Urethral StrictureNCT06362083
Urethral Stricture Database
An observational study of Urethral Stricture, run by Medical University of Graz at 1 site in Austria.
Trial summary
Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Questionnaires and data collection
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jan 2024to 15 Mar 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing urethral surgeries or interventions. All patients meeting the inclusion and exclusion criteria of the study should be informed about the possibility of participating in the study.
Who may be able to join
- All patients undergoing any of the following urethral surgeries are included:
- Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
- End-to-end anastomosis
- Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
- Urethral plastic surgeries with mesh graft
- Hypospadias corrections
- Boutonniere
- (Self) bougienage of the urethra
Who cannot join
- Lack of capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Röthl Martina Anna
Graz, Styria, 8036
Marianne Leitsmann, Prof. Dr., +43 316 385 80550, martina.roethl@medunigraz.at
Marianne Leitsmann, Prof. Dr.
About this study
Official title: Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.
Read the detailed description
The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.
In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.
The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.
- Conditions
- Urethral Stricture
- Being tested
- Questionnaires and data collection
- Keywords
- Reconstructive surgery, Quality of life, Perioperative Outcomes
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and data collectionOther
It is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of urethral reconstructive surgeries
Success is defined as a lack of stricture recurrence in the follow-up
Measured: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Secondary outcomes (3)
Complications of urethral reconstructive surgeries
Complications are defined as surgical site infection, fistula, problems at the preservation site of buccal mucosa.
Measured: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Sexual function after urethral reconstructive surgeries
Measured: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Health status after urethral reconstructive surgeries
Measured: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2034 (estimated)
- Study completion15 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362083
- Sponsor's protocol ID
- 34-317 ex 21/22
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT06362083
- Acronym / sponsor ID
- 34-317 ex 21/22
- Conditions
- Urethral Stricture
- Keywords
- Reconstructive surgery, Quality of life, Perioperative Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2034 (estimated)
- Study completion
- 15 Mar 2034 (estimated)
- First posted
- 12 Apr 2024 (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.
Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.
Detailed description
The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.
In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.
The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing urethral surgeries or interventions. All patients meeting the inclusion and exclusion criteria of the study should be informed about the possibility of participating in the study.
Key inclusion criteria (8 listed)
- Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
- End-to-end anastomosis
- Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
- Urethral plastic surgeries with mesh graft
- Hypospadias corrections
Key exclusion criteria (1 listed)
- Lack of capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and data collectionIt is a non-interventional, single-center, non-randomized, prospective observational study obtaining data and patient-reported outcomes. | Other | – |
Primary outcome
Success rate of urethral reconstructive surgeries
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Success is defined as a lack of stricture recurrence in the follow-up
3 secondary outcomes
Complications of urethral reconstructive surgeries
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Sexual function after urethral reconstructive surgeries
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Health status after urethral reconstructive surgeries
Time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
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 Urethral Stricture, run by Medical University of Graz at 1 site in Austria.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Apr 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of urethral reconstructive surgeries (time frame: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years). 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 12 Apr 2024.