Efficacy of Two Onabotulinum Toxin Doses

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388086
• Other study ID #: 2017-17
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Overactive Detrusor
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive

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