Clinical trial NCT02323243: Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
Official title: Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Detrusor Striated Sphincter Dyssynergia (DSSD)
Keywords: Detrusor striated sphincter dyssynergia
Temporary urethral stent
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients who perceive their voiding condition improved or very improved
timeFrame: One month after the surgical intervention
Secondary outcomes:
measure: Number of stents correctly positioned
timeFrame: Immediately after the surgical intervention
measure: Number of stent migrations
timeFrame: 1 month, 3 months, 6 months and 12 months after the surgical intervention
measure: Number of stent removals performed without hemorrhage
timeFrame: 12 months after the surgical intervention
measure: Number of complications, i.e. symptomatic urinary tract infections, encrustations, stenosis and hematuria, need for re-intervention and removals of the stent
timeFrame: Up to 12 months after the surgical intervention
measure: Post-void residual volume measured by retrograde urinary urethrocystography
timeFrame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
measure: Maximum detrusor pressure and maximum urethral closure pressure, measured during the urodynamic testing
timeFrame: At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention
measure: QUALIVEEN short form score (approved in French)
timeFrame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
measure: Number of patients requesting a change in the voiding method, i.e. premature removal of the stent
timeFrame: Up to 12 months following the surgical intervention
Other outcomes:
Locations:
city: Pierre Bénite cedex
country: France
facility: Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud
Study officials:
References: