Spinal Cord InjuriesPhase 4BOT-SCINCT01698138
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
A Phase 4 study testing Onabotulinumtoxin A in people with Spinal Cord Injuries and Urinary Bladder, Overactive, run by Oslo University Hospital at 2 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Urinary Bladder, Overactive
- What is being tested?
- Onabotulinumtoxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2012to 20 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sunnaas Hospital
Nesoddtangen, 1450
Oslo University Hospital
Oslo, 0027
About this study
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
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.
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Overactive
- Being tested
- Onabotulinumtoxin A, Placebo
- Keywords
- Spinal cord injury, Neurogenic overactive bladder, Onabotulinum toxin A, Prevention, Botulinum Toxins, Type A
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxin ADrug
Also called Botox ®, "Allergan"
30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %.
PlaceboDrug
Also called NaCl
30 transurethral injections, each of 1 ml solution containing NaCl.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 30 transurethral injections, each of 1 ml solution containing NaCl. Receives: Drug: Placebo |
| Onabotulinumtoxin A | Active comparator | 30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %. Receives: Drug: Onabotulinumtoxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.
Measured: 12 months
Secondary outcomes (3)
Urodynamic parameters
Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD.
Measured: 12 months
Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment.
Measured: 12 months
Occurrence of complications.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital
- Responsible party
- Principal investigator, Lars Frich, Oslo University Hospital
- Investigators
- Lars Frich, MD, PhD, Principal investigator, University of OsloOle Jacob Nilsen, MD, Principal investigator, University of OsloThomas Glott, MD, Principal investigator, Sunnaas Rehabilitation Hospital, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698138
- Sponsor's protocol ID
- 2012/1151
- Acronym
- BOT-SCI
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2012
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01698138
- Acronym / sponsor ID
- BOT-SCI / 2012/1151
- Conditions
- Spinal Cord Injuries, Urinary Bladder, Overactive
- Keywords
- Spinal cord injury, Neurogenic overactive bladder, Onabotulinum toxin A, Prevention, Botulinum Toxins, Type A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital
- Study start
- Sep 2012
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo30 transurethral injections, each of 1 ml solution containing NaCl. |
| Onabotulinumtoxin A | Active comparator | Drug: Onabotulinumtoxin A30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onabotulinumtoxin AAlso: Botox ®, "Allergan"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 |
| PlaceboAlso: NaCl30 transurethral injections, each of 1 ml solution containing NaCl. | Drug | Placebo |
Primary outcome
Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.
Time frame: 12 months
3 secondary outcomes
Urodynamic parameters
Time frame: 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Frich, MD, PhD principal investigator
University of Oslo
Ole Jacob Nilsen, MD principal investigator
University of Oslo
Thomas Glott, MD principal investigator
Sunnaas Rehabilitation Hospital, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Onabotulinumtoxin A in people with Spinal Cord Injuries and Urinary Bladder, Overactive, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.