Efficacy of Two Onabotulinum Toxin Doses

Completed

• Conditions: Neurogenic Bladder; Overactive Detrusor
• Interventions: Drug: Injection of Onabotulinum toxin

• Registration Number: NCT03388086
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Study Start: 2018-02-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Onabotulinum 300 units	Injection of Onabotulinum toxin	-
Onabotulinum 200 units	Injection of Onabotulinum toxin	-

Primary Outcome Measures

Name	Time	Method
change in detrusor pressure post-injection	within 3 months before injection; within 2 months after injection	bladder detrusor pressure during storage phase

Secondary Outcome Measures

Name	Time	Method
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	The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
presence of urinary incontinence	within 3 months before injection; within 2 months after injection

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland