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Clinical Trials/NCT03388086
NCT03388086
Completed
N/A

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

Swiss Paraplegic Research, Nottwil1 site in 1 country56 target enrollmentFebruary 1, 2018

Overview

Phase
N/A
Intervention
Injection of Onabotulinum toxin
Conditions
Neurogenic Bladder
Sponsor
Swiss Paraplegic Research, Nottwil
Enrollment
56
Locations
1
Primary Endpoint
change in detrusor pressure post-injection
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Onabotulinum 300 units

Intervention: Injection of Onabotulinum toxin

Onabotulinum 200 units

Intervention: Injection of Onabotulinum toxin

Outcomes

Primary Outcomes

change in detrusor pressure post-injection

Time Frame: within 3 months before injection; within 2 months after injection

bladder detrusor pressure during storage phase

Secondary Outcomes

  • reflexive bladder volume(within 3 months before injection; within 2 months after injection)
  • complications(within 2 months after injection)
  • maximum bladder volume(within 3 months before injection; within 2 months after injection)
  • bladder compliance(within 3 months before injection; within 2 months after injection)
  • presence of urinary incontinence(within 3 months before injection; within 2 months after injection)

Study Sites (1)

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