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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Oslo University Hospital
Sunnaas Rehabilitation Hospital
Information provided by (Responsible Party):
Lars Frich, Oslo University Hospital Identifier:
First received: September 26, 2012
Last updated: February 7, 2017
Last verified: February 2017
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 Intervention Phase
Spinal Cord Injuries
Urinary Bladder, Overactive
Drug: Onabotulinumtoxin A
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Urodynamic parameters [ Time Frame: 12 months ]
    Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.

  • Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment. [ Time Frame: 12 months ]
  • Occurrence of complications. [ Time Frame: 12 months ]

Other Outcome Measures:
  • Detrusor pathophysiology [ Time Frame: 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.

Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Botox ®, "Allergan"


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01698138

Contact: Ole Jacob Nilsen, MD. +47 23070000
Contact: Thomas Glott, MD. +47 66969000

Sunnaas Hospital Recruiting
Nesoddtangen, Norway, 1450
Contact: Thomas Glott, MD.    +47 66969000   
Principal Investigator: Thomas Glott, MD.         
Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Ole Jacob Nilsen, MD.    +47 23070000   
Contact: Lars Frich, MD. PhD.    +47 23070000   
Principal Investigator: Lars Frich, MD, PhD.         
Sub-Investigator: Ole Jacob Nilsen, MD.         
Sponsors and Collaborators
Oslo University Hospital
Sunnaas Rehabilitation Hospital
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
  More Information

Responsible Party: Lars Frich, MD, PhD, Oslo University Hospital Identifier: NCT01698138     History of Changes
Other Study ID Numbers: 2012/1151
Study First Received: September 26, 2012
Last Updated: February 7, 2017

Keywords provided by Oslo University Hospital:
Spinal cord injury
Neurogenic overactive bladder
Onabotulinum toxin A
Botulinum Toxins, Type A

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Urinary Bladder, Overactive
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on April 26, 2017