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Prevention of bladder dysfunction in acute spinal cord injury with Onabotulinumtoxin A

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 in patients with detrusor overactivity due to spinal cord injury

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002211-25-NO
Enrollment
Unknown
Registered
2012-10-09
Start date
2013-04-08
Completion date
Unknown
Last updated
2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder dysfunction after acute spinal cord injury

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Powder for concentrate for solution for injection/infusion Pharmaceutical form of the placebo: Injection Route of administration of the place

Sponsors

Oslo University Hospital, Dept of Urology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Acute spinal cord injury within 4 weeks of the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No former neurological disease Not willing to give informed consent Age below 18 years

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate if intravesical injection of Botox can prevent the development of bladder dysfunction after spinal cord injury;Secondary Objective: Monitor patients for complications;Primary end point(s): Development of detrusor overactivity Change in urodynamic parameters ;Timepoint(s) of evaluation of this end point: After 3, 6, 9 and 12 months—

Secondary

MeasureTime frame
Secondary end point(s): Complications;Timepoint(s) of evaluation of this end point: 3, 6, 9 and 12 months—

Countries

Norway

Contacts

Public ContactDept of Urology, Reconstructive uro

Oslo University Hospital

ole.jacob.nilsen@ous-hf.no4723070000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026