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 21, 2023

Last Update Submit

December 21, 2023

Conditions

Urethral Stricture, Male

Keywords

urethral stricture

Outcome Measures

Primary Outcomes (1)

  • Urethral patency

    A peri-urethrogram will be performed prior to catheter removal

    4 weeks post-surgery

Secondary Outcomes (4)

  • Serious adverse events

    4 weeks post-surgery

  • Voiding symptoms

    2 months up-to 5 years post-surgery

  • Urine flow

    2 months up-to 5 years post-surgery

  • Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)

    Through study completion, an average of up to 5 years

Study Arms (2)

Small intestinal submucosa (SIS) graft urethroplasty

EXPERIMENTAL

this group will use a small intestinal submucosa graft in urethroplasty.

Procedure: Small intestinal submucosa (SIS) graft urethroplasty

Autologous oral bucal mucosa graft urethroplasty

ACTIVE COMPARATOR

this group will use an autologous oral bucal mucosa graft in urethroplasty.

Procedure: Autologous oral bucal mucosa graft urethroplasty

Interventions

Small intestinal submucosa (SIS) graft urethroplastyPROCEDURE

Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the small intestinal submucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location.

Small intestinal submucosa (SIS) graft urethroplasty
Autologous oral bucal mucosa graft urethroplastyPROCEDURE

Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. The autologous oral bucal mucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location.

Autologous oral bucal mucosa graft urethroplasty

Eligibility Criteria

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

You may qualify if:

  • Patients signed informed consent form
  • Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
  • Patients undergoing substitution urethroplasty for urethral stricture.

You may not qualify if:

  • Patients without surgical indication
  • Subtotal and total urethral strictures
  • Radiation therapy to the abdomen or pelvis
  • Lichen sclerosis related strictures
  • Patients with previous hypospadias repair
  • Neurogenic urinary tract disorders
  • Mental disorders
  • Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
  • Patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system.
  • Patient with malignant tumor
  • Patient who cannot be regularly examined due to any circumstances
  • Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, China

Location

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

November 10, 2023

Primary Completion

October 20, 2025

Study Completion

December 30, 2025

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations

CN(1)