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OpenTrials
Completed

NCT Number: NCT02323243

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

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allium " Bulbar Urethral Stent " (BUS) system

Device

Primary outcomes

  1. Percentage of patients who perceive their voiding condition improved or very improved

    Time frame: One month after the surgical intervention

    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 outcomes

  1. Number of stents correctly positioned

    Time frame: Immediately after the surgical intervention

  2. Number of stent migrations

    Time frame: 1 month, 3 months, 6 months and 12 months after the surgical intervention

  3. Number of stent removals performed without hemorrhage

    Time frame: 12 months after the surgical intervention

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ALLIUM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.