Trial | NCT01698138  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
Study Started
Sep 30
2012
Primary Completion
Dec 20
2020
Study Completion
Dec 20
2020
Last Update
Nov 23
2022

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 %.

  • Other names: Botox ®, "Allergan"

Drug Placebo

30 transurethral injections, each of 1 ml solution containing NaCl.

  • Other names: NaCl

Placebo Placebo Comparator

30 transurethral injections, each of 1 ml solution containing NaCl.

Onabotulinumtoxin A Active Comparator

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

Criteria 

Inclusion Criteria:

Patients with documented acute, motor complete C6 to Th11 spinal cord injury
Patients can be included in the study less than four weeks after injury
Male or female, aged 18 to 80 years old
Patient weight > 40 kg
Patient is able and willing to sign informed consent
Patient is able to complete all study requirements

Exclusion Criteria:

Neurogenic detrusor overactivity with contractions greater than 40 cm H2O at first visit
History or evidence of previous urological abnormalities, disease or surgery, except bladder dysfunction after spinal cord injury
History of haematuria or ongoing haematuria, if the hematuria is determined to be a pathologic condition or is uninvestigated
Pregnancy or females of childbearing potential unwilling to use a reliable form of contraception
Breastfeeding
Known allergy to Onabotulinumtoxin A
Grave psychiatric disorder
Use of anti-platelet or anti-coagulant other than low molecular weight heparin (LMWH) or acetylsalicylic acid
Haemophilia or other clotting disorders that cause bleeding diathesis
Treatment with antimuscarinic medication within 3 months of randomization
Treatment with botulinum toxin of any serotype within 3 months of randomization
Patient has been immunized for any botulinum toxin serotype
Patient has any medical condition that may put the patient at increased risk with exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis
Patient has any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
No Results Posted