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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03388086
Other study ID # 2017-17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date July 31, 2019

Study information

Verified date August 2019
Source Swiss Paraplegic Centre Nottwil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date July 31, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

Drug:
Injection of Onabotulinum toxin
multiple injections of Onabotulinum toxin into the detrusor muscle

Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil LU

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other lesion level at the time of spinal cord injury
Other lesion severity at the time of spinal cord injury
Other method of bladder evacuation evacuation by intermittent catheterization, reflex voiding, suprapubic catheter , electric stimulation within 2 months after injection
Primary change in detrusor pressure post-injection bladder detrusor pressure during storage phase within 3 months before injection; within 2 months after injection
Secondary maximum bladder volume within 3 months before injection; within 2 months after injection
Secondary bladder compliance The relationship between a change in bladder volume and the change in detrusor pressure (?DV/?DP). within 3 months before injection; within 2 months after injection
Secondary reflexive bladder volume within 3 months before injection; within 2 months after injection
Secondary complications within 2 months after injection
Secondary presence of urinary incontinence within 3 months before injection; within 2 months after injection
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