Urethra StenosisDoVeNCT04551417
DoVe Trial: Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures
A study testing Free graft urethroplasty in people with Urethra Stenosis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethra Stenosis
- What is being tested?
- Free graft urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Mar 2020to 1 Jan 2026
- 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
- 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.
- Fit for operation, based on the surgeon's expert opinion.
- Isolated bulbar urethral stricture confirmed by imaging.
- Preputium, penile shaft skin, buccal mucosa and lingual mucosa are allowed as free graft material in the executed dorsal onlay or ventral onlay FGU.
- Patient is able and willing to attend the follow-up consultations.
Who cannot join
- Absence of signed written informed consent (Appendix B).
- Age < 18 years.
- Female patients.
- Transgender patients.
- Patients unfit for operation.
- Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck).
Show all 16Show fewer
- A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck).
- Prior bulbar urethroplasty.
- Lichen Sclerosus related strictures.
- Strictures after failed hypospadias repair.
- Patients with neurogenic bladder.
- History of pelvic radiation therapy.
- Shift of technique to any other technique than dorsal or ventral onlay FGU due to any circumstance (post-hoc exclusion).
- Utilization of free graft material other than preputium, penile shaft skin, buccal mucosa or lingual mucosa.
- Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
- Patient declares that it will be impossible for him to attend the follow-up consultations.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Wesley Verla, +32 9 332 22 76, wesley.verla@uzgent.be
Nicolaas Lumen, +32 9 332 22 76, nicolaas.lumen@uzgent.be
About this study
Official title: DoVe Trial: a Randomized Controlled Trial Comparing Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures
For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.
Read the detailed description
Urethral stricture disease is a common urological condition in men. Although rigorous epidemiologic data is sparse, the existing papers report an incidence varying between 0.6 and 1.4 percent1. Urethral strictures can occur throughout the entire length of the urethra, but mainly involve the anterior urethra and, in particular, the bulbar segment2.
The International Consultation on Urologic Diseases (ICUD) recommends anastomotic repair (AR) urethroplasty for isolated, short, bulbar urethral strictures3. However, AR urethroplasty is only possible up to a certain point of stricture length. The elasticity of the bulbar urethra is estimated to be about 25% and given the average bulbar urethral length of 10 cm, one could simply calculate that strictures up to 2.5 cm can be treated with AR urethroplasty. However, this border of 2.5 cm is rather arbitrary as additional length may be gained through the different maneuvers of Webster et al., enabling the option of AR for even longer strictures4. Furthermore, the location of the stricture within the bulbar segment plays an important role as well: a proximal bulbar stricture location allows AR for longer strictured segments (> 2.5 cm) than a more distal stricture location which nears the penoscrotal angle. Anyhow, the key for a successful AR procedure is to perform a well-vascularized and tension-free anastomosis5. Whenever this is impossible to achieve, even after performing the length-gaining maneuvers of Webster et al., it is recommended to perform a so-called 'substitution urethroplasty' in which the strictured area of the urethra is opened and augmented with a free graft or a pedicled flap5.
Within the option of substitution urethroplasty, free graft urethroplasty (FGU) definitely represents the easiest and most straightforward treatment option. Herein, urethral surgeons initially started by placing grafts ventrally 'on' the urethra: 'ventral onlay FGU'. Later, Barbagli et al. started placing grafts dorsally: 'dorsal onlay FGU'6. They advocated that this dorsal graft position would lead to better graft anchorage, less graft mobility and less graft sacculation. However, to date, there is no indisputable data to support the choice of one technique over another, not from a surgical point of view, nor from a functional point of view7. Furthermore, studies investigating this issue are mostly retrospective and thus only entail a low level of evidence7.
Against this background, the aim of the DoVe trial is to directly compare dorsal onlay and ventral onlay FGU for both surgical and functional outcome.
- Conditions
- Urethra Stenosis
- Being tested
- Free graft 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.
Free graft urethroplastyProcedure or surgery
Free graft urethroplasty will be performed either with ventral or dorsal onlay of the graft.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal onlay graft urethroplasty | Active comparator | Not described Receives: Procedure: Free graft urethroplasty |
| Ventral onlay graft urethroplasty | Experimental | Not described Receives: Procedure: Free graft urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival after 24 months
Failure is defined as the inability to pass a flexible 16 Fr cystoscope through the reconstructed area without damaging the urethral mucosa.
Measured: 24 months
Secondary outcomes (10)
Change in postoperative erectile function
Assessed with IIEF 5 questionnaire (international index on erectile function: score between 5 and 25, higher scores indicating better erectile function)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in ejaculatory function
Assessed with MSHQ-EjD short form questionnaire (male sexual health questionnaire - ejaculatory dysfunction short form: score between 1 and 15, higher scores indicating better ejaculatory function)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in LUTS
Assessed with Peeling's voiding picture (score between 1 and 4, lower scores indicating better strength of the urinary stream)
Measured: Baseline question, followed by question at 3, 12 and 24 months of follow-up.
Change in LUTS
Assessed with ICIQ-MLUTS module (international consultation on incontinence questionnaire - male lower urinary tract symptoms: score between 0 and 24, higher scores indicating more LUTS)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in urinary continence
Assessed with ICIQ-UI short form questionnaire (international consultation on incontinence questionnaire - urinary incontinence: score between 0 and 21, higher scores indicating more urinary incontinence)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in maximum flow rate
Assessed with uroflowmetry (Qmax)
Measured: Uroflowmetry at baseline, followed by uroflowmetry at 3, 12 and 24 months of follow-up.
Change in quality of life
Assessed with EQ-5D-3L (5 questions on quality of life resulting in digit score, e.g. 11231, higher scores indicating worse quality of life)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in quality of life
Assessed with EQ-VAS (EQ-visual analogue scale: scale between 0 and 100, higher scores indicating better quality of life)
Measured: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Patient satisfaction
Assessed with two general patient satisfaction questions
Measured: Assessed after 3, 12 and 24 months of follow-up.
Postoperative complication rate
Categorized according to the Clavien-Dindo classification system
Measured: Within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start4 Mar 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethra StenosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 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, GhentWesley Verla, Study director, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551417
- Sponsor's protocol ID
- BC-06890
- Acronym
- DoVe
- Status last verified
- Jan 2024
- First submitted
- 29 Jun 2020
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DoVe Trial: a Randomized Controlled Trial Comparing Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures
- ClinicalTrials.gov ID
- NCT04551417
- Acronym / sponsor ID
- DoVe / BC-06890
- Conditions
- Urethra Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Sep 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.
For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.
Detailed description
Urethral stricture disease is a common urological condition in men. Although rigorous epidemiologic data is sparse, the existing papers report an incidence varying between 0.6 and 1.4 percent1. Urethral strictures can occur throughout the entire length of the urethra, but mainly involve the anterior urethra and, in particular, the bulbar segment2.
The International Consultation on Urologic Diseases (ICUD) recommends anastomotic repair (AR) urethroplasty for isolated, short, bulbar urethral strictures3. However, AR urethroplasty is only possible up to a certain point of stricture length. The elasticity of the bulbar urethra is estimated to be about 25% and given the average bulbar urethral length of 10 cm, one could simply calculate that strictures up to 2.5 cm can be treated with AR urethroplasty. However, this border of 2.5 cm is rather arbitrary as additional length may be gained through the different maneuvers of Webster et al., enabling the option of AR for even longer strictures4. Furthermore, the location of the stricture within the bulbar segment plays an important role as well: a proximal bulbar stricture location allows AR for longer strictured segments (> 2.5 cm) than a more distal stricture location which nears the penoscrotal angle. Anyhow, the key for a successful AR procedure is to perform a well-vascularized and tension-free anastomosis5. Whenever this is impossible to achieve, even after performing the length-gaining maneuvers of Webster et al., it is recommended to perform a so-called 'substitution urethroplasty' in which the strictured area of the urethra is opened and augmented with a free graft or a pedicled flap5.
Within the option of substitution urethroplasty, free graft urethroplasty (FGU) definitely represents the easiest and most straightforward treatment option. Herein, urethral surgeons initially started by placing grafts ventrally 'on' the urethra: 'ventral onlay FGU'. Later, Barbagli et al. started placing grafts dorsally: 'dorsal onlay FGU'6. They advocated that this dorsal graft position would lead to better graft anchorage, less graft mobility and less graft sacculation. However, to date, there is no indisputable data to support the choice of one technique over another, not from a surgical point of view, nor from a functional point of view7. Furthermore, studies investigating this issue are mostly retrospective and thus only entail a low level of evidence7.
Against this background, the aim of the DoVe trial is to directly compare dorsal onlay and ventral onlay FGU for both surgical and functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal onlay graft urethroplasty | Active comparator | Procedure: Free graft urethroplasty |
| Ventral onlay graft urethroplasty | Experimental | Procedure: Free graft urethroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- Fit for operation, based on the surgeon's expert opinion.
- Isolated bulbar urethral stricture confirmed by imaging.
Key exclusion criteria (16 listed)
- Absence of signed written informed consent (Appendix B).
- Age < 18 years.
- Female patients.
- Transgender patients.
- Patients unfit for operation.
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 |
|---|---|---|
| Free graft urethroplastyFree graft urethroplasty will be performed either with ventral or dorsal onlay of the graft. | Procedure or surgery | Dorsal onlay graft urethroplasty, Ventral onlay graft urethroplasty |
Primary outcome
Failure-free survival after 24 months
Time frame: 24 months
Failure is defined as the inability to pass a flexible 16 Fr cystoscope through the reconstructed area without damaging the urethral mucosa.
10 secondary outcomes
Change in postoperative erectile function
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in ejaculatory function
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in LUTS
Time frame: Baseline question, followed by question at 3, 12 and 24 months of follow-up.
Change in LUTS
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in urinary continence
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in maximum flow rate
Time frame: Uroflowmetry at baseline, followed by uroflowmetry at 3, 12 and 24 months of follow-up.
Change in quality of life
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in quality of life
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Patient satisfaction
Time frame: Assessed after 3, 12 and 24 months of follow-up.
Postoperative complication rate
Time frame: Within 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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. This study is not recruiting at the moment.
Nicolaas Lumen principal investigator
University Hospital, Ghent
Wesley Verla study director
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free graft urethroplasty in people with Urethra Stenosis, 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 31 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 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?
Results are not available in the source record.
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 after 24 months (time frame: 24 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 31 Jan 2024.