A Phase 1/2 interventional study of Allium " Bulbar Urethral Stent " (BUS) system in Detrusor Striated Sphincter Dyssynergia (DSSD), sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Hospices Civils de Lyon · Phase 1/2, Interventional, and Treatment
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.
Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Temporary urethral stent
Device: Allium " Bulbar Urethral Stent " (BUS) system
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
Time frame: One month after the surgical intervention
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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon