TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation (TRESTRICTT)

May 9, 2019 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Les Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Sub-Investigator:
          • Christian SAUSSINE
        • Sub-Investigator:
          • Hervé LANG
        • Sub-Investigator:
          • Sébastien BERGERAT
        • Sub-Investigator:
          • Fleur STORY
        • Sub-Investigator:
          • Pierre MUNIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Thibault TRICARD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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