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

Primary Purpose

Detrusor Striated Sphincter Dyssynergia (DSSD)

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Allium " Bulbar Urethral Stent " (BUS) system
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Striated Sphincter Dyssynergia (DSSD) focused on measuring Detrusor striated sphincter dyssynergia, Temporary urethral stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy 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.

Sites / Locations

  • Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allium BUS

Arm Description

Temporary urethral stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of stents correctly positioned
Number of stent migrations
Number of stent removals performed without hemorrhage
Number of complications, i.e. symptomatic urinary tract infections, encrustations, stenosis and hematuria, need for re-intervention and removals of the stent
Post-void residual volume measured by retrograde urinary urethrocystography
Maximum detrusor pressure and maximum urethral closure pressure, measured during the urodynamic testing
QUALIVEEN short form score (approved in French)
Number of patients requesting a change in the voiding method, i.e. premature removal of the stent

Full Information

First Posted
December 12, 2014
Last Updated
August 2, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02323243
Brief Title
Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
Acronym
ALLIUM
Official Title
Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Striated Sphincter Dyssynergia (DSSD)
Keywords
Detrusor striated sphincter dyssynergia, Temporary urethral stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allium BUS
Arm Type
Experimental
Arm Description
Temporary urethral stent
Intervention Type
Device
Intervention Name(s)
Allium " Bulbar Urethral Stent " (BUS) system
Primary Outcome Measure Information:
Title
Percentage of patients who perceive their voiding condition improved or very improved
Description
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
Secondary Outcome Measure Information:
Title
Number of stents correctly positioned
Time Frame
Immediately after the surgical intervention
Title
Number of stent migrations
Time Frame
1 month, 3 months, 6 months and 12 months after the surgical intervention
Title
Number of stent removals performed without hemorrhage
Time Frame
12 months after the surgical intervention
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud
City
Pierre Bénite cedex
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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