Urethral StricturePhase 2POIROTNCT04307537
Post-Operative Imaging After Urethroplasty With Peri-catheter Retrograde Urethrography Or Trial of Voiding With Voiding Cysto-urethrography
A Phase 2 study testing Post-urethroplasty urethrography in people with Urethral Stricture, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. 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?
- Post-urethroplasty urethrography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jan 2020to 1 Sep 2021
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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 (Appendix B).
- Age ≥ 18 years.
- Male patient.
- Anterior urethral stricture disease (penile, bulbar, penobulbar and panurethral strictures are allowed).
- Procedure was ended with leaving a transurethral catheter in place with foreseen catheter removal and early postoperative imaging after x days.
Who cannot join
- Absence of signed written informed consent (Appendix B).
- Age < 18 years.
- Female patients.
- Transgender patients.
- Posterior urethral stenosis
- Bladder neck reconstruction
- Patients in which no catheter has been left in place at the end of the procedure.
- Patients in which there is no need for early postoperative imaging, upon discretion of the treating clinician.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Dept. of Urology, Ghent University Hospital
Ghent, East-Flanders, 9000
About this study
Official title: POIROT TRIAL: Post-Operative Imaging After Urethroplasty With Peri-catheter Retrograde Urethrography Or Trial of Voiding With Voiding Cysto-urethrography
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. However, in order to do so, the clinician first wants to objectify whether the urethra has indeed healed sufficiently and therefore he/she can rely on early postoperative imaging.
Up until today, there is no clear standard about when and how to do early postoperative imaging and current practices are mainly based on expert opinion and habit. Basically, two strategies can be found amongst different urethroplasty centers: peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG). A pcRUG is performed by placing a small caliber tube (e.g. feeding tube 5 Fr) in the meatus urethrae of the patient, next to the transurethral catheter (which remains in place), and injecting contrast alongside the catheter. With a VCUG, contrast is injected through the transurethral catheter, up to the bladder. Thereafter, the catheter is removed and the patient is asked to urinate and thus to pass contrast through the urethra.
The primary end-point of this study is to compare 'the rightful decision to maintain the catheter at the time of imaging' between pcRUG only and pcRUG followed by VCUG in a within-patient fashion.
Read the detailed description
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. However, in order to do so, the clinician first wants to objectify whether the urethra has indeed healed sufficiently and therefore he/she can rely on early postoperative imaging.
Up until today, there is no clear standard about when and how to do early postoperative imaging and current practices are mainly based on expert opinion and habit. Basically, two strategies can be found amongst different urethroplasty centers: peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG). A pcRUG is performed by placing a small caliber tube (e.g. feeding tube 5 Fr) in the meatus urethrae of the patient, next to the transurethral catheter (which remains in place), and injecting contrast alongside the catheter. With a VCUG, contrast is injected through the transurethral catheter, up to the bladder. Thereafter, the catheter is removed and the patient is asked to urinate and thus to pass contrast through the urethra.
In both of the aforementioned imaging modalities, patients are installed similarly on the X-ray table and an antero-posterior X-ray image is made1. In patients with no or insignificant, wisp-like extravasation of contrast, the transurethral catheter can safely be removed. In case of significant contrast extravasation, as defined by Grossgold et al., the catheter is maintained or replaced for another week and one week later, imaging is repeated2.
Both pcRUG and VCUG are not perfect and involve a number of flaws. The main issue with pcRUG is represented by the potential impact of several variables on the image: different levels of pressure in the urethra by different strength of injection, different calibers of tubes through which the contrast is injected, etc. As regards VCUG, an important amount of patients does not achieve to void while being on the X-ray table, which can lead to a long duration of the procedure or even no imaging at all. Another important problem is the fact that if the patient has a significant extravasation of contrast, the catheter needs to be replaced through the freshly reconstructed, and apparently still leaking, urethra. This may be difficult and is often bothersome for the patient.
Given the drawbacks mentioned above, a combination of both techniques can be administered to overcome the flaws of each separate imaging modality and could as such be considered the standard of care in early postoperative imaging after urethroplasty. However, the combination of both techniques includes a higher exposure to radiation than one separate technique and one could wonder what the added value of VCUG after pcRUG is and whether or not this is worth the extra exposure to radiation. To date, there is no such data and a wide variability of strategies is used in the different urethroplasty practices worldwide.
Against this background, the primary end-point of this study is to compare 'the rightful decision to maintain the catheter at the time of imaging' between pcRUG only and pcRUG followed by VCUG in a within-patient fashion.
- Conditions
- Urethral Stricture
- Being tested
- Post-urethroplasty urethrography
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-urethroplasty urethrographyProcedure or surgery
Imaging of the urethra after reconstructive surgery to identify contrast leakage (no, insignificant, signficant).
| Study group | Role | What they receive |
|---|---|---|
| pcRUG | Experimental | Peri-catheter retrograde urethrography Receives: Procedure: Post-urethroplasty urethrography |
| VCUG | Active comparator | Voiding cysto-urethrography Receives: Procedure: Post-urethroplasty urethrography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of 'rightful decision to maintain the catheter at the time of imaging' between pcRUG only and VCUG.
In other words, the amount of catheters maintained during the investigation divided by the number of significant extravasations requiring perpetuated catheter stay.
Measured: 1 day (day of original investigation)
Secondary outcomes (5)
Difference in radiation exposure between pcRUG and VCUG expressed in mGy/(cm*cm)
Difference in dose of radiation exposure will be assessed with the Mann-Whitney U-test.
Measured: 1 day (moment of original investigation)
Difference in the amount of significant extravasations that is picked up with pcRUG versus VCUG.
Results of both pcRUG and VCUG will be shown to the treating clinician at least 4 weeks after the original investigation and the clinician will have to choose between 'no or insignificant contrast leakage' versus 'significant contrast leakage'.
Measured: Results of both pcRUG and VCUG will be shown to the treating clinician at least 4 weeks after the original investigation and the clinician will have to choose between 'no or insignificant contrast leakage' versus 'significant contrast leakage'.
Intra-observer variability of both pcRUG and VCUG
Reproducibility will be assessed with intraclass correlation coefficients. A threshold of >0.70 will be used as threshold for good intraclass correlation and thus good reproducibility.
Measured: First blinded assessment (at least 4 weeks after original investigation) versus second blinded assessment another 4 weeks later.
Inter-observer variability of both pcRUG and VCUG
Inter-observer variability will be assessed with Cohen's kappa. A threshold of >0.70 will be used for good inter-observer variability
Measured: Two experienced clinicians will be compared regarding decision making during the first blinded assessment (at least 4 weeks after the original investigation).
Amount of patients unable to void while being on the X-ray table
During VCUG, patients have to void after catheter removal to allow urethral imaging. Often, patients are unable to void while on the X-ray table.
Measured: 1 day (moment of original investigation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start21 Jan 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Within patient comparison
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307537
- Sponsor's protocol ID
- B670201942454
- Acronym
- POIROT
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2020
- Last updated
- 4 Jan 2023
- Results posted
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POIROT TRIAL: Post-Operative Imaging After Urethroplasty With Peri-catheter Retrograde Urethrography Or Trial of Voiding With Voiding Cysto-urethrography
- ClinicalTrials.gov ID
- NCT04307537
- Acronym / sponsor ID
- POIROT / B670201942454
- Conditions
- Urethral Stricture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 Mar 2020 (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.
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. However, in order to do so, the clinician first wants to objectify whether the urethra has indeed healed sufficiently and therefore he/she can rely on early postoperative imaging.
Up until today, there is no clear standard about when and how to do early postoperative imaging and current practices are mainly based on expert opinion and habit. Basically, two strategies can be found amongst different urethroplasty centers: peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG). A pcRUG is performed by placing a small caliber tube (e.g. feeding tube 5 Fr) in the meatus urethrae of the patient, next to the transurethral catheter (which remains in place), and injecting contrast alongside the catheter. With a VCUG, contrast is injected through the transurethral catheter, up to the bladder. Thereafter, the catheter is removed and the patient is asked to urinate and thus to pass contrast through the urethra.
The primary end-point of this study is to compare 'the rightful decision to maintain the catheter at the time of imaging' between pcRUG only and pcRUG followed by VCUG in a within-patient fashion.
Detailed description
After a reconstructive procedure of the urethra, a transurethral catheter is usually left in place to allow adequate healing of the tissues without exposure to urine. After 7-21 days, depending on several variables (e.g. type of reconstruction, stricture etiology, …), removal of the transurethral catheter is foreseen. However, in order to do so, the clinician first wants to objectify whether the urethra has indeed healed sufficiently and therefore he/she can rely on early postoperative imaging.
Up until today, there is no clear standard about when and how to do early postoperative imaging and current practices are mainly based on expert opinion and habit. Basically, two strategies can be found amongst different urethroplasty centers: peri-catheter retrograde urethrography (pcRUG) and voiding cysto-urethrography (VCUG). A pcRUG is performed by placing a small caliber tube (e.g. feeding tube 5 Fr) in the meatus urethrae of the patient, next to the transurethral catheter (which remains in place), and injecting contrast alongside the catheter. With a VCUG, contrast is injected through the transurethral catheter, up to the bladder. Thereafter, the catheter is removed and the patient is asked to urinate and thus to pass contrast through the urethra.
In both of the aforementioned imaging modalities, patients are installed similarly on the X-ray table and an antero-posterior X-ray image is made1. In patients with no or insignificant, wisp-like extravasation of contrast, the transurethral catheter can safely be removed. In case of significant contrast extravasation, as defined by Grossgold et al., the catheter is maintained or replaced for another week and one week later, imaging is repeated2.
Both pcRUG and VCUG are not perfect and involve a number of flaws. The main issue with pcRUG is represented by the potential impact of several variables on the image: different levels of pressure in the urethra by different strength of injection, different calibers of tubes through which the contrast is injected, etc. As regards VCUG, an important amount of patients does not achieve to void while being on the X-ray table, which can lead to a long duration of the procedure or even no imaging at all. Another important problem is the fact that if the patient has a significant extravasation of contrast, the catheter needs to be replaced through the freshly reconstructed, and apparently still leaking, urethra. This may be difficult and is often bothersome for the patient.
Given the drawbacks mentioned above, a combination of both techniques can be administered to overcome the flaws of each separate imaging modality and could as such be considered the standard of care in early postoperative imaging after urethroplasty. However, the combination of both techniques includes a higher exposure to radiation than one separate technique and one could wonder what the added value of VCUG after pcRUG is and whether or not this is worth the extra exposure to radiation. To date, there is no such data and a wide variability of strategies is used in the different urethroplasty practices worldwide.
Against this background, the primary end-point of this study is to compare 'the rightful decision to maintain the catheter at the time of imaging' between pcRUG only and pcRUG followed by VCUG in a within-patient fashion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within patient comparison
| Arm | Type | Receives |
|---|---|---|
| pcRUG | Experimental | Procedure: Post-urethroplasty urethrographyPeri-catheter retrograde urethrography |
| VCUG | Active comparator | Procedure: Post-urethroplasty urethrographyVoiding cysto-urethrography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B).
- Age ≥ 18 years.
- Male patient.
- Anterior urethral stricture disease (penile, bulbar, penobulbar and panurethral strictures are allowed).
- Procedure was ended with leaving a transurethral catheter in place with foreseen catheter removal and early postoperative imaging after x days.
Key exclusion criteria (8 listed)
- Absence of signed written informed consent (Appendix B).
- Age < 18 years.
- Female patients.
- Transgender patients.
- Posterior urethral stenosis
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 |
|---|---|---|
| Post-urethroplasty urethrographyImaging of the urethra after reconstructive surgery to identify contrast leakage (no, insignificant, signficant). | Procedure or surgery | VCUG, pcRUG |
Primary outcome
Percentage of 'rightful decision to maintain the catheter at the time of imaging' between pcRUG only and VCUG.
Time frame: 1 day (day of original investigation)
In other words, the amount of catheters maintained during the investigation divided by the number of significant extravasations requiring perpetuated catheter stay.
5 secondary outcomes
Difference in radiation exposure between pcRUG and VCUG expressed in mGy/(cm*cm)
Time frame: 1 day (moment of original investigation)
Difference in the amount of significant extravasations that is picked up with pcRUG versus VCUG.
Time frame: Results of both pcRUG and VCUG will be shown to the treating clinician at least 4 weeks after the original investigation and the clinician will have to choose between 'no or insignificant contrast leakage' versus 'significant contrast leakage'.
Intra-observer variability of both pcRUG and VCUG
Time frame: First blinded assessment (at least 4 weeks after original investigation) versus second blinded assessment another 4 weeks later.
Inter-observer variability of both pcRUG and VCUG
Time frame: Two experienced clinicians will be compared regarding decision making during the first blinded assessment (at least 4 weeks after the original investigation).
Amount of patients unable to void while being on the X-ray table
Time frame: 1 day (moment of original investigation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post-urethroplasty urethrography in people with Urethral Stricture, run by University Hospital, Ghent at 1 site 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 4 Jan 2023. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of 'rightful decision to maintain the catheter at the time of imaging' between pcRUG only and VCUG. (time frame: 1 day (day of original investigation)). 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 4 Jan 2023.