NCT01698138

Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

Prevention of Bladder Dysfunction in Acute Spinal Cord Injury. A Double-blind, Randomized, Placebo-controlled Study to Explore the Effect of Early Treatment With Onabotulinumtoxin A on Development of Detrusor Overactivity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries
• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	Onabotulinumtoxin A	30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
DRUG	Placebo	30 transurethral injections, each of 1 ml solution containing NaCl.

Timeline

• Start date: 2012-09-01
• Primary completion: 2020-12-20
• Completion: 2020-12-20
• First posted: 2012-10-02
• Last updated: 2022-11-23

Locations

2 sites across 1 country: Norway