BOT-SCI: Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01698138
Collaborator
Sunnaas Rehabilitation Hospital (Other)
20
2
2
99.6
10
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Onabotulinumtoxin A
  • Drug: Placebo
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 20, 2020
Anticipated Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

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

Drug: Placebo
30 transurethral injections, each of 1 ml solution containing NaCl.
Other Names:
  • NaCl
  • Active Comparator: 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: 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"
  • Outcome Measures

    Primary Outcome Measures

    1. Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O. [12 months]

    Secondary Outcome Measures

    1. Urodynamic parameters [12 months]

      Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.

    2. Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment. [12 months]

    3. Occurrence of complications. [12 months]

    Other Outcome Measures

    1. Detrusor pathophysiology [12 months]

      Differences in levels of transmitters and receptors relevant to development of bladder dysfunction, measured in urine samples and bladder biopsies, to gain knowledge of the pathophysiology behind neurogenic detrusor overactivity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnaas Hospital Nesoddtangen Norway 1450
    2 Oslo University Hospital Oslo Norway 0027

    Sponsors and Collaborators

    • Oslo University Hospital
    • Sunnaas Rehabilitation Hospital

    Investigators

    • Principal Investigator: Lars Frich, MD, PhD, University of Oslo
    • Principal Investigator: Ole Jacob Nilsen, MD, University of Oslo
    • Principal Investigator: Thomas Glott, MD, Sunnaas Rehabilitation Hospital, Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lars Frich, MD, PhD, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01698138
    Other Study ID Numbers:
    • 2012/1151
    First Posted:
    Oct 2, 2012
    Last Update Posted:
    Dec 30, 2020
    Last Verified:
    Dec 1, 2020

    Study Results

    No Results Posted as of Dec 30, 2020