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

Primary Purpose

Spinal Cord Injuries, Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Onabotulinumtoxin A
Placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injury, Neurogenic overactive bladder, Onabotulinum toxin A, Prevention, Botulinum Toxins, Type A

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnaas Hospital
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Onabotulinumtoxin A

Arm Description

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

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

Outcomes

Primary Outcome Measures

Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.

Secondary Outcome Measures

Urodynamic parameters
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.
Occurrence of complications.

Full Information

First Posted
September 26, 2012
Last Updated
November 22, 2022
Sponsor
Oslo University Hospital
Collaborators
Sunnaas Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01698138
Brief Title
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
Acronym
BOT-SCI
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sunnaas Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Urinary Bladder, Overactive
Keywords
Spinal cord injury, Neurogenic overactive bladder, Onabotulinum toxin A, Prevention, Botulinum Toxins, Type A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 transurethral injections, each of 1 ml solution containing NaCl.
Arm Title
Onabotulinumtoxin A
Arm Type
Active Comparator
Arm Description
30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
Intervention Type
Drug
Intervention Name(s)
Onabotulinumtoxin A
Other Intervention Name(s)
Botox ®, "Allergan"
Intervention Description
30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl
Intervention Description
30 transurethral injections, each of 1 ml solution containing NaCl.
Primary Outcome Measure Information:
Title
Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Urodynamic parameters
Description
Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.
Time Frame
12 months
Title
Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.
Time Frame
12 months
Title
Occurrence of complications.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Detrusor pathophysiology
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Frich, MD, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ole Jacob Nilsen, MD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Glott, MD
Organizational Affiliation
Sunnaas Rehabilitation Hospital, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnaas Hospital
City
Nesoddtangen
ZIP/Postal Code
1450
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

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Prevention of Bladder Dysfunction in Acute Spinal Cord Injury

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