Urethral StrictureNCT04071925
9000 URETHRA STUDY: a Study About Urethroplasty for Urethral Stricture Disease
An observational study of Urethral Stricture, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Read more about this study
- Who is it for?
- Ages 6 to 100 years
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Urethroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2019to 31 Dec 2029
- 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 6 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Native men, native women, transmen, transwomen and children with urethral stricture disease.
Who may be able to join
- Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
- Patient age ≥ 6 years.
- If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.
Who cannot join
- Absence of signed written informed consent and thus a patient unwilling to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Dept. of Urology, Ghent University Hospital
Ghent, 9000
Nicolaas Lumen, +32 9 332 22 76, nicolaas.lumen@uzgent.be
Wesley Verla, +32 9 332 22 76, wesley.verla@uzgent.be
- Recruiting
University Hospital Ghent
Ghent, 9000
Wesley Verla, +32 332 22 83, wesley.verla@uzgent.be
About this study
Official title: 9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.
- Conditions
- Urethral Stricture
- Being tested
- Urethroplasty
- Keywords
- urethral stricture disease, urethral stricture, urethra, urethroplasty
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrethroplastyProcedure or surgery
Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival
Interval between operation and latest follow-up moment at which the patiënt remains failure-free
Measured: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively
Secondary outcomes (6)
Change in erectile function
Assessment preoperatively and postoperatively using the IIEF-5 (International Index of Erectile Function) questionnaire (a 5-item questionnaire, total score on 25, higher score indicating better erectile function).
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in ejaculatory function
Assessment preoperatively and postoperatively using the MSHQ-EjD (Male Sexual Health Questionnaire - Ejaculatory Dysfunction) short form questionnaire (a 3-item questionnaire, total score on 15, higher score indicating better ejaculatory function)
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in urinary function
Assessment preoperatively and postoperatively using the ICIQ-MLUTS (International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms) module questionnaire (a 6-item questionnaire, total score on 24, higher score indicating more urinary bother)
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in urinary continence
Assessment preoperatively and postoperatively using the ICIQ-UI (International Consultation on Incontinence Questionnaire - Urinary Incontinence) short form questionnaire (a 3-item questionnaire, total score on 21, higher score indicating more incontinence).
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in quality of life
Assessment preoperatively and postoperatively using the EQ-5D-3L questionnaire (a 5-item questionnaire generating a digit score, each of the 5 items can be scored with 1, 2 or 3 (e.g. 11213), higher digit score indicating lower quality of life).
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in general quality of life
Assessment preoperatively and postoperatively using the EQ-VAS (Visual Analogue Scale) (a numeric scale ranging from 0 to 100, higher score indicating better quality of life).
Measured: From the date of preoperative questionnaire completion until 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas Lumen, Principal investigator, University Hospital, GhentMarjan Waterloos, Study chair, University Hospital, GhentWesley Verla, Study director, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071925
- Sponsor's protocol ID
- B670201940616
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
- ClinicalTrials.gov ID
- NCT04071925
- Acronym / sponsor ID
- B670201940616
- Conditions
- Urethral Stricture
- Keywords
- urethral stricture disease, urethral stricture, urethra, urethroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Aug 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.
It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Native men, native women, transmen, transwomen and children with urethral stricture disease.
Key inclusion criteria (3 listed)
- Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
- Patient age ≥ 6 years.
- If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.
Key exclusion criteria (1 listed)
- Absence of signed written informed consent and thus a patient unwilling to participate.
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 |
|---|---|---|
| UrethroplastyOpen reconstructive surgery to restore urethral patency in case of urethral stricture disease. | Procedure or surgery | – |
Primary outcome
Failure-free survival
Time frame: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively
Interval between operation and latest follow-up moment at which the patiënt remains failure-free
6 secondary outcomes
Change in erectile function
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in ejaculatory function
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in urinary function
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in urinary continence
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in quality of life
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
Change in general quality of life
Time frame: From the date of preoperative questionnaire completion until 24 months postoperatively.
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 3 Jan 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.
Nicolaas Lumen principal investigator
University Hospital, Ghent
Marjan Waterloos study chair
University Hospital, Ghent
Wesley Verla study director
University Hospital, Ghent
2 sites 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 University Hospital, Ghent at 2 sites in Belgium.
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 3 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Contact Nicolaas Lumen (+32 9 332 22 76, nicolaas.lumen@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (time frame: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively). 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 3 Jan 2024.