Diagnosed With Uretral Fibroscopy Clinical Trial
— TRESTRICTTOfficial title:
TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
| NCT number | NCT03948009 |
| Other study ID # | 7292 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2019 |
| Est. completion date | June 2021 |
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | June 2021 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patient which continue clean intermittent self-catheterization. | Evaluation of patients tolerance with clean intermittent self-catheterization | 18 months | |
| Secondary | Comparaison of uroflowmetry | Evaluation of patients urinary profile | 18 months | |
| Secondary | Comparaison of Urinary Score Profile (USP) | Evaluation of patients quality of life | 18 months |