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| Name | Class |
|---|---|
| Sunnaas Rehabilitation Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 30 transurethral injections, each of 1 ml solution containing NaCl. |
|
| 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 %. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onabotulinumtoxin A | Drug | 30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, "Allergan") in 30 ml of NaCl 0.9 %. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of neurogenic detrusor overactivity during cystometry, defined as contractions with amplitudes above 40 cm H2O. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Urodynamic parameters | Maximal detrusor pressure (cmH2O), maximal bladder capacity (ml), compliance (ΔcmH2O/Δml), and occurrence of DSD. | 12 months |
| Quality of life (QOL) in the treated group compared to the placebo group 12 months after first treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Detrusor pathophysiology | 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Frich, MD, PhD | University of Oslo | Principal Investigator |
| Ole Jacob Nilsen, MD | University of Oslo | Principal Investigator |
| Thomas Glott, MD | Sunnaas Rehabilitation Hospital, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnaas Hospital | Nesoddtangen | 1450 | Norway | |||
| Oslo University Hospital |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Placebo | Drug | 30 transurethral injections, each of 1 ml solution containing NaCl. |
|
|
| 12 months |
| Occurrence of complications. | 12 months |
| Oslo |
| 0027 |
| Norway |
| D014947 | Wounds and Injuries |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |