Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
NCT Number: NCT02323243
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.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 1 / Phase 2
Pierre-Bénite, 69495, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Immediately after the surgical intervention
Time frame: 1 month, 3 months, 6 months and 12 months after the surgical intervention
Time frame: 12 months after the surgical intervention
Time frame: Up to 12 months after the surgical intervention
Time frame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Time frame: At inclusion, 1 month, 3 months, 6 months and 12 months after the surgical intervention
Time frame: At inclusion and 1 month, 3 months, 6 months and 12 months after the surgical intervention
Time frame: Up to 12 months following the surgical intervention
Hospices Civils de Lyon
Other
Acronym: ALLIUM
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.