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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Detrusor Striated Sphincter Dyssynergia (DSSD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allium BUS

Temporary urethral stent

Group Type EXPERIMENTAL

Allium " Bulbar Urethral Stent " (BUS) system

Intervention Type DEVICE

Interventions

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Allium " Bulbar Urethral Stent " (BUS) system

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No