Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allium BUS | Experimental | Temporary urethral stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allium " Bulbar Urethral Stent " (BUS) system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One month after the surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of stents correctly positioned | Immediately after the surgical intervention | |
| Number of stent migrations | 1 month, 3 months, 6 months and 12 months after the surgical intervention | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27567746 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of stent removals performed without hemorrhage |
| 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 | Up to 12 months after the surgical intervention |
| Post-void residual volume measured by retrograde urinary urethrocystography | 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 | At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention |
| QUALIVEEN short form score (approved in French) | 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 | Up to 12 months following the surgical intervention |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided