NCT04161365

Brief Summary

In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to direct visual urethrotomy (DVIU) in the treatment of 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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

July 29, 2019

Last Update Submit

May 25, 2021

Conditions

Urethral StrictureFat Graft

Keywords

Urethral StrictureFat GraftDirect Visual Urethrotomy

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events at 3 months

    Types, severity and probability of procedure related adverse events

    3 months

  • Incidence of Treatment-Emergent Adverse Events at 12 months

    Types, severity and probability of procedure related adverse events

    12 months

Secondary Outcomes (6)

  • Change from Baseline Uroflowmetry at 3 months

    3 months

  • Change from Baseline Uroflowmetry at 12 months

    12 months

  • Change from Baseline IPSS at 3 months

    3 months

  • Change from Baseline IPSS at 12 months

    12 months

  • Change from Baseline Stricture Lumen diameter at 3 months

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Urethral stricture patients

EXPERIMENTAL

Patients suffering from urethral stricture are treated with direct visual internal urethrotomy (DVIU). Free fat graft is gathered from the abdominal subcutaneous fat. Fat graft is prepared and injected to the stricture site.

Procedure: Direct visual urethrotomyProcedure: Autologous fat grafting

Interventions

Direct visual urethrotomyPROCEDURE

Urethral stricture is treated with urethrotomy under visual control

Urethral stricture patients
Autologous fat graftingPROCEDURE

Autologous fat graft is gathered and injected to stricture

Urethral stricture patients

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urethral stricture that has re-occurred at least once.

You may not qualify if:

  • Malignant etiology of urethral stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pauliina Hartiala, Surgeon

    Turku University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hannes Kortekangas, Surgeon

CONTACT

+35823139192hannes.kortekangas@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery

Study Record Dates

First Submitted

July 29, 2019

First Posted

November 13, 2019

Study Start

May 28, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations

FI(1)