Prevention of Bladder Dysfunction in Acute Spinal Cord Injury (BOT-SCI)
This study is ongoing, but not recruiting participants.
Sponsor:
Oslo University Hospital
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: September 28, 2012
Last verified: September 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698138
Locations
| Norway | |
| Sunnaas Hospital | |
| Nesoddtangen, Norway, 1450 | |
| 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, 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: | September 28, 2012 |
| 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 Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries 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 June 17, 2013