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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Oslo University Hospital
Sponsor:
Collaborator:
Sunnaas Rehabilitation Hospital
Information provided by (Responsible Party):
Lars Frich, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01698138
First received: September 26, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urodynamic parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Occurrence of complications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Detrusor pathophysiology [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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: September 2016
Estimated Primary Completion Date: September 2015 (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"

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01698138

Contacts
Contact: Ole Jacob Nilsen, MD. +47 23070000 ojnilsen@ous-hf.no
Contact: Thomas Glott, MD. +47 66969000 thomas.glott@sunnaas.no

Locations
Norway
Sunnaas Hospital Recruiting
Nesoddtangen, Norway, 1450
Contact: Thomas Glott, MD.    +47 66969000    thomas.glott@sunnaas.no   
Principal Investigator: Thomas Glott, MD.         
Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Ole Jacob Nilsen, MD.    +47 23070000    ojnilsen@ous-hf.no   
Contact: Lars Frich, MD. PhD.    +47 23070000    lfrich@ous-hf.no   
Principal Investigator: Lars Frich, MD, PhD.         
Sub-Investigator: Ole Jacob Nilsen, MD.         
Sponsors and Collaborators
Oslo University Hospital
Sunnaas Rehabilitation Hospital
Investigators
Principal Investigator: Lars Frich, MD, PhD University of Oslo, Norway
Principal Investigator: Ole Jacob Nilsen, MD University of Oslo, Norway
Principal Investigator: Thomas Glott, MD Sunnaas Rehabilitation Hospital, Norway
  More Information

No publications provided

Responsible Party: Lars Frich, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01698138     History of Changes
Other Study ID Numbers: 2012/1151
Study First Received: September 26, 2012
Last Updated: May 15, 2014
Health Authority: Norway: Regional Committee for Medical and Health Research Ethic (REK), South East

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Bladder, Overactive
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014