Detrusor Striated Sphincter Dyssynergia (DSSD)Phase 1/2ALLIUMNCT02323243
Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
A Phase 1/2 study testing Allium " Bulbar Urethral Stent " (BUS) system in people with Detrusor Striated Sphincter Dyssynergia (DSSD), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Detrusor Striated Sphincter Dyssynergia (DSSD)
- What is being tested?
- Allium " Bulbar Urethral Stent " (BUS) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to May 2016
- Phase
- Phase 1/2
- 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
- Male patient aged more than 18 years old
- Presenting detrusor striated sphincter dyssynergia in the opinion of the investigator, based on clinical data and proven urodynamically
- Detrusor striated sphincter dyssynergia with identified neurological origin
- With contraindication or failure of the conventional treatments
- Accepting the principle of the prosthetic incontinentation
- Having given his signed consent to participate in the study
- Affiliated with a social security scheme or assimilated.
Who cannot join
- Minor patient or protected adult according to the terms of the law
- Presenting contraindications to local regional anaesthesia
- Presenting contraindications or a previous failure to the treatment by prosthetic sphincterotomy
- Unable to hold a penile sheath.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. The standard treatment for DSSD is medical, either pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are unable to perform CISC and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.
Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. The Allium company has developed the " Bulbar Urethral Stent " (BUS) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. In order to quantify the interest of the BUS system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.
- Being tested
- Allium " Bulbar Urethral Stent " (BUS) system
- Keywords
- Detrusor striated sphincter dyssynergia, Temporary urethral stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allium " Bulbar Urethral Stent " (BUS) systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Allium BUS | Experimental | Temporary urethral stent Receives: Device: Allium " Bulbar Urethral Stent " (BUS) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who perceive their voiding condition improved or very improved
The perception of voiding condition by the patient will be measured with a 5-point Likert Scale. The patient will have to define the voiding condition compared to the initial (pre-procedure), as: very worse, worse, non-changed, improved, or very improved
Measured: One month after the surgical intervention
Secondary outcomes (8)
Number of stents correctly positioned
Measured: Immediately after the surgical intervention
Number of stent migrations
Measured: 1 month, 3 months, 6 months and 12 months after the surgical intervention
Number of stent removals performed without hemorrhage
Measured: 12 months after the surgical intervention
Number of complications, i.e. symptomatic urinary tract infections, encrustations, stenosis and hematuria, need for re-intervention and removals of the stent
Measured: Up to 12 months after the surgical intervention
Post-void residual volume measured by retrograde urinary urethrocystography
Measured: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Maximum detrusor pressure and maximum urethral closure pressure, measured during the urodynamic testing
Measured: At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention
QUALIVEEN short form score (approved in French)
Measured: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Number of patients requesting a change in the voiding method, i.e. premature removal of the stent
Measured: Up to 12 months following the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Detrusor Striated Sphincter Dyssynergia (DSSD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323243
- Sponsor's protocol ID
- 2014.861
- Acronym
- ALLIUM
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2014
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Matillon X, Terrier JE, Arnouil N, Lalloue F, Pic G, Ruffion A. [Temporary urethral stents ALLIUM BUS "BULBAR URETHRAL STENT" for the treatment of detrusor sphincter dyssynergia]. Prog Urol. 2016 Sep;26(9):532-7. doi: 10.1016/j.purol.2016.07.005. Epub 2016 Aug 24. French.
PubMed 27567746
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
- ClinicalTrials.gov ID
- NCT02323243
- Acronym / sponsor ID
- ALLIUM / 2014.861
- Keywords
- Detrusor striated sphincter dyssynergia, Temporary urethral stent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. The standard treatment for DSSD is medical, either pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are unable to perform CISC and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.
Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. The Allium company has developed the " Bulbar Urethral Stent " (BUS) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. In order to quantify the interest of the BUS system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allium BUS | Experimental | Device: Allium " Bulbar Urethral Stent " (BUS) systemTemporary urethral stent |
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)
- Male patient aged more than 18 years old
- Presenting detrusor striated sphincter dyssynergia in the opinion of the investigator, based on clinical data and proven urodynamically
- Detrusor striated sphincter dyssynergia with identified neurological origin
- With contraindication or failure of the conventional treatments
- Accepting the principle of the prosthetic incontinentation
Key exclusion criteria (4 listed)
- Minor patient or protected adult according to the terms of the law
- Presenting contraindications to local regional anaesthesia
- Presenting contraindications or a previous failure to the treatment by prosthetic sphincterotomy
- Unable to hold a penile sheath.
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 |
|---|---|---|
| Allium " Bulbar Urethral Stent " (BUS) system | Device | Allium BUS |
Primary outcome
Percentage of patients who perceive their voiding condition improved or very improved
Time frame: One month after the surgical intervention
The perception of voiding condition by the patient will be measured with a 5-point Likert Scale. The patient will have to define the voiding condition compared to the initial (pre-procedure), as: very worse, worse, non-changed, improved, or very improved
8 secondary outcomes
Number of stents correctly positioned
Time frame: Immediately after the surgical intervention
Number of stent migrations
Time frame: 1 month, 3 months, 6 months and 12 months after the surgical intervention
Number of stent removals performed without hemorrhage
Time frame: 12 months after the surgical intervention
Number of complications, i.e. symptomatic urinary tract infections, encrustations, stenosis and hematuria, need for re-intervention and removals of the stent
Time frame: Up to 12 months after the surgical intervention
Post-void residual volume measured by retrograde urinary urethrocystography
Time frame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Maximum detrusor pressure and maximum urethral closure pressure, measured during the urodynamic testing
Time frame: At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention
QUALIVEEN short form score (approved in French)
Time frame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Number of patients requesting a change in the voiding method, i.e. premature removal of the stent
Time frame: Up to 12 months following the surgical intervention
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 11 Sep 2025.
- Results publication: PubMed 27567746Matillon X, Terrier JE, Arnouil N, Lalloue F, Pic G, Ruffion A. [Temporary urethral stents ALLIUM BUS "BULBAR URETHRAL STENT" for the treatment of detrusor sphincter dyssynergia]. Prog Urol. 2016 Sep;26(9):532-7. doi: 10.1016/j.purol.2016.07.005. Epub 2016 Aug 24. French.
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 1/2 study testing Allium " Bulbar Urethral Stent " (BUS) system in people with Detrusor Striated Sphincter Dyssynergia (DSSD), run by Hospices Civils de Lyon at 1 site in France.
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 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 11 Sep 2025. 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 France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 patients who perceive their voiding condition improved or very improved (time frame: One month after the surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323243, which also lists 1 linked publication.
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 11 Sep 2025.