Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
Status:
Active, not recruiting
Trial end date:
2020-12-20
Target enrollment:
Participant gender:
Summary
This study is a double blind, randomized, placebo controlled trial to explore the effect of
early treatment with Onabotulinumtoxin A in patients with acute complete motor spinal cord
injury (SCI) on the development of neurogenic detrusor overactivity (NDO). A total of 20
patients will be randomized to intra-detrusor injection of 300 U Onabotulinumtoxin A in 30 ml
NaCl 0.9 % or placebo with 30 ml NaCl 0.9 %. Bladder biopsies will be obtained in the same
procedure. The treatment will be repeated after three months. All included patients will be
evaluated with urodynamic examinations. Follow-up is 12 months after the first treatment. The
primary endpoint of the study is development of NDO.
Phase:
Phase 4
Details
Lead Sponsor:
Oslo University Hospital
Collaborator:
Sunnaas Rehabilitation Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA Pharmaceutical Solutions