TREatment of Uretral STRICTure With Self-catheterization... | NCT03948009

Studies
TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation

NCT03948009

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Sep 20, 2024Actual

Enrollment

20Actual

Phase

Not provided

Conditions

First or Second Uretral Stenosis
Diagnosed With Uretral Fibroscopy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigator did not have enough time to manage the study.

Expanded Access Info

Start Date

Aug 3, 2020Actual

Primary Completion Date

Aug 3, 2020Actual

Completion Date

Sep 17, 2024Actual

First Submitted Date

Nov 22, 2018

First Submission Date that Met QC Criteria

May 9, 2019

First Posted Date

May 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2024

Last Update Posted Date

Sep 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Urethral stenosis has a recurrent character. The clean intermittent self-catheterization can be proposed for repeat stenosis. This study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient which continue clean intermittent self-catheterization.	Evaluation of patients tolerance with clean intermittent self-catheterization	18 months

Secondary Outcomes

Measure	Description	Time Frame
Comparaison of uroflowmetry	Evaluation of patients urinary profile	18 months
Comparaison of Urinary Score Profile (USP)	Evaluation of patients quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Men between 18 and 80
First or second uretral stenosis, diagnosed with uretral fibroscopy

Exclusion criteria:

Not multiple, strength or long stenosis
No previous surgery of the urethra
Refusal to participate to the study
Inability to perform self-catheterization

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Men between 18 and 80 First or second uretral stenosis, diagnosed with uretral fibroscopy

Not multiple, strength or long stenosis No previous surgery of the urethra

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thibault TRICARD	Les Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Les Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided