Skip to content

Efficacy of Two Onabotulinum Toxin Doses

Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03388086
Enrollment
56
Registered
2018-01-02
Start date
2018-02-01
Completion date
2019-07-31
Last updated
2019-08-06

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

Conditions

Neurogenic Bladder, Overactive Detrusor

Brief summary

The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.

Interventions

DRUGInjection of Onabotulinum toxin

multiple injections of Onabotulinum toxin into the detrusor muscle

Sponsors

Swiss Paraplegic Research, Nottwil
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* neurogenic detrusor overactivity * spinal cord injury * Onabotulinum toxin injections into the detrusor from 2000-2017

Exclusion criteria

* missing urodynamic values before or after Onabotulinum toxin injections

Design outcomes

Primary

MeasureTime frameDescription
change in detrusor pressure post-injectionwithin 3 months before injection; within 2 months after injectionbladder detrusor pressure during storage phase

Secondary

MeasureTime frameDescription
bladder compliancewithin 3 months before injection; within 2 months after injectionThe relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
reflexive bladder volumewithin 3 months before injection; within 2 months after injection
complicationswithin 2 months after injection
presence of urinary incontinencewithin 3 months before injection; within 2 months after injection
maximum bladder volumewithin 3 months before injection; within 2 months after injection

Other

MeasureTime frameDescription
lesion levelat the time of spinal cord injury
method of bladder evacuationwithin 2 months after injectionevacuation by intermittent catheterization, reflex voiding, suprapubic catheter , electric stimulation
lesion severityat the time of spinal cord injury

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026