Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia (ALLIUM)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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 design
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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