Anterior Urethral Stricture, MalePASTISNCT04452890
Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures.
A study testing Sonourethrography in people with Anterior Urethral Stricture, Male, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The choice of the best surgical technique for urethral stricture repair depends on the stricture length. Estimating the length of urethral strictures is therefore of utmost importance. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Anterior Urethral Stricture, Male
- What is being tested?
- Sonourethrography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- 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
- Age: 18 years or older
- Anterior urethral strictures (except for meatal strictures)
Who cannot join
- Posterior urethral strictures
- Meatal strictures
- History of hypospadias repair
- History of phalloplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PASTIS-Trial: Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures: A Prospective Feasibility Trial
The choice of the best surgical technique for urethral stricture repair depends on the stricture length. Estimating the length of urethral strictures is therefore of utmost importance.
Different clinical studies have proven that SUG has a higher sensitivity to evaluate the length of urethral strictures compared to RUG or VCUG.
The goal of this study is to assess the feasibility of using SUG as single pre-operative assessment tool in patients with suspicion of anterior urethral strictures. In this way, use of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior urethral strictures, thereby avoiding significant radiation load of patients.
Read the detailed description
Urethral stricture disease (USD) is a medical condition in which a narrowing of the urethral lumen occurs due to pathological fibrosis and cicatrix formation of the urethral mucosa and surrounding spongious tissue (spongiofibrosis). Urethral strictures may occur at any location from the bladder neck to the external urethral meatus and are categorized based on their localisation in anterior strictures (including the urethral meatus, penile urethra and bulbar urethra) and posterior strictures (including the prostatic urethra and membranous urethra). USD is a disease of all ages but the prevalence increases with increasing age since the cumulative risk of having had urethral instrumentation equally increases. All processes that cause urethral trauma may provoke USD. The majority of strictures nowadays is idiopathic or caused by iatrogenic trauma of the urethra.
The pathological narrowing of the urethral lumen can lead to a wide variety of symptoms which ask for specific diagnostic investigations, in which imaging of the urethra plays a central role. Retrograde urethrography (RUG) and voiding cystourethrography (VCUG) are considered to be the gold standard diagnostic investigation techniques for diagnosis of USD.
In both techniques, contrast is instilled in the urethra through the urethral meatus and radiographic imaging is used to visualize the urethra. RUG and VCUG offer the possibility to visualize the urethra completely and to evaluate the number, length and location of urethral strictures. On the other hand, these techniques have some crucial disadvantages. First and foremost, the radiation load of the genitopelvic region in often young patients is inevitable in RUG and VCUG. Secondly, it is impossible to evaluate the degree of spongiofibrosis with radiographic imaging.
In 1988, McAnnich, et al. were the first to describe sonourethrography (SUG) for the diagnosis of anterior urethral strictures in males. In this technique, a Foley catheter is inserted in the urethral meatus and a physiological solution is instilled in the urethra while a linear 7,5 MHz ultrasound probe is placed sagitally over the course of the urethra. SUG is not only able to evaluate the length and localization of a US, but it also enables the investigator to evaluate the grade of spongiofibrosis.
Different strudies have shown that SUG has a higher sensitivity for the measurement of urethral stricture length compared to classical radiographic imaging such as RUG or VCUG. Since the choice of the most adequate surgical technique depends on the length of the urethral stricture, correct estimation of the urethral stricture length is of the utmost importance.
The goal of this study is to evaluate the feasibility of the use of sonourethrography as single diagnostic tool in the pre-operative diagnostic work-up of males with suspicion of anterior urethral strictures. In this way, classic radiographic imaging such as RUG and VCUG could be omitted in these patients, saving them from a significant radiation load.
Fifty patients with penile strictures and fifty patients with bulbar strictures will be included in this study. When 50% of patients (25 penile and 25 bulbar strictures) have completed the study, an interim analysis will be conducted. If this analysis shows that RUG or VCUG can be omitted in 80% or more of patients, the study will be stopped.
- Conditions
- Anterior Urethral Stricture, Male
- Being tested
- Sonourethrography
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonourethrographyDiagnostic test
Ultrasound of the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Sonourethrography | Experimental | Ultrasound of the urethra (Sonourethrography - SUG): In this procedure, a Foley catheter is inserted into the top of the urethra and physiological serum is instilled into the urethra while a linear 7.5 MHz ultrasound probe is placed sagitally on the course of the urethra to detect a narrowing of the urethra. Receives: Diagnostic Test: Sonourethrography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate
To evaluate the proportion of patients in whom the pre-operative surgical treatment planning was accurate based on sonourethrography only.
Measured: 2 years
Secondary outcomes (1)
Identification of predictors for failure of treatment planning by sonourethrography by regression analysis.
To evaluate which factors are predictive for failure of treatment planning by sonourethrography only.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Urethral Stricture, MaleStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, prospective feasibility trial
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT04452890
- Sponsor's protocol ID
- BC-06980-ADP
- Acronym
- PASTIS
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASTIS-Trial: Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures: A Prospective Feasibility Trial
- ClinicalTrials.gov ID
- NCT04452890
- Acronym / sponsor ID
- PASTIS / BC-06980-ADP
- Conditions
- Anterior Urethral Stricture, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Jul 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.
The choice of the best surgical technique for urethral stricture repair depends on the stricture length. Estimating the length of urethral strictures is therefore of utmost importance.
Different clinical studies have proven that SUG has a higher sensitivity to evaluate the length of urethral strictures compared to RUG or VCUG.
The goal of this study is to assess the feasibility of using SUG as single pre-operative assessment tool in patients with suspicion of anterior urethral strictures. In this way, use of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior urethral strictures, thereby avoiding significant radiation load of patients.
Detailed description
Urethral stricture disease (USD) is a medical condition in which a narrowing of the urethral lumen occurs due to pathological fibrosis and cicatrix formation of the urethral mucosa and surrounding spongious tissue (spongiofibrosis). Urethral strictures may occur at any location from the bladder neck to the external urethral meatus and are categorized based on their localisation in anterior strictures (including the urethral meatus, penile urethra and bulbar urethra) and posterior strictures (including the prostatic urethra and membranous urethra). USD is a disease of all ages but the prevalence increases with increasing age since the cumulative risk of having had urethral instrumentation equally increases. All processes that cause urethral trauma may provoke USD. The majority of strictures nowadays is idiopathic or caused by iatrogenic trauma of the urethra.
The pathological narrowing of the urethral lumen can lead to a wide variety of symptoms which ask for specific diagnostic investigations, in which imaging of the urethra plays a central role. Retrograde urethrography (RUG) and voiding cystourethrography (VCUG) are considered to be the gold standard diagnostic investigation techniques for diagnosis of USD.
In both techniques, contrast is instilled in the urethra through the urethral meatus and radiographic imaging is used to visualize the urethra. RUG and VCUG offer the possibility to visualize the urethra completely and to evaluate the number, length and location of urethral strictures. On the other hand, these techniques have some crucial disadvantages. First and foremost, the radiation load of the genitopelvic region in often young patients is inevitable in RUG and VCUG. Secondly, it is impossible to evaluate the degree of spongiofibrosis with radiographic imaging.
In 1988, McAnnich, et al. were the first to describe sonourethrography (SUG) for the diagnosis of anterior urethral strictures in males. In this technique, a Foley catheter is inserted in the urethral meatus and a physiological solution is instilled in the urethra while a linear 7,5 MHz ultrasound probe is placed sagitally over the course of the urethra. SUG is not only able to evaluate the length and localization of a US, but it also enables the investigator to evaluate the grade of spongiofibrosis.
Different strudies have shown that SUG has a higher sensitivity for the measurement of urethral stricture length compared to classical radiographic imaging such as RUG or VCUG. Since the choice of the most adequate surgical technique depends on the length of the urethral stricture, correct estimation of the urethral stricture length is of the utmost importance.
The goal of this study is to evaluate the feasibility of the use of sonourethrography as single diagnostic tool in the pre-operative diagnostic work-up of males with suspicion of anterior urethral strictures. In this way, classic radiographic imaging such as RUG and VCUG could be omitted in these patients, saving them from a significant radiation load.
Fifty patients with penile strictures and fifty patients with bulbar strictures will be included in this study. When 50% of patients (25 penile and 25 bulbar strictures) have completed the study, an interim analysis will be conducted. If this analysis shows that RUG or VCUG can be omitted in 80% or more of patients, the study will be stopped.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, prospective feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Sonourethrography | Experimental | Diagnostic Test: SonourethrographyUltrasound of the urethra (Sonourethrography - SUG): In this procedure, a Foley catheter is inserted into the top of the urethra and physiological serum is instilled into the urethra while a linear 7.5 MHz ultrasound probe is placed sagitally on the course of the urethra to detect a narrowing of the urethra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 years or older
- Anterior urethral strictures (except for meatal strictures)
Key exclusion criteria (4 listed)
- Posterior urethral strictures
- Meatal strictures
- History of hypospadias repair
- History of phalloplasty
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 |
|---|---|---|
| SonourethrographyUltrasound of the urethra. | Diagnostic test | Sonourethrography |
Primary outcome
Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate
Time frame: 2 years
To evaluate the proportion of patients in whom the pre-operative surgical treatment planning was accurate based on sonourethrography only.
1 secondary outcome
Identification of predictors for failure of treatment planning by sonourethrography by regression analysis.
Time frame: 2 years
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 7 Dec 2022.
Related trials for Anterior Urethral Stricture, Male
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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 study testing Sonourethrography in people with Anterior Urethral Stricture, Male, 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 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: finished, as of the sponsor's last update on 7 Dec 2022. 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.
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?
Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate (time frame: 2 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 7 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.