Prevention of Bladder Dysfunction in Acute Spinal Cord Injury (NCT01698138) | Clinical Trial Compass
CompletedPhase 4
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
Norway20 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O.