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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948009
Recruitment Status : Unknown
Verified May 2019 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.

Condition or disease
First or Second Uretral Stenosis Diagnosed With Uretral Fibroscopy

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : June 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patient which continue clean intermittent self-catheterization. [ Time Frame: 18 months ]
    Evaluation of patients tolerance with clean intermittent self-catheterization


Secondary Outcome Measures :
  1. Comparaison of uroflowmetry [ Time Frame: 18 months ]
    Evaluation of patients urinary profile

  2. Comparaison of Urinary Score Profile (USP) [ Time Frame: 18 months ]
    Evaluation of patients quality of life


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948009


Contacts
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Contact: Thibault TRICARD +33 3 69 55 05 35 thibault.tricard@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Contact: Thibault TRICARD    +33 3 69 55 05 35    thibault.tricard@chru-strasbourg.fr   
Sub-Investigator: Christian SAUSSINE         
Sub-Investigator: Hervé LANG         
Sub-Investigator: Sébastien BERGERAT         
Sub-Investigator: Fleur STORY         
Sub-Investigator: Pierre MUNIER         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Thibault TRICARD Les Hôpitaux Universitaires de Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03948009    
Other Study ID Numbers: 7292
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical