First or Second Uretral StenosisTRESTRICTTNCT03948009
TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
An observational study of First or Second Uretral Stenosis and Diagnosed With Uretral Fibroscopy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- First or Second Uretral Stenosis, Diagnosed With Uretral Fibroscopy
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Men between 18 and 80
- First or second uretral stenosis, diagnosed with uretral fibroscopy
Who cannot join
- Not multiple, strength or long stenosis
- No previous surgery of the urethra
- Refusal to participate to the study
- Inability to perform self-catheterization
Trial locations and contacts
1 site in 1 country.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient which continue clean intermittent self-catheterization.
Evaluation of patients tolerance with clean intermittent self-catheterization
Measured: 18 months
Secondary outcomes (2)
Comparaison of uroflowmetry
Evaluation of patients urinary profile
Measured: 18 months
Comparaison of Urinary Score Profile (USP)
Evaluation of patients quality of life
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start3 Aug 2020
- Primary completion3 Aug 2020
- Study completion17 Sep 2024
Why it stopped: The investigator did not have enough time to manage the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First or Second Uretral StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault TRICARD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948009
- Sponsor's protocol ID
- 7292
- Acronym
- TRESTRICTT
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2018
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation
- ClinicalTrials.gov ID
- NCT03948009
- Acronym / sponsor ID
- TRESTRICTT / 7292
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The investigator did not have enough time to manage the study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- Men between 18 and 80
- First or second uretral stenosis, diagnosed with uretral fibroscopy
Key exclusion criteria (4 listed)
- Not multiple, strength or long stenosis
- No previous surgery of the urethra
- Refusal to participate to the study
- Inability to perform self-catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient which continue clean intermittent self-catheterization.
Time frame: 18 months
Evaluation of patients tolerance with clean intermittent self-catheterization
2 secondary outcomes
Comparaison of uroflowmetry
Time frame: 18 months
Comparaison of Urinary Score Profile (USP)
Time frame: 18 months
Results and safety
The study was stopped early (reason given: The investigator did not have enough time to manage the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibault TRICARD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First or Second Uretral Stenosis and Diagnosed With Uretral Fibroscopy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The investigator did not have enough time to manage the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient which continue clean intermittent self-catheterization. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.