Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia (ALLIUM)

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 Overview

• Status: Completed
• Conditions: Detrusor Striated Sphincter Dyssynergia (DSSD)
• Intervention / Treatment: Device: Allium " Bulbar Urethral Stent " (BUS) system

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Pierre Bénite cedex, France, 69495
    • Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allium BUS; Temporary urethral stent	Device: Allium " Bulbar Urethral Stent " (BUS) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Detrusor striated sphincter dyssynergia; Temporary urethral stent
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Ataxia
• Other Study ID Numbers: 2014.861